Children With Spastic Diplegia, Between the Ages of 2 to 10 Years, Gross Motor Function Classification System (GMFCS) Level I,II and III
Conditions
Keywords
Children with cerebral palsy, Gross Motor Function Measure, Imitative learning, Mirror neuron, Action observation, Conventional physical therapy
Brief summary
This study aimed to develop Video Compact Disc (VCD) program that applying the concept of imitative learning with mirror neurons stimulation on standard rehabilitation technique in children with cerebral palsy. The author will also examine effectiveness of the program by compare the motor function measured by the gross motor function measure (GMFM-66) between conventional physical therapy and the mirror neurons stimulation based VCD program for six months.
Detailed description
A randomized controlled trial was performed with thirty children with cerebral palsy recruited from Thammasat University Hospital and Rajanukul institute. Informed consent was obtained from the participants' parents before participation in this study. The participants were randomly assigned according to the randomization list to receive either the mirror neurons stimulation based VCD program and practice at home or conventional physical therapy for six months. The participants in the experiment group received the mirror neurons stimulation based VCD program and practice at home three times a day for six months. Concerning the control group, the participants received conventional physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. Both experimental and control groups were measured their motor functions with gross motor function measure (GMFM-66).
Interventions
PROCEDUREThe mirror neurons stimulation based VCD program
The children receive the mirror neurons stimulation based VCD program and practice at home three times a day for six months.
PROCEDUREThe conventional physical therapy
The children were randomly assigned to receive the conventional physical therapy for six months. Both experimental and control groups were measured their motor functions with GMFM-66 by an independent pediatric physical therapist who was blinded for treatment allocation at entry, the second month and the sixth month.
Sponsors
National Research Council of Thailand
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Children with cerebral palsy aged between 2-10 years old * GMFCS level of one to three * Able to verbal instruction * Sitting are performed without assistance * Standing and walking are performed with adult assistance * No severe limitation of joint movement
Exclusion criteria
* The children were received orthopedic intervention or botulinum toxin injection within 6 months * Seizure * Other conditions that prevent children from participate in research project * Severe visual and hearing deficits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. | Base line, two months and six months | The mean total score of GMFM-66 of each group at entry, the second and the sixth month. The GMFM-66 contains five dimensions of motor measure including lying/rolling (4 items), sitting (15 items), crawling/kneeling (10 items), standing (13 items), and walking/running/jumping (24 items). The GMFM-66 are scored on a 4-point ordinal scale 0=does not initiate, 1=initiates \< 10% of activity,2=partially completes 10% to \< 100% of activity,3=completes activity). The scores were converted to a continuous scale by using the Winsteps Rasch Software.The GMFM-66 score is an interval-level measure of function where subjects are placed on an ability continuum ranging from 0 (low motor ability) to 100 (high motor ability). GMFM-66 score less than 30 that are considered low gross motor skills. |
Countries
Thailand
Participant flow
Recruitment details
The children were recruited from Thammasat University hospital and Rajanukul institute. Study period was two years which started from September 2009 to October 2011.
Pre-assignment details
Thirty two children were assessed for their eligibility to participate in the study. One were excluded for failing to meet the inclusion criteria. One parent of a child refused to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| The Mirror Neurons Stimulation Based VCD Program The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects. | 15 |
| The Conventional Physical Therapy The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | The Mirror Neurons Stimulation Based VCD Program | The Conventional Physical Therapy | Total |
|---|---|---|---|
| Age, Continuous | 6.2 years STANDARD_DEVIATION 2.2 | 5.5 years STANDARD_DEVIATION 2.2 | 5.9 years STANDARD_DEVIATION 2.2 |
| Baseline Gross Motor Function Measure (GMFM-66) score | 44.8 Scores STANDARD_DEVIATION 14 | 49.4 Scores STANDARD_DEVIATION 13.1 | 47.1 Scores STANDARD_DEVIATION 13.5 |
| Region of Enrollment Thailand | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month.
The mean total score of GMFM-66 of each group at entry, the second and the sixth month. The GMFM-66 contains five dimensions of motor measure including lying/rolling (4 items), sitting (15 items), crawling/kneeling (10 items), standing (13 items), and walking/running/jumping (24 items). The GMFM-66 are scored on a 4-point ordinal scale 0=does not initiate, 1=initiates \< 10% of activity,2=partially completes 10% to \< 100% of activity,3=completes activity). The scores were converted to a continuous scale by using the Winsteps Rasch Software.The GMFM-66 score is an interval-level measure of function where subjects are placed on an ability continuum ranging from 0 (low motor ability) to 100 (high motor ability). GMFM-66 score less than 30 that are considered low gross motor skills.
Time frame: Base line, two months and six months
Population: A total of 30 children with cerebral palsy was followed and completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Mirror Neurons Stimulation Based VCD Program | The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. | The mean score of GMFM-66 at the entry | 44.8 Scores on a scale | Standard Deviation 14 |
| The Mirror Neurons Stimulation Based VCD Program | The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. | The mean score of GMFM-66 at the second month | 54.7 Scores on a scale | Standard Deviation 14.5 |
| The Mirror Neurons Stimulation Based VCD Program | The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. | The mean score of GMFM-66 at the sixth month | 57.8 Scores on a scale | Standard Deviation 13.9 |
| The Conventional Physical Therapy | The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. | The mean score of GMFM-66 at the entry | 49.4 Scores on a scale | Standard Deviation 13.1 |
| The Conventional Physical Therapy | The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. | The mean score of GMFM-66 at the second month | 57.5 Scores on a scale | Standard Deviation 16.2 |
| The Conventional Physical Therapy | The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. | The mean score of GMFM-66 at the sixth month | 63.2 Scores on a scale | Standard Deviation 16.8 |
Comparison: A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the second month compared to those in the control group after adjusted for the baseline level.p-value: 0.3495% CI: [-2.3, 6.5]ANCOVA
Comparison: A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the sixth month compared to those in the control group after adjusted for the baseline level.p-value: 0.7895% CI: [-6.3, 4.7]ANCOVA