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Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy

Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03858335
Enrollment
32
Registered
2019-02-28
Start date
2015-09-14
Completion date
2019-09-28
Last updated
2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy Spastic Hemiplegic

Keywords

constraint-induced movement therapy, hemiplegia, hand function, gross motor

Brief summary

This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

Detailed description

This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not. Participants will be randomly assigned to either CIMT group or control group. Children of the CIMT group will wear forearm splint 24 hours for 3 weeks to inhibit use of the unaffected arm.

Interventions

The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Months to 36 Months
Healthy volunteers
No

Inclusion criteria

* spastic hemiplegic cerebral palsy patients * 7\ 36 months old

Exclusion criteria

* cognitive impairment severe enough to make participation impossible * uncontrolled epilepsy * visual or hearing impairment * musculoskeletal disorders

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Testbaseline and 4 weeksThe PMAL was derived from the Motor Activity Log, which is used as an assessment tool in adults who participated CIMT, to measure changes in upper extremity use in real life. This parental assessment tool rates the use of the children's affected upper extremities in daily activities. Twenty-two arm-hand functional tasks that are typical for children aged 7 months to 8 years (e.g., taking off socks or shoes, holding a cup) were assessed and collected as a systemic data. The test has two components: (1) how often (PMAL HO) and (2) how well (PMAL HW). Parents rate PMAL HO on a 6-point scale from 0 (not at all) to 5 (all the time) and PMAL HW from 0 (does not use) to 5 (same as the unaffected arm). This tool has a high test-retest reliability (r=0.94; P\<0.01) and a high internal consistency (Cronbach's α=0.88 to 0.95).
Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Testbaseline and 4 weeksTo evaluate the upper limb use in the real-world, participants wore two accelerometers (one on each wrist). Three variables were measured using accelerometers: vector magnitude average counts (VMA), percent of time in moderate to vigorous physical activity (% MVPA), and use ratio (UR). VMA refers to the magnitude of the resulting vector that forms when combining the sampled acceleration from all three axes.

Secondary

MeasureTime frameDescription
Change From Baseline Gross Motor Function Measure (GMFM) at Post Testbaseline and 4 weeksGMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. The score of each dimension is expressed as a percentage of the maximum score. The GMFM-66, which includes 66 items of the original 88 items. Item scoring is the same for the GMFM-88 and the GMFM-66. There is a scoring system with each item scored as 0, 1, 2, 3, or not tested. A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. Scoring the GMFM-66 requires the use of a computer program called the Gross Motor Ability Estimator (GMAE). Individual item scores are entered and a mathematical algorithm calculates an interval level total score. The total score is an estimate of the child's gross motor function. The range of total score is from 0 to 100. The higher values represent a better outcome.
Change From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Testbaseline and 4 weeksThe Pediatric Evaluation of Disability Inventory (PEDI) is a reliable and valid parent-report assessment that evaluates the performance, changes, and capabilities of functional activities in children with disabilities aged between 6 months and 7.5 years. Within the three domains of (1) self-care, (2) mobility, and (3) social function, it measures three scales: (1) functional skills; (2) caregiver assistance; and (3) modifications. In this study, only the functional skills scale was used because it directly evaluates the current capabilities of selected tasks. Therefore, the PEDI scores in this study reflect the functional skill of the children on a scale between 0 and 100: 0 indicates no ability, and 100 indicates full capability to perform the selected items.
Change From Baseline Accelerometers_Use Ratio at Post Testbaseline and 4 weeksUse Ratio was calculated by dividing the hours of use of the affected limb by the hours of use of the non-affected limb (affected use/unaffected use).
Change From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Testbaseline and 4 weeksMVPA is a category of activity intensity, which is measured with metabolic equivalents (METs). Moderate-intensity physical activity is defined as 3-6 METs, and vigorous-intensity physical activity is defined as any activity above 6 METs. This means that MVPA is any activity over 3 METs.
Change From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Testbaseline and 4 weeksThe PDMS-2 is a standardized, norm-referenced test, which includes gross motor and fine motor domains. All items of the PDMS-2 are scored on a 3-point scale (0 to 2): 0 is assigned when the child cannot perform the item or when the attempts do not meet the criteria of the item; 1 is assigned when the attempts do not meet for successful performance, but the behavior is emerging; and 2 indicates that the behavior is emerging, and the criterion for successful performance is fully met. The standard score and developmental age equivalent are obtained by converting the raw score of each subtest according to the criteria of the PDMS-2 manual; the standard score was used for this study. The interrater reliability and internal consistency of the fine motor domain were reported as 0.98 and 0.96, respectively. The predictive validity was reported as 0.91.

Countries

South Korea

Participant flow

Participants by arm

ArmCount
Constraint-induced Movement Therapy
Children in constraint-induced movement therapy (CIMT) group will wear forearm splint on the unaffected arm 24 hours for 3 weeks, and receive 15 mCIMT sessions(30-hour dosage) Constraint-induced movement therapy: The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks.
12
Control
Children in control group will receive only traditional rehab therapies without wearing splint
12
Total24

Baseline characteristics

CharacteristicControlTotalConstraint-induced Movement Therapy
Age, Categorical
<=18 years
12 Participants24 Participants12 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous17.3 months
STANDARD_DEVIATION 6.2
16.6 months
STANDARD_DEVIATION 7.2
15.9 months
STANDARD_DEVIATION 8.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
12 Participants24 Participants12 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
South Korea
12 participants24 participants12 participants
Sex: Female, Male
Female
7 Participants14 Participants7 Participants
Sex: Female, Male
Male
5 Participants10 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 12
other
Total, other adverse events
0 / 120 / 12
serious
Total, serious adverse events
0 / 120 / 12

Outcome results

Primary

Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test

To evaluate the upper limb use in the real-world, participants wore two accelerometers (one on each wrist). Three variables were measured using accelerometers: vector magnitude average counts (VMA), percent of time in moderate to vigorous physical activity (% MVPA), and use ratio (UR). VMA refers to the magnitude of the resulting vector that forms when combining the sampled acceleration from all three axes.

Time frame: baseline and 4 weeks

Population: Only children who agreed to participate in the accelerometer study(n=8) wore accelerometers.

ArmMeasureValue (MEAN)Dispersion
Constraint-induced Movement TherapyChange From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test44.73 counts per minuteStandard Deviation 12.8
ControlChange From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test8.78 counts per minuteStandard Deviation 14.94
Primary

Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test

The PMAL was derived from the Motor Activity Log, which is used as an assessment tool in adults who participated CIMT, to measure changes in upper extremity use in real life. This parental assessment tool rates the use of the children's affected upper extremities in daily activities. Twenty-two arm-hand functional tasks that are typical for children aged 7 months to 8 years (e.g., taking off socks or shoes, holding a cup) were assessed and collected as a systemic data. The test has two components: (1) how often (PMAL HO) and (2) how well (PMAL HW). Parents rate PMAL HO on a 6-point scale from 0 (not at all) to 5 (all the time) and PMAL HW from 0 (does not use) to 5 (same as the unaffected arm). This tool has a high test-retest reliability (r=0.94; P\<0.01) and a high internal consistency (Cronbach's α=0.88 to 0.95).

Time frame: baseline and 4 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Constraint-induced Movement TherapyChange From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Testhow well0.83 score on a scaleStandard Deviation 0.58
Constraint-induced Movement TherapyChange From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Testhow often0.50 score on a scaleStandard Deviation 0.35
ControlChange From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Testhow well0.00 score on a scaleStandard Deviation 0.57
ControlChange From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Testhow often-0.05 score on a scaleStandard Deviation 0.56
Secondary

Change From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Test

MVPA is a category of activity intensity, which is measured with metabolic equivalents (METs). Moderate-intensity physical activity is defined as 3-6 METs, and vigorous-intensity physical activity is defined as any activity above 6 METs. This means that MVPA is any activity over 3 METs.

Time frame: baseline and 4 weeks

Population: Only children who agreed to participate in the accelerometer study(n=8) wore accelerometers.

ArmMeasureValue (MEAN)Dispersion
Constraint-induced Movement TherapyChange From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Test-2.67 percentage of moderate to vigorous PAStandard Deviation 0.91
ControlChange From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Test0.51 percentage of moderate to vigorous PAStandard Deviation 1.31
Secondary

Change From Baseline Accelerometers_Use Ratio at Post Test

Use Ratio was calculated by dividing the hours of use of the affected limb by the hours of use of the non-affected limb (affected use/unaffected use).

Time frame: baseline and 4 weeks

Population: Only children who agreed to participate in the accelerometer study(n=8) wore accelerometers.

ArmMeasureValue (MEAN)Dispersion
Constraint-induced Movement TherapyChange From Baseline Accelerometers_Use Ratio at Post Test0.01 RatioStandard Deviation 0.01
ControlChange From Baseline Accelerometers_Use Ratio at Post Test-0.02 RatioStandard Deviation 0.07
Secondary

Change From Baseline Gross Motor Function Measure (GMFM) at Post Test

GMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. The score of each dimension is expressed as a percentage of the maximum score. The GMFM-66, which includes 66 items of the original 88 items. Item scoring is the same for the GMFM-88 and the GMFM-66. There is a scoring system with each item scored as 0, 1, 2, 3, or not tested. A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. Scoring the GMFM-66 requires the use of a computer program called the Gross Motor Ability Estimator (GMAE). Individual item scores are entered and a mathematical algorithm calculates an interval level total score. The total score is an estimate of the child's gross motor function. The range of total score is from 0 to 100. The higher values represent a better outcome.

Time frame: baseline and 4 weeks

ArmMeasureValue (MEAN)Dispersion
Constraint-induced Movement TherapyChange From Baseline Gross Motor Function Measure (GMFM) at Post Test3.33 score on a scaleStandard Deviation 2.55
ControlChange From Baseline Gross Motor Function Measure (GMFM) at Post Test4.37 score on a scaleStandard Deviation 2.37
Secondary

Change From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Test

The PDMS-2 is a standardized, norm-referenced test, which includes gross motor and fine motor domains. All items of the PDMS-2 are scored on a 3-point scale (0 to 2): 0 is assigned when the child cannot perform the item or when the attempts do not meet the criteria of the item; 1 is assigned when the attempts do not meet for successful performance, but the behavior is emerging; and 2 indicates that the behavior is emerging, and the criterion for successful performance is fully met. The standard score and developmental age equivalent are obtained by converting the raw score of each subtest according to the criteria of the PDMS-2 manual; the standard score was used for this study. The interrater reliability and internal consistency of the fine motor domain were reported as 0.98 and 0.96, respectively. The predictive validity was reported as 0.91.

Time frame: baseline and 4 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Constraint-induced Movement TherapyChange From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Testgrasping0.83 score on a scaleStandard Deviation 1.8
Constraint-induced Movement TherapyChange From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Testvisual motor integration0.92 score on a scaleStandard Deviation 1.24
ControlChange From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Testgrasping-0.83 score on a scaleStandard Deviation 2.89
ControlChange From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Testvisual motor integration-0.67 score on a scaleStandard Deviation 1.61
Secondary

Change From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Test

The Pediatric Evaluation of Disability Inventory (PEDI) is a reliable and valid parent-report assessment that evaluates the performance, changes, and capabilities of functional activities in children with disabilities aged between 6 months and 7.5 years. Within the three domains of (1) self-care, (2) mobility, and (3) social function, it measures three scales: (1) functional skills; (2) caregiver assistance; and (3) modifications. In this study, only the functional skills scale was used because it directly evaluates the current capabilities of selected tasks. Therefore, the PEDI scores in this study reflect the functional skill of the children on a scale between 0 and 100: 0 indicates no ability, and 100 indicates full capability to perform the selected items.

Time frame: baseline and 4 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Constraint-induced Movement TherapyChange From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Testself-care2.25 score on a scaleStandard Deviation 2.3
Constraint-induced Movement TherapyChange From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Testmobility2.83 score on a scaleStandard Deviation 1.64
Constraint-induced Movement TherapyChange From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Testsocial function2.83 score on a scaleStandard Deviation 3.27
ControlChange From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Testsocial function0.75 score on a scaleStandard Deviation 0.75
ControlChange From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Testself-care1.25 score on a scaleStandard Deviation 1.48
ControlChange From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Testmobility2.83 score on a scaleStandard Deviation 4.67

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026