An interventional study of Constraint-induced movement therapy in Cerebral Palsy Spastic Hemiplegic, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 7 Months to 36 Months. Per ClinicalTrials.gov, last updated 2020-07-28.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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)
Other: Constraint-induced movement therapy
Children in control group will receive only traditional rehab therapies without wearing splint
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.
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
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
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
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
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
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
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
| Milestone | Constraint-induced Movement Therapy | Control |
|---|---|---|
| Started | 16 | 16 |
| Completed | 12 | 12 |
| Not completed | 4 | 4 |
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).
| score on a scale | Constraint-induced Movement Therapy | Control |
|---|---|---|
| how well | 0.83 ± 0.58 | 0.00 ± 0.57 |
| how often | 0.50 ± 0.35 | -0.05 ± 0.56 |
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.
| counts per minute | Constraint-induced Movement Therapy | Control |
|---|---|---|
| Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test | 44.73 ± 12.8 | 8.78 ± 14.94 |
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.
| score on a scale | Constraint-induced Movement Therapy | Control |
|---|---|---|
| self-care | 2.25 ± 2.30 | 1.25 ± 1.48 |
| mobility | 2.83 ± 1.64 | 2.83 ± 4.67 |
| social function | 2.83 ± 3.27 | 0.75 ± 0.75 |
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.
| score on a scale | Constraint-induced Movement Therapy | Control |
|---|---|---|
| grasping | 0.83 ± 1.80 | -0.83 ± 2.89 |
| visual motor integration | 0.92 ± 1.24 | -0.67 ± 1.61 |
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.
| score on a scale | Constraint-induced Movement Therapy | Control |
|---|---|---|
| Change From Baseline Gross Motor Function Measure (GMFM) at Post Test | 3.33 ± 2.55 | 4.37 ± 2.37 |
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.
| percentage of moderate to vigorous PA | Constraint-induced Movement Therapy | Control |
|---|---|---|
| Change From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Test | -2.67 ± 0.91 | 0.51 ± 1.31 |
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).
| Ratio | Constraint-induced Movement Therapy | Control |
|---|---|---|
| Change From Baseline Accelerometers_Use Ratio at Post Test | 0.01 ± 0.01 | -0.02 ± 0.07 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Constraint-induced Movement Therapy | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Control | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Constraint-induced Movement Therapy | Control | Total |
|---|---|---|---|
| <=18 years | 12 | 12 | 24 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(months) | Constraint-induced Movement Therapy | Control | Total |
|---|---|---|---|
| Mean | 15.9 ± 8.4 | 17.3 ± 6.2 | 16.6 ± 7.2 |
| Sex: Female, Male(Participants) | Constraint-induced Movement Therapy | Control | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 5 | 5 | 10 |
| Race (NIH/OMB)(Participants) | Constraint-induced Movement Therapy | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 12 | 12 | 24 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Constraint-induced Movement Therapy | Control | Total |
|---|---|---|---|
| South Korea | 12 | 12 | 24 |
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