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

NCT04904796 | Completed

• 1 other identifier: SMC 2021-04-042
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic Hemiplegic

Keywords

Constraint-Induced Movement Therapy; Home-based Hand-arm Bimanual Intensive Therapy; Unilateral Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Change from Assisting Hand Assessment (AHA) score at 2-month follow-up test

  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.

  baseline and 2 months

Secondary Outcomes (7)

• Change from Baseline Pediatric Motor Activity Log (PMAL) score at 2-month follow-up test

  baseline and 2 months

• Change from Baseline Melbourne Assessment 2 (MA2) score at 2-month follow-up test

  baseline and 2 months

• Change from Canadian Occupational Performance Measure (COPM) score at 2-month follow-up test

  baseline and 2 months

• Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at 2-month follow-up test

  baseline and 2 months

• Change from baseline Use ratio(Accelerometer) at 2-month follow-up test

  baseline and 2 months

Study Arms (2)

Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy

EXPERIMENTAL

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).

Other: CIMT; Other: H-HABIT

Constraint-induced Movement Therapy only

ACTIVE COMPARATOR

Children in experimental group will receive 2-hour clinic-based CIMT sessions, 5 days/week for 3 weeks (30 hours).

Other: CIMT

Interventions

CIMT OTHER

CIMT : Constraint-Induced Movement Therapy (CIMT) is a deviation from traditional treatments, used to treat hemiplegia. Its aim is to stimulate the functional use of the affected limb and reverse the process developmental is disregard. In this method, the unaffected or less affected limb is restrained, so the person has to use the affected limb.

Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy; Constraint-induced Movement Therapy only

H-HABIT OTHER

H-HABIT : Hand-Arm Bimanual Intensive Therapy (HABIT) in children with hemiplegia is a new intervention developed at Columbia University. HABIT aims to improve the use and coordination of both arms in daily function. Unlike CIMT, HABIT focuses on improving the ability to perform bimanual activities. Participants will be monitored via webcam-based software (i.e. ZOOM) while they performed the activities in their own home.

Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

• Hwang Y, Kwon JY. Identifying the most representative actigraphy variables reflecting standardized hand function assessments for remote monitoring in children with unilateral cerebral palsy. BMC Pediatr. 2024 Apr 25;24(1):273. doi: 10.1186/s12887-024-04724-z.

  PMID: 38664706 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: May 27, 2021
• Study Start: May 21, 2021
• Primary Completion: June 20, 2023
• Study Completion: August 20, 2023
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

KR (1)