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

Development and Validation of a Remote Therapy Protocol Using Multimodal Sensor Fusion for Upper Limb Function Enhancement in Children With Cerebral Palsy

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Home-based hand-arm bimanual intensive training (Tele-HABIT)

Detailed Description

• 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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0).	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).	Baseline and 1 month (post intervention)
Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0).	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).	Baseline and 1 month (post intervention)
Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0).	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.	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).	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.	Baseline and 1 month (post intervention)
Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0).	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.	Baseline and 1 month (post intervention)
Change from baseline Bilateral magnitude(Accelerometer) at post-intervention test (T1-T0).	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.	Baseline and 1 month (post intervention)
Quantitative Analysis of Ocular Motor Function Using a Wearable Eye-Tracking Device (Neon)	This outcome assesses ocular motor function through the use of a wearable eye-tracking device (Neon; Pupil Labs GmbH, Germany). The Neon system records real-time eye movement parameters during standardized visual-perceptual and motor tasks without requiring calibration. Key variables include fixation duration, saccadic amplitude, pupil dilation, and gaze stability. Data will be used to identify oculomotor biomarkers that reflect potential deficits in visual-motor integration and central visual-vestibular processing in children with unilateral cerebral palsy. Eye-tracking recordings are synchronized with task performance and analyzed using validated software (Pupil Cloud). This objective measure is intended to complement clinical test scores and provide deeper insight into underlying sensorimotor integration difficulties.	Baseline and 1 month (post intervention)

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: JEONG-YI KWON, MD, PHD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): February 20, 2026
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Physical activity; Telerehabilitation; Cerebral palsy; Accelerometer
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Behavior; Cerebral Palsy; Motor Activity
• Other Study ID Numbers: 2024-02-060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No