Cerebral Palsy
Conditions
Keywords
umbilical cord blood, stem cell, cerebral palsy
Brief summary
This randomized control study is aimed to determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy.
Detailed description
Cerebral palsy is a disorder of movement and posture that result from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability through one's life. Umbilical cord blood(UCB) is suggested as therapeutic method for cerebral palsy which resulted from animal studies. Stem cells included in UCB is expected to exert therapeutic efficacy for functional recovery. It is also suggested that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed to be neuroprotection and neurogenesis which would reinforce the effect of stem cell as well. Although autologous umbilical cord would be safe, the children who have problems at birth seldom have autologous umbilical cord blood. Allogenic umbilical cord blood might be useful for these children if its effect is approved.
Interventions
BIOLOGICALUmbilical Cord Blood Infusion
The subjects will be undertaken allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg) intravenously under non-myeloablative immunosuppression (maintaining blood level of cyclosporine as 100-200ng/mL for 1 month).
Erythropoietin will be given as the schedule of twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times.
All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.
Placebo Umbilical Cord Blood will be given except the Experimental arm. Placebo Umbilical Cord Blood was made using peripheral blood. Participants and Investigators maintained as blind.
Placebo Erythropoietin containing Normal Saline
Sponsors
Sung Kwang Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Months to 10 Years
Healthy volunteers
No
Inclusion criteria
* Known cerebral palsy * Willing to comply with all study procedure
Exclusion criteria
* High risk of pneumonia or renal function deterioration after using of immunosuppressant * Presence of known genetic disease * Possibility of drug hypersensitivity which is related to this study remedy * History of previous cell therapy * Poor cooperation of guardian,including inactive attitude for rehabilitation * Intractable seizure disorder * Autism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Motor Performance | Baseline -1 month - 3 months - 6 months | GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0\ 100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones. |
| Changes in Standardized Gross Motor Function | Baseline - 1 month - 3 months - 6 months | GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0\ 100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Brain MRI | Baseline - 6 months | Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter. |
| Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Baseline - 2 weeks | 18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that 1 refers to INCREASED areas, -1, DECREASED areas and 0, just NO CHANGE. |
| Changes in Functional Performance in Daily Activities | Baseline -1 month - 3 months - 6 months | Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point. |
| Changes in Cognitive Neurodevelopmental Outcome | Baseline -1 month - 3 months - 6 months | Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones. |
| Changes in Muscle Strength | Baseline - 1 month - 3 months - 6 months | Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 \ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point. |
| Changes in Hand Function | Baseline - 1 month - 3 months - 6 months | QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times. |
| Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant | 6 months | The number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator. |
| Changes in Functional Independence in Daily Activities | Baseline - 1 month - 3 months - 6 months | WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point. |
| Changes in Motor Neurodevelopmental Outcome | Baseline - 1 month - 3 months - 6 months | Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones. |
Countries
South Korea
Participant flow
Recruitment details
Enrollment Period: May 31, 2010 through April 9, 2011 All participants were recruited at CHA Bundang Medical Center.
Pre-assignment details
We tried to recruit 106 subjects. Finally 105 patients were enrolled at the beginning of the overall study and none of the participants were washed out before assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation | 35 |
| Erythropoietin & Rehabilitation Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation | 36 |
| Only Rehabilitation Active rehabilitation | 34 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 1 |
Baseline characteristics
| Characteristic | Erythropoietin & Rehabilitation | Only Rehabilitation | Umbilical Cord Blood & Erythropoietin & Rehabilitation | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 36 Participants | 34 Participants | 35 Participants | 105 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 50.05 months STANDARD_DEVIATION 24.45 | 46.0 months STANDARD_DEVIATION 19.58 | 45.71 months STANDARD_DEVIATION 18.91 | 47.30 months STANDARD_DEVIATION 21.07 |
| Region of Enrollment Korea, Republic of | 36 participants | 34 participants | 35 participants | 105 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 13 Participants | 33 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 22 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 35 | 29 / 36 | 32 / 34 |
| serious Total, serious adverse events | 3 / 35 | 3 / 6 | 3 / 8 |
Outcome results
Primary
Changes in Motor Performance
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0\ 100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.
Time frame: Baseline -1 month - 3 months - 6 months
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Performance | 1 month - Baseline | 7.00 units on a scale | Standard Error 1.3 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Performance | 3 months - 1 month | 4.5 units on a scale | Standard Error 0.7 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Performance | 6 months - Baseline | 14.5 units on a scale | Standard Error 1.8 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Performance | Baseline | 34.5 units on a scale | Standard Error 2.7 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Performance | 6 months - 3 months | 3.1 units on a scale | Standard Error 0.6 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Performance | 6 months - 1 month | 7.5 units on a scale | Standard Error 0.9 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Performance | 3 months - Baseline | 11.5 units on a scale | Standard Error 1.5 |
| Erythropoietin & Rehabilitation | Changes in Motor Performance | 6 months - Baseline | 9.2 units on a scale | Standard Error 0.8 |
| Erythropoietin & Rehabilitation | Changes in Motor Performance | Baseline | 38.2 units on a scale | Standard Error 2.8 |
| Erythropoietin & Rehabilitation | Changes in Motor Performance | 1 month - Baseline | 4.5 units on a scale | Standard Error 0.6 |
| Erythropoietin & Rehabilitation | Changes in Motor Performance | 3 months - Baseline | 7.5 units on a scale | Standard Error 0.8 |
| Erythropoietin & Rehabilitation | Changes in Motor Performance | 3 months - 1 month | 2.9 units on a scale | Standard Error 0.5 |
| Erythropoietin & Rehabilitation | Changes in Motor Performance | 6 months - 1 month | 4.7 units on a scale | Standard Error 0.7 |
| Erythropoietin & Rehabilitation | Changes in Motor Performance | 6 months - 3 months | 1.7 units on a scale | Standard Error 0.5 |
| Only Rehabilitation | Changes in Motor Performance | 3 months - 1 month | 2.1 units on a scale | Standard Error 0.6 |
| Only Rehabilitation | Changes in Motor Performance | 1 month - Baseline | 6.0 units on a scale | Standard Error 1 |
| Only Rehabilitation | Changes in Motor Performance | 6 months - 3 months | 1.5 units on a scale | Standard Error 0.4 |
| Only Rehabilitation | Changes in Motor Performance | 6 months - 1 month | 3.6 units on a scale | Standard Error 0.7 |
| Only Rehabilitation | Changes in Motor Performance | 6 months - Baseline | 9.6 units on a scale | Standard Error 1.2 |
| Only Rehabilitation | Changes in Motor Performance | 3 months - Baseline | 8.1 units on a scale | Standard Error 1.2 |
| Only Rehabilitation | Changes in Motor Performance | Baseline | 35.5 units on a scale | Standard Error 2.9 |
Comparison: In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.p-value: <0.05Repeated Measure ANOVA
Primary
Changes in Standardized Gross Motor Function
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0\ 100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.
Time frame: Baseline - 1 month - 3 months - 6 months
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 1 month - Baseline | 3.7 units on a scale | Standard Error 0.4 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 3 months - 1 month | 2.9 units on a scale | Standard Error 0.8 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 6 months - Baseline | 9.1 units on a scale | Standard Error 1.2 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | Baseline | 36.0 units on a scale | Standard Error 4.7 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 6 months - 3 months | 2.6 units on a scale | Standard Error 0.5 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 6 months - 1 month | 5.4 units on a scale | Standard Error 1.2 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 3 months - Baseline | 6.5 units on a scale | Standard Error 0.9 |
| Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 6 months - Baseline | 9.0 units on a scale | Standard Error 1.1 |
| Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | Baseline | 42.6 units on a scale | Standard Error 4.9 |
| Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 1 month - Baseline | 4.3 units on a scale | Standard Error 0.5 |
| Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 3 months - Baseline | 6.8 units on a scale | Standard Error 0.8 |
| Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 3 months - 1 month | 2.5 units on a scale | Standard Error 0.5 |
| Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 6 months - 1 month | 4.7 units on a scale | Standard Error 0.9 |
| Erythropoietin & Rehabilitation | Changes in Standardized Gross Motor Function | 6 months - 3 months | 2.2 units on a scale | Standard Error 0.6 |
| Only Rehabilitation | Changes in Standardized Gross Motor Function | 3 months - 1 month | 1.8 units on a scale | Standard Error 0.4 |
| Only Rehabilitation | Changes in Standardized Gross Motor Function | 1 month - Baseline | 4.6 units on a scale | Standard Error 0.6 |
| Only Rehabilitation | Changes in Standardized Gross Motor Function | 6 months - 3 months | 1.3 units on a scale | Standard Error 0.4 |
| Only Rehabilitation | Changes in Standardized Gross Motor Function | 6 months - 1 month | 3.1 units on a scale | Standard Error 0.6 |
| Only Rehabilitation | Changes in Standardized Gross Motor Function | 6 months - Baseline | 7.8 units on a scale | Standard Error 0.9 |
| Only Rehabilitation | Changes in Standardized Gross Motor Function | 3 months - Baseline | 6.4 units on a scale | Standard Error 0.7 |
| Only Rehabilitation | Changes in Standardized Gross Motor Function | Baseline | 36.8 units on a scale | Standard Error 4.5 |
Comparison: In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.p-value: <0.05Repeated Measure ANOVA
Secondary
Changes in Brain MRI
Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter.
Time frame: Baseline - 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Brain MRI | Anterior portion of Rt. posterior Internal Capsule | 0.03 units on a scale | Standard Error 0.01 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Brain MRI | Posterior portion of Rt posterior Internal Capsule | 0.04 units on a scale | Standard Error 0.01 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Brain MRI | Anterior portion of Lt. posterior Internal Capsule | 0.03 units on a scale | Standard Error 0.01 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Brain MRI | Posterior portion of Lt posterior Internal Capsule | 0.05 units on a scale | Standard Error 0.02 |
| Erythropoietin & Rehabilitation | Changes in Brain MRI | Posterior portion of Lt posterior Internal Capsule | 0.04 units on a scale | Standard Error 0.02 |
| Erythropoietin & Rehabilitation | Changes in Brain MRI | Anterior portion of Rt. posterior Internal Capsule | 0.01 units on a scale | Standard Error 0.01 |
| Erythropoietin & Rehabilitation | Changes in Brain MRI | Anterior portion of Lt. posterior Internal Capsule | 0.02 units on a scale | Standard Error 0.01 |
| Erythropoietin & Rehabilitation | Changes in Brain MRI | Posterior portion of Rt posterior Internal Capsule | 0.02 units on a scale | Standard Error 0.01 |
| Only Rehabilitation | Changes in Brain MRI | Posterior portion of Lt posterior Internal Capsule | 0.05 units on a scale | Standard Error 0.02 |
| Only Rehabilitation | Changes in Brain MRI | Posterior portion of Rt posterior Internal Capsule | 0.02 units on a scale | Standard Error 0.02 |
| Only Rehabilitation | Changes in Brain MRI | Anterior portion of Lt. posterior Internal Capsule | 0.04 units on a scale | Standard Error 0.02 |
| Only Rehabilitation | Changes in Brain MRI | Anterior portion of Rt. posterior Internal Capsule | 0.01 units on a scale | Standard Error 0.01 |
Secondary
Changes in Cognitive Neurodevelopmental Outcome
Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.
Time frame: Baseline -1 month - 3 months - 6 months
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 1 month - Baseline | 8.2 units on a scale | Standard Error 1.3 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 3 months - 1 month | 3.8 units on a scale | Standard Error 0.8 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 6 months - Baseline | 17.6 units on a scale | Standard Error 1.8 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: Baseline | 94.1 units on a scale | Standard Error 9.1 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 6 months - 3 months | 5.6 units on a scale | Standard Error 1.2 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 6 months - 1 month | 9.4 units on a scale | Standard Error 1.4 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 3 months - Baseline | 12.0 units on a scale | Standard Error 1.4 |
| Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 6 months - Baseline | 11.5 units on a scale | Standard Error 1.3 |
| Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: Baseline | 105.9 units on a scale | Standard Error 8.9 |
| Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 1 month - Baseline | 3.4 units on a scale | Standard Error 0.5 |
| Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 3 months - Baseline | 7.4 units on a scale | Standard Error 0.9 |
| Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 3 months - 1 month | 4.0 units on a scale | Standard Error 0.7 |
| Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 6 months - 1 month | 8.1 units on a scale | Standard Error 1.3 |
| Erythropoietin & Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 6 months - 3 months | 4.1 units on a scale | Standard Error 0.8 |
| Only Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 3 months - 1 month | 2.5 units on a scale | Standard Error 0.7 |
| Only Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 1 month - Baseline | 3.3 units on a scale | Standard Error 0.6 |
| Only Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 6 months - 3 months | 4.1 units on a scale | Standard Error 1 |
| Only Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 6 months - 1 month | 6.6 units on a scale | Standard Error 1.4 |
| Only Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 6 months - Baseline | 9.9 units on a scale | Standard Error 1.6 |
| Only Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: 3 months - Baseline | 5.8 units on a scale | Standard Error 0.8 |
| Only Rehabilitation | Changes in Cognitive Neurodevelopmental Outcome | BSID-II Mental Scale: Baseline | 86.6 units on a scale | Standard Error 9 |
Comparison: The null hypothesis is that in terms of K-BSID-II MENTAL Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.p-value: <0.05Repeated Measure ANOVA
Secondary
Changes in Functional Independence in Daily Activities
WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point.
Time frame: Baseline - 1 month - 3 months - 6 months
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Independence in Daily Activities | Baseline | 34.1 units on a scale | Standard Error 3.8 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Independence in Daily Activities | 1 month | 35.6 units on a scale | Standard Error 4.1 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Independence in Daily Activities | 3 months | 38.7 units on a scale | Standard Error 4.7 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Independence in Daily Activities | 6 months | 41.1 units on a scale | Standard Error 4.8 |
| Erythropoietin & Rehabilitation | Changes in Functional Independence in Daily Activities | 6 months | 40.3 units on a scale | Standard Error 4.2 |
| Erythropoietin & Rehabilitation | Changes in Functional Independence in Daily Activities | Baseline | 36.6 units on a scale | Standard Error 3.7 |
| Erythropoietin & Rehabilitation | Changes in Functional Independence in Daily Activities | 3 months | 38.5 units on a scale | Standard Error 4.1 |
| Erythropoietin & Rehabilitation | Changes in Functional Independence in Daily Activities | 1 month | 37.5 units on a scale | Standard Error 3.8 |
| Only Rehabilitation | Changes in Functional Independence in Daily Activities | 6 months | 37.7 units on a scale | Standard Error 4.1 |
| Only Rehabilitation | Changes in Functional Independence in Daily Activities | 1 month | 33.2 units on a scale | Standard Error 3.1 |
| Only Rehabilitation | Changes in Functional Independence in Daily Activities | 3 months | 37.1 units on a scale | Standard Error 3.8 |
| Only Rehabilitation | Changes in Functional Independence in Daily Activities | Baseline | 31.4 units on a scale | Standard Error 2.9 |
Comparison: In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.p-value: <0.05Repeated Measure ANOVA
Secondary
Changes in Functional Performance in Daily Activities
Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point.
Time frame: Baseline -1 month - 3 months - 6 months
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: 3 months | 31.7 units on a scale | Standard Error 4.3 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: 1 month | 42.2 units on a scale | Standard Error 2.2 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: 3 months | 44.7 units on a scale | Standard Error 2.4 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: 6 months | 46.5 units on a scale | Standard Error 2.5 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: Baseline | 24.8 units on a scale | Standard Error 3.7 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: 1 month | 28.1 units on a scale | Standard Error 3.9 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: Baseline | 39.1 units on a scale | Standard Error 2.5 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: 6 months | 34.6 units on a scale | Standard Error 4.3 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: Baseline | 40.0 units on a scale | Standard Error 3.5 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: 1 month | 42.8 units on a scale | Standard Error 3.6 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: 3 months | 46.4 units on a scale | Standard Error 3.9 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: 6 months | 49.1 units on a scale | Standard Error 3.6 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: Baseline | 18.0 units on a scale | Standard Error 4.1 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: 1 month | 20.1 units on a scale | Standard Error 4 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: 3 months | 27.0 units on a scale | Standard Error 4.3 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: 6 months | 29.4 units on a scale | Standard Error 4 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of CAS: Baseline | 14.6 units on a scale | Standard Error 4.1 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of CAS: 1 month | 19.6 units on a scale | Standard Error 4.5 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Moblity of CAS: 3 months | 22.5 units on a scale | Standard Error 5.1 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of CAS: 6 months | 24.9 units on a scale | Standard Error 5.5 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: Baseline | 23.0 units on a scale | Standard Error 5.2 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: 1 month | 28.5 units on a scale | Standard Error 5.6 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: 3 months | 34.8 units on a scale | Standard Error 6 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: 6 months | 38.4 units on a scale | Standard Error 6.2 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: 1 month | 30.0 units on a scale | Standard Error 4.5 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: Baseline | 38.2 units on a scale | Standard Error 2.7 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: Baseline | 17.9 units on a scale | Standard Error 3.7 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of CAS: Baseline | 19.7 units on a scale | Standard Error 4.8 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: 1 month | 40.4 units on a scale | Standard Error 2.9 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: 3 months | 45.8 units on a scale | Standard Error 3.3 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: Baseline | 24.7 units on a scale | Standard Error 3.9 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: 3 months | 43.5 units on a scale | Standard Error 2.9 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: 1 month | 21.1 units on a scale | Standard Error 3.8 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: 3 months | 34.2 units on a scale | Standard Error 4.8 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: 6 months | 45.0 units on a scale | Standard Error 2.8 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: 1 month | 42.5 units on a scale | Standard Error 3.3 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of CAS: 1 month | 22.6 units on a scale | Standard Error 4.9 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: Baseline | 29.2 units on a scale | Standard Error 4.3 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: 3 months | 24.2 units on a scale | Standard Error 3.9 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: 6 months | 47.8 units on a scale | Standard Error 3.4 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: 1 month | 32.4 units on a scale | Standard Error 4.3 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: Baseline | 40.1 units on a scale | Standard Error 3.3 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: 6 months | 36.2 units on a scale | Standard Error 4.6 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: 3 months | 34.6 units on a scale | Standard Error 4.3 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: 6 months | 26.0 units on a scale | Standard Error 4.1 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Moblity of CAS: 3 months | 26.0 units on a scale | Standard Error 5.3 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: 6 months | 36.6 units on a scale | Standard Error 4.4 |
| Erythropoietin & Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of CAS: 6 months | 29.2 units on a scale | Standard Error 5.4 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: 6 months | 31.4 units on a scale | Standard Error 3.9 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: Baseline | 34.8 units on a scale | Standard Error 3.5 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: 1 month | 37.5 units on a scale | Standard Error 3.6 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: 3 months | 40.0 units on a scale | Standard Error 3.5 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of CAS: 6 months | 24.0 units on a scale | Standard Error 4.8 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of FSS: 6 months | 42.3 units on a scale | Standard Error 3.9 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: 3 months | 24.2 units on a scale | Standard Error 5 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: Baseline | 15.3 units on a scale | Standard Error 3.2 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: 1 month | 19.0 units on a scale | Standard Error 3.7 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: Baseline | 18.2 units on a scale | Standard Error 4.4 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: 3 months | 21.5 units on a scale | Standard Error 3.7 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: 6 months | 27.6 units on a scale | Standard Error 5.3 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of CAS: 6 months | 23.1 units on a scale | Standard Error 3.9 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: Baseline | 37.4 units on a scale | Standard Error 2.2 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: 1 month | 40.0 units on a scale | Standard Error 2.2 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of CAS: Baseline | 13.5 units on a scale | Standard Error 4 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: 3 months | 41.7 units on a scale | Standard Error 2.3 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Social function of CAS: 1 month | 21.1 units on a scale | Standard Error 4.8 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Self care of FSS: 6 months | 42.8 units on a scale | Standard Error 2.3 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: Baseline | 24.9 units on a scale | Standard Error 3.7 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of CAS: 1 month | 15.6 units on a scale | Standard Error 4.2 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: 1 month | 27.9 units on a scale | Standard Error 3.8 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Mobility of FSS: 3 months | 29.3 units on a scale | Standard Error 3.9 |
| Only Rehabilitation | Changes in Functional Performance in Daily Activities | Moblity of CAS: 3 months | 19.3 units on a scale | Standard Error 4.5 |
Secondary
Changes in Hand Function
QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times.
Time frame: Baseline - 1 month - 3 months - 6 months
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Hand Function | 1 month - Baseline | 5.0 units on a scale | Standard Error 1.4 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Hand Function | 3 months - 1 month | 5.7 units on a scale | Standard Error 1.6 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Hand Function | 6 months - Baseline | 13.9 units on a scale | Standard Error 2.6 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Hand Function | Baseline | 36.0 units on a scale | Standard Error 6.4 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Hand Function | 6 months - 3 months | 2.8 units on a scale | Standard Error 0.8 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Hand Function | 6 months - 1 month | 8.4 units on a scale | Standard Error 2 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Hand Function | 3 months - Baseline | 11.1 units on a scale | Standard Error 2.2 |
| Erythropoietin & Rehabilitation | Changes in Hand Function | 6 months - Baseline | 10.7 units on a scale | Standard Error 2.2 |
| Erythropoietin & Rehabilitation | Changes in Hand Function | Baseline | 52.8 units on a scale | Standard Error 4.9 |
| Erythropoietin & Rehabilitation | Changes in Hand Function | 1 month - Baseline | 5.7 units on a scale | Standard Error 1.7 |
| Erythropoietin & Rehabilitation | Changes in Hand Function | 3 months - Baseline | 8.8 units on a scale | Standard Error 2 |
| Erythropoietin & Rehabilitation | Changes in Hand Function | 3 months - 1 month | 3.1 units on a scale | Standard Error 1 |
| Erythropoietin & Rehabilitation | Changes in Hand Function | 6 months - 1 month | 5.1 units on a scale | Standard Error 1.3 |
| Erythropoietin & Rehabilitation | Changes in Hand Function | 6 months - 3 months | 2.4 units on a scale | Standard Error 0.8 |
| Only Rehabilitation | Changes in Hand Function | 3 months - 1 month | 3.5 units on a scale | Standard Error 1.7 |
| Only Rehabilitation | Changes in Hand Function | 1 month - Baseline | 6.6 units on a scale | Standard Error 1.4 |
| Only Rehabilitation | Changes in Hand Function | 6 months - 3 months | 3.1 units on a scale | Standard Error 1.2 |
| Only Rehabilitation | Changes in Hand Function | 6 months - 1 month | 6.4 units on a scale | Standard Error 2.1 |
| Only Rehabilitation | Changes in Hand Function | 6 months - Baseline | 13.0 units on a scale | Standard Error 2.4 |
| Only Rehabilitation | Changes in Hand Function | 3 months - Baseline | 10.5 units on a scale | Standard Error 1.8 |
| Only Rehabilitation | Changes in Hand Function | Baseline | 43.0 units on a scale | Standard Error 5.5 |
Comparison: In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.p-value: <0.05Repeated Measure ANOVA
Secondary
Changes in Motor Neurodevelopmental Outcome
Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.
Time frame: Baseline - 1 month - 3 months - 6 months
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 1 month - Baseline | 5.0 units on a scale | Standard Error 1.5 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 3 months - 1 month | 4.5 units on a scale | Standard Error 1 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 6 months - Baseline | 11.7 units on a scale | Standard Error 2 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: Baseline | 45.2 units on a scale | Standard Error 4.7 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 6 months - 3 months | 2.2 units on a scale | Standard Error 0.6 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 6 months - 1 month | 6.7 units on a scale | Standard Error 1.3 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 3 months - Baseline | 9.5 units on a scale | Standard Error 1.9 |
| Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 6 months - Baseline | 7.6 units on a scale | Standard Error 2.2 |
| Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: Baseline | 53.3 units on a scale | Standard Error 5 |
| Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 1 month - Baseline | 5.2 units on a scale | Standard Error 2.1 |
| Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 3 months - Baseline | 6.8 units on a scale | Standard Error 2.1 |
| Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 3 months - 1 month | 1.6 units on a scale | Standard Error 0.5 |
| Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 6 months - 1 month | 2.5 units on a scale | Standard Error 0.6 |
| Erythropoietin & Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 6 months - 3 months | 0.9 units on a scale | Standard Error 0.4 |
| Only Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 3 months - 1 month | 1.5 units on a scale | Standard Error 0.4 |
| Only Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 1 month - Baseline | 2.7 units on a scale | Standard Error 0.6 |
| Only Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 6 months - 3 months | 1.0 units on a scale | Standard Error 0.4 |
| Only Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 6 months - 1 month | 2.5 units on a scale | Standard Error 0.5 |
| Only Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 6 months - Baseline | 5.2 units on a scale | Standard Error 0.9 |
| Only Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: 3 months - Baseline | 4.3 units on a scale | Standard Error 0.8 |
| Only Rehabilitation | Changes in Motor Neurodevelopmental Outcome | BSID-II Motor Scale: Baseline | 45.5 units on a scale | Standard Error 4.6 |
Comparison: The null hypothesis is that in terms of K-BSID-II MOTOR Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.p-value: <0.05Repeated Measure ANOVA
Secondary
Changes in Muscle Strength
Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 \ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point.
Time frame: Baseline - 1 month - 3 months - 6 months
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Muscle Strength | Baseline | 100.7 units on a scale | Standard Error 5.5 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Muscle Strength | 1 month | 105.0 units on a scale | Standard Error 4.9 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Muscle Strength | 3 months | 107.8 units on a scale | Standard Error 4.4 |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Changes in Muscle Strength | 6 months | 109.9 units on a scale | Standard Error 4.6 |
| Erythropoietin & Rehabilitation | Changes in Muscle Strength | 6 months | 109.3 units on a scale | Standard Error 4.5 |
| Erythropoietin & Rehabilitation | Changes in Muscle Strength | Baseline | 104.8 units on a scale | Standard Error 4.4 |
| Erythropoietin & Rehabilitation | Changes in Muscle Strength | 3 months | 107.7 units on a scale | Standard Error 4.5 |
| Erythropoietin & Rehabilitation | Changes in Muscle Strength | 1 month | 106.8 units on a scale | Standard Error 4.5 |
| Only Rehabilitation | Changes in Muscle Strength | 6 months | 104.3 units on a scale | Standard Error 4.6 |
| Only Rehabilitation | Changes in Muscle Strength | 1 month | 101.8 units on a scale | Standard Error 4.6 |
| Only Rehabilitation | Changes in Muscle Strength | 3 months | 103.6 units on a scale | Standard Error 4.6 |
| Only Rehabilitation | Changes in Muscle Strength | Baseline | 100.3 units on a scale | Standard Error 4.6 |
Comparison: In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.p-value: <0.05Repeated Measure ANOVA
Secondary
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that 1 refers to INCREASED areas, -1, DECREASED areas and 0, just NO CHANGE.
Time frame: Baseline - 2 weeks
Population: Intention to treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Lentiform Nucleus, Putamen | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Lentiform Nucleus, Gray Matter, Putamen | 1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Limbic Lobe, Parahippocampal Gyrus | -1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Frontal Lobe, Precentral Gyrus | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt.Lentiform Nucleus, Gray Matter, Globus Pallidus | 1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Temporal Lobe, Fusiform Gyrus | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Limbic Lobe, Anterior Cingulate | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Midbrain (Thalamus) | 1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt Cerebellum, Anterior Lobe, Culmen, Occipital | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Paracentral Lobule | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Parietal Lobe, Precuneus | 1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Limbic Lobe, Parahippocampal Gyrus | -1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Parietal Lobe, Pre- and Post-central Gyrus | 1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Temporal Lobe, Middle Temporal Gyrus | 1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Temporal Lobe, Inferior Temporal Gyrus | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Middle Frontal Gyrus | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Occipital Lobe, Middle Occipital Gyrus | -1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Temporal Lobe, Middle Temporal Gyrus | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Frontal Lobe, Middle Frontal Gyrus | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Orbital Gyrus | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Lentiform Nucleus, Gray Matter, Putamen | 1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt Cerebellum, Posterior Lobe, Declive | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Cerebellar Posterior Lobe, Cerebellar Tonsil | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Frontal Lobe, Medial Frontal Gyrus | 1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Sub-gyral | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Cerebellar Anterior Lobe, Culmen | 0 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Sub-lobar, Insula | 1 units on a scale |
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt Cerebellum, Posterior Lobe, Declive, Occipital | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Cerebellar Posterior Lobe, Cerebellar Tonsil | 1 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Frontal Lobe, Middle Frontal Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Middle Frontal Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Sub-gyral | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Temporal Lobe, Fusiform Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Temporal Lobe, Inferior Temporal Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Temporal Lobe, Middle Temporal Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Lentiform Nucleus, Gray Matter, Putamen | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Frontal Lobe, Medial Frontal Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Sub-lobar, Insula | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Lentiform Nucleus, Gray Matter, Putamen | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt.Lentiform Nucleus, Gray Matter, Globus Pallidus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Midbrain (Thalamus) | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Parietal Lobe, Precuneus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Temporal Lobe, Middle Temporal Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Parietal Lobe, Pre- and Post-central Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Paracentral Lobule | 1 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Limbic Lobe, Anterior Cingulate | 1 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Frontal Lobe, Precentral Gyrus | 1 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Lentiform Nucleus, Putamen | 1 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Cerebellar Anterior Lobe, Culmen | 1 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt Cerebellum, Posterior Lobe, Declive, Occipital | -1 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Orbital Gyrus | 1 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Occipital Lobe, Middle Occipital Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Limbic Lobe, Parahippocampal Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Limbic Lobe, Parahippocampal Gyrus | 0 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt Cerebellum, Posterior Lobe, Declive | -1 units on a scale |
| Erythropoietin & Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt Cerebellum, Anterior Lobe, Culmen, Occipital | -1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Sub-lobar, Insula | -1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt Cerebellum, Posterior Lobe, Declive, Occipital | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Lentiform Nucleus, Putamen | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Frontal Lobe, Medial Frontal Gyrus | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Limbic Lobe, Parahippocampal Gyrus | -1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Cerebellar Anterior Lobe, Culmen | 1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Lentiform Nucleus, Gray Matter, Putamen | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Middle Frontal Gyrus | -1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Cerebellar Posterior Lobe, Cerebellar Tonsil | 1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Temporal Lobe, Middle Temporal Gyrus | -1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt Cerebellum, Anterior Lobe, Culmen, Occipital | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Orbital Gyrus | 1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Temporal Lobe, Inferior Temporal Gyrus | -1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt Cerebellum, Posterior Lobe, Declive | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Occipital Lobe, Middle Occipital Gyrus | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Temporal Lobe, Middle Temporal Gyrus | -1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Parietal Lobe, Precuneus | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Temporal Lobe, Fusiform Gyrus | -1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Parietal Lobe, Pre- and Post-central Gyrus | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Midbrain (Thalamus) | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Frontal Lobe, Middle Frontal Gyrus | -1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Paracentral Lobule | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt.Lentiform Nucleus, Gray Matter, Globus Pallidus | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Limbic Lobe, Parahippocampal Gyrus | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Limbic Lobe, Anterior Cingulate | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Lentiform Nucleus, Gray Matter, Putamen | 0 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Rt. Frontal Lobe, Sub-gyral | -1 units on a scale |
| Only Rehabilitation | Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism | Lt. Frontal Lobe, Precentral Gyrus | 0 units on a scale |
Comparison: In our analysis, the null hypothesis is that the effects of three experimental groups are same each other, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) has much higher than that of either Erythropoietin + Rehabilitation Group or Rehabilitation Group. This study is a pilot study and therefore, power calculation was not applicable in our study. The sample size of each group is more than 30.p-value: 0.05t-test, 2 sided
Secondary
Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant
The number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Umbilical Cord Blood & Erythropoietin & Rehabilitation | Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant | 3 participants |
| Erythropoietin & Rehabilitation | Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant | 3 participants |
| Only Rehabilitation | Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant | 3 participants |
p-value: <0.05Fisher Exact