Effects of Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy in Children With Unilateral Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy, Spastic Hemiplegic
• Interventions: Other: CIMT; Other: H-HABIT

• Registration Number: NCT04904796
• Lead Sponsor: Samsung Medical Center

Brief Summary

This study evaluates the therapeutic effects of constraint-induced movement therapy (CIMT) with home-based hand-arm bimanual intensive therapy (H-HABIT) with unilateral cerebral palsy. Half of the participants will receive CIMT and H-HABIT and others will only receive CIMT.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-21
• Study First Submitted: 2021-05-23
• Study First Submitted QC: 2021-05-23
• Study First Posted: 2021-05-27
• Primary Completion: 2023-06-20
• Study Completion: 2023-08-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Age 4 to 12 years
• MACS level 1-3
• Diagnosed with unilateral CP due to central nervous system lesions

Exclusion Criteria

• Severe cognitive dysfunction that rendered them unable to perform simple tasks (e.g., reaching, grasping
• Untreated seizures
• Visual or auditory problems interfering with treatment
• Prior history of musculoskeletal disorders.
• MACS level 4-5

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy	H-HABIT	Children in experimental group will receive 2-hour clinic-based CIMT sessions, 5 days/week for 3 weeks (30 hours), and 2-hour home-based HABIT sessions, 3 days/week for 5 weeks (30 hours).
Constraint-induced Movement Therapy only	CIMT	Children in experimental group will receive 2-hour clinic-based CIMT sessions, 5 days/week for 3 weeks (30 hours).
Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy	CIMT	Children in experimental group will receive 2-hour clinic-based CIMT sessions, 5 days/week for 3 weeks (30 hours), and 2-hour home-based HABIT sessions, 3 days/week for 5 weeks (30 hours).

Primary Outcome Measures

Name	Time	Method
Change from Assisting Hand Assessment (AHA) score at 2-month follow-up test	baseline and 2 months	AHA is a standardized tool for children(18 months-12 years) with unilateral CP. The AHA measures the child's ability to use the affected hand to assist the unaffected hand in a variety of bimanual activities. The 15-20 minute session uses semi-structured play with specific items. A certified AHA assessor views the videorecording to score the child's displayed willingness and ability to use the weaker arm and hand on each of 22 items from 1 (= does not do) to 4 (= effective). The AHA has inter- and intra-rater reliabilities of 0.98 and 0.97 respectively and content validity established during initial development. For data analysis, we generated AHA Logit scores (as recommended in the administration manual) that transform the raw (ordinal) scores into interval level data.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Melbourne Assessment 2 (MA2) score at 2-month follow-up test	baseline and 2 months	The Melbourne Assessment 2 (MA2) is a specific upper limb assessment focusing on the capacity of one hand. It benchmarks against certain criteria, delving into facets like movement range, accuracy, agility, and flow. The test was videotaped for analysis, and the raw score converted to a percentage of the maximal score.The higher the score, the better the motor function is interpreted. Test-retest results revealed moderate to high intrarater reliability for item totals (mean of 0.83 and 0.79) for each rater and high reliability for test totals (0.98 and 0.97).
Change from Canadian Occupational Performance Measure (COPM) score at 2-month follow-up test	baseline and 2 months	The COPM was designed as an outcome measure with a semi-structured interview format and structured scoring method to assess a person's level of self-efficacy. It conceptualizes self-efficacy in terms of self-perception of performance and satisfaction with performance. The COPM uses three 10-point rating scales to rate importance, performance and satisfaction. A score value of '1' refers to a low rating (i.e. 'not important at all', not able to do it at all', 'not satisfied at all'). A score value of '10' refers to a high rating (i.e. 'extremely important', 'able to do it extremely well', 'extremely satisfied'). Summing the ratings across problems and dividing by the total number of problems derive separate total performance and satisfaction scores.
Change from baseline Bilateral magnitude(Accelerometer) at 2-month follow-up test	baseline and 2 months	The bilateral magnitude is used to compare the overall movement of both arms together as a measure of bilateral arm movement: nonparetic magnitude + paretic magnitude. As with the magnitude ratio, the vector magnitude of the activity counts will be calculated for each epoch. A greater bilateral magnitude indicates greater overall movement of both arms.
Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at 2-month follow-up test	baseline and 2 months	The Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) was developed to respond to the need for an accurate and efficient functional measure with content for children and youth in multiple functional content areas. The new PEDI-CAT measures function in the three domains of Daily Activities, Mobility and Social/Cognitive for infants, children and youth from birth through 20 years of age. In addition, the PEDI-CAT's Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex, multi-step life tasks. The higher the score, the better the functional ability is interpreted.
Change from baseline Magnitude ratio(Accelerometer) at 2-month follow-up test	baseline and 2 months	The magnitude ratio is calculated as a metric to compare the magnitude of acceleration of the arms at each time point: ln(paretic magnitude/nonparetic magnitude). The magnitude will be calculated by taking the vector magnitude of the activity counts for each epoch. The natural log will be used to avoid skewness in the ratio caused by an underestimation of the denominator. The average magnitude will be calculated for each period. A magnitude ratio near 0 indicates similar use of each arm, a negative number indicates more use of the nonparetic arm, and a positive number indicates more use of the paretic arm.
Change from Baseline Pediatric Motor Activity Log (PMAL) score at 2-month follow-up test	baseline and 2 months	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).
Change from baseline Use ratio(Accelerometer) at 2-month follow-up test	baseline and 2 months	Use ratio provides a measurement that lets one compare the frequency of activity between the paretic and nonparetic arms: hours of paretic hand use/hours of nonparetic hand use. A use ratio equal to 1 indicates that the paretic and nonparetic arms are used an equal amount of time throughout the day, and values \>1 indicates greater use of the paretic arm. To calculate hours of arm movement, the number of epochs with activity counts \>0 will be summed and converted to hours for each arm.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of