Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy Spastic Hemiplegic
- Sponsor
- Samsung Medical Center
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Jeong Yi Kwon
Professor
Samsung Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test
Time Frame: baseline and 4 weeks
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.
Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test
Time Frame: baseline and 4 weeks
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).
Secondary Outcomes
- Change From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Test(baseline and 4 weeks)
- Change From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Test(baseline and 4 weeks)
- Change From Baseline Accelerometers_Use Ratio at Post Test(baseline and 4 weeks)
- Change From Baseline Gross Motor Function Measure (GMFM) at Post Test(baseline and 4 weeks)
- Change From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Test(baseline and 4 weeks)