Development of a Remote Therapy Protocol for Upper Limb Function Enhancement in Children With Cerebral Palsy

NCT ID: NCT06272760

Last Updated: 2025-04-04

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-02-28

Brief Summary

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The perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy.

Detailed Description

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* Development of a home-based remote upper limb function evaluation program using heterogeneous (multimodal) sensors.
* Development of a home-based remote upper limb function improvement treatment program using heterogeneous sensors.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single blinding

Study Groups

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Tele-HABIT

Children in the experimental group are going to receive intensive bimanual activity-based occupational therapy, known as Home-Based HABIT (H-HABIT). This therapy is going to be administered remotely. Each session will last for 2 hours and was conducted 5 times a week. The total duration of this intervention is 3 weeks.

Group Type EXPERIMENTAL

Home-based hand-arm bimanual intensive training (Tele-HABIT)

Intervention Type OTHER

Hand-Arm Bimanual Intensive Therapy (HABIT) is a therapeutic approach designed to improve the motor skills and functional use of both arms in individuals with conditions such as cerebral palsy. The core principle of HABIT is to encourage voluntary exercise by actively engaging the affected side, which may be weaker or partially paralyzed, in various activities. This approach aims to reduce physical and mental discomfort while maximizing the effectiveness of the training. HABIT has been adapted into a home-based format by ZOOM, referred to as Home-Based HABIT (H-HABIT).

Control

Children in the control group will not receive any intervention during the 3-week study period. They will be placed on a waitlist and offered the same therapy after the study is completed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home-based hand-arm bimanual intensive training (Tele-HABIT)

Hand-Arm Bimanual Intensive Therapy (HABIT) is a therapeutic approach designed to improve the motor skills and functional use of both arms in individuals with conditions such as cerebral palsy. The core principle of HABIT is to encourage voluntary exercise by actively engaging the affected side, which may be weaker or partially paralyzed, in various activities. This approach aims to reduce physical and mental discomfort while maximizing the effectiveness of the training. HABIT has been adapted into a home-based format by ZOOM, referred to as Home-Based HABIT (H-HABIT).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 6 to 12 years
* MACS level 1-4
* Diagnosed with CP due to central nervous system lesions

Exclusion Criteria

* Individuals with a Manual Ability Classification System (MACS) level V, indicating an inability to use both hands in daily life activities.
* Individuals who fall within levels 0 to 4 of the House Functional Classification System.
* Individuals with severe intellectual disabilities, characterized by difficulties in understanding or following instructions.
* Individuals with vision impairment that could affect participation in the therapy.
* Individuals who have received a botulinum toxin injection in the upper extremity within the past 6 months.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong Yi Kwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JEONG-YI KWON, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JEONG-YI KWON, MD, PHD

Role: CONTACT

+821045911039

Facility Contacts

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Youngsub Hwang, Ph.D.

Role: primary

+821065292034

Other Identifiers

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2024-02-060

Identifier Type: -

Identifier Source: org_study_id

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