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

Official title

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

Overview

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.

Detailed description

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).

Interventions

• Other exergaming
  The exergaming program will use Kinect Adventures (River Rush, Reflex Ridge) for balance and agility, Kinect Sports for lower-limb activation and coordination, Just Dance Kids for rhythmic stepping, and Kinect Party/Happy Action Theater for free movement. Optional MIRA Rehab modules may target posture and agility. Sessions will occur three times weekly for twelve weeks, beginning with a light warm-up, followed by 20-30 minutes of targeted exergames, and ending with a cool-down. Game difficulty w
• Other biofeedback-enhanced exergaming
  This group will perform the same exergames as Intervention 1 but with real-time visual, auditory, and optional vibration feedback to enhance motor learning. Surface EMG (Delsys Trigno) will record bilateral muscle activity, and Microsoft Kinect SDK (v2/Azure) will track joint motion and posture. Session frequency and duration will be identical.
• Other Traditional Physical Therapy
  Children in this group will receive standard physical therapy to improve gross motor function, especially balance and mobility. Sessions will be held three times per week for twelve weeks, lasting 30-45 minutes. The protocol includes a 5-minute warm-up, 12-15 minutes of strengthening for hip, knee, and ankle muscles, 8-10 minutes of balance training using wobble boards or foam, and 8-10 minutes of functional mobility tasks such as sit-to-stand and stair practice, followed by a 2-5 minute cool-do

Primary outcome measures

• Gross Motor Function Improvement [Time frame: 4-6 months]
• Balance Performance [Time frame: 4-6 months]
• Postural Control [Time frame: 4-6 months]
• Functional Mobility [Time frame: 4-6 months]

Secondary outcome measures (3)

• Muscle Activation Patterns [Time frame: 4-6 months]
• Game performance score [Time frame: 4-6 months]
• task completion time during virtual-based tasks [Time frame: 4-6 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Ziauddin University — Karachi

Identifiers

NCT: NCT07325981 · 11120925SIPT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗