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

NCT ID: NCT04904796

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2023-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy, Spastic Hemiplegic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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).

Group Type EXPERIMENTAL

CIMT

Intervention Type 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.

H-HABIT

Intervention Type 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 only

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

Group Type ACTIVE_COMPARATOR

CIMT

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CIMT

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.

Intervention Type OTHER

H-HABIT

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jeong Yi Kwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38664706 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SMC 2021-04-042

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.