Cerebral Palsy Spastic Hemiplegic Clinical Trial
Official title:
Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy
| Verified date | July 2020 |
| Source | Samsung Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | September 28, 2019 |
| Est. primary completion date | September 28, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 7 Months to 36 Months |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Samsung Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 a=0.88 to 0.95). | baseline and 4 weeks | |
| 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. | baseline and 4 weeks | |
| 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. | baseline and 4 weeks | |
| 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. | baseline and 4 weeks | |
| 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. | baseline and 4 weeks | |
| 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. | baseline and 4 weeks | |
| 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). | baseline and 4 weeks |