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

This single-blinded randomized controlled trial will be conducted at Ziauddin Hospital and the IHRI Rehabilitation Centre and School, Karachi, Pakistan. A total of 90 children (aged 6-12 years) with spastic diplegic or hemiplegic cerebral palsy (GMFCS levels I-II) will be recruited through purposive sampling and stratified by age band (6-8 vs. 9-12 years) and GMFCS level. Participants will be randomized (1:1:1) into three intervention groups using computer-generated permuted blocks with allocation concealment via sealed envelopes.

Outcome assessors and data analysts will be blinded. Inclusion requires adequate cognition (NIH Toolbox PSMT ≥ 25th percentile), functional mobility, and hearing/vision sufficient for exergaming tasks. Exclusion criteria include severe motor, cognitive, or sensory impairments, uncontrolled epilepsy, behavioral challenges, or concurrent clinical trial participation. The sample size (n=90) was determined via G*Power (effect size f=0.30, α=0.05, power=0.80) to detect clinically meaningful between-group differences in motor function (BOT-2).

Inclusion criteria

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 criteria

• 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).