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

NCT06272760 | Completed

• 1 other identifier: 2024-02-060
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; Physical activity; Telerehabilitation; Accelerometer

Outcome Measures

Primary Outcomes (1)

• Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0).

  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 1 month (post intervention)

Secondary Outcomes (7)

• Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0).

  Baseline and 1 month (post intervention)

• Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0).

  Baseline and 1 month (post intervention)

• Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0).

  Baseline and 1 month (post intervention)

• Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at post-intervention test (T1-T0).

  Baseline and 1 month (post intervention)

• Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0).

  Baseline and 1 month (post intervention)

Study Arms (2)

Tele-HABIT

EXPERIMENTAL

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.

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

Control

NO INTERVENTION

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.

Interventions

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

Tele-HABIT

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• JEONG-YI KWON, MD, PHD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: December 1, 2024
• Primary Completion: February 20, 2026
• Study Completion: February 28, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-03

Locations

KR (1)