Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adherence, and Engagement in Children With Cerebral Palsy: A RCT

Trial details

Who runs it

Ziauddin University

Trial code

NCT07325981

Record updated

8 January 2026

Original description

Cerebral Palsy (CP) accounts for approximately 0.9% of the global disease burden and affects 2.4-4% of children under 5 years old, with associated developmental and coordination impairments. Pediatric physical therapy aims to enhance independence and quality of life; however, maintaining adherence to conventional treatment remains a major challenge due to its repetitive and monotonous nature, leading to reduced motivation and limited functional progress.Read full original descriptionShow less

Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adherence, and Engagement in Children With Cerebral Palsy (GMFCS I-II): A Randomized Controlled Trial

Cerebral Palsy (CP) accounts for approximately 0.9% of the global disease burden and affects 2.4-4% of children under 5 years old, with associated developmental and coordination impairments. Pediatric physical therapy aims to enhance independence and quality of life; however, maintaining adherence to conventional treatment remains a major challenge due to its repetitive and monotonous nature, leading to reduced motivation and limited functional progress.

Exergaming, integrating physical activity with interactive video games, has emerged as an engaging alternative shown to improve motor function, balance, and coordination in children with motor impairments. While existing evidence supports its effectiveness, few randomized studies have explored the addition of real-time physiological biofeedback (e.g., surface EMG with motion tracking) within exergaming platforms. Evidence on adherence and engagement outcomes also remains limited.

This trial addresses that gap by investigating the combined effects of biofeedback-enhanced exergaming versus exergaming alone and traditional physiotherapy in children with CP (GMFCS levels I-II). Incorporating real-time biofeedback provides immediate physiological feedback, potentially enhancing motor learning, motivation, and adherence, key components for improving long-term rehabilitation outcomes in pediatric populations.

Inclusion: Diagnosed with Cerebral Palsy (CP), specifically spastic diplegia, spastic hemiplegia, or mild ataxia; Gross Motor Function Classification System (GMFCS) Level I or II; Male and female aged between 6 and 12 years at the time of enrollment; Manual Ability Classification System (MACS) Level I or II; Able to follow simple two-step commands, with or without augmentative and alternative communication (AAC); Demonstrates adequate cognitive functioning based on the NIH Toolbox Picture Sequence Memory Test (PSMT), scoring at or above the 25th percentile (T-score ≥ 40) based on age-adjusted norms; Hearing and vision adequate to participate in exergaming tasks (with or without assistive devices); Able to stand and participate in basic movements with or without minimal assistance; Willingness to participate and written informed consent from parent/guardian with assent from the child.

Exclusion: GMFCS Level III or higher, indicating significant gross motor limitations; MACS Level III or higher, indicating significant manual impairment; Severe uncorrected visual or hearing impairment that would interfere with interaction during exergaming; Uncontrolled epilepsy or other neurological condition contraindicating active movement; Significant behavioral or attention challenges that prevent engagement with game-based tasks; Score below the 25th percentile on the PSMT, indicating insufficient episodic memory to follow game tasks; Involvement in any other intervention trial that may interfere with study participation; Medical conditions that contraindicate participation in physical activity (as determined by a physician).

ClinicalTrials.gov NCT07325981