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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Gross Motor Function Improvement
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors and data analysts will be blinded to group codes.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Gross Motor Function Improvement
时间窗: 4-6 months
Outcome Measure Title: Gross Motor Function Measure (GMFM-88) total score (%) Description: Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88), a standardized observational tool evaluating motor skills across five domains: lying \& rolling, sitting, crawling \& kneeling, standing, and walking/running/jumping. Scores are expressed as a percentage of the maximum possible score. Score range: 0-100% Interpretation: Higher scores indicate better gross motor function.
Balance Performance
时间窗: 4-6 months
Outcome Measure Title: Pediatric Balance Scale (PBS) total score Description: Balance performance will be measured using the Pediatric Balance Scale (PBS), a functional balance assessment adapted from the Berg Balance Scale. The scale consists of 14 tasks assessing static and dynamic balance during functional activities. Score range: 0-56 Interpretation: Higher scores indicate better balance performance.
Postural Control
时间窗: 4-6 months
Outcome Measure Title: Postural stability parameters derived from Kinect-based motion analysis Description: Postural control stability will be quantified using Kinect-based motion tracking, capturing center of mass displacement, joint angles, and sway during task-based activities. Movement stability indices (e.g., reduced sway amplitude and improved alignment) will be derived from kinematic data. Measurement units: Degrees (joint angles), millimeters (displacement), task-specific stability indices Interpretation: Lower sway and improved alignment indicate better postural stability.
Functional Mobility
时间窗: 4-6 months
Outcome Measure Title: Timed Up and Go (TUG) test duration (seconds) Description: Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time required to stand from a seated position, walk 3 meters, turn, return, and sit down. Score range: Continuous variable (seconds) Interpretation: Shorter completion times indicate better functional mobility.
Gross Motor Function Improvement
时间窗: 4-6 months
Outcome Measure Title: Gross Motor Function Measure (GMFM-88) total score (%) Description: Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88), a standardized observational tool evaluating motor skills across five domains: lying \& rolling, sitting, crawling \& kneeling, standing, and walking/running/jumping. Scores are expressed as a percentage of the maximum possible score. Score range: 0-100% Interpretation: Higher scores indicate better gross motor function.
Balance Performance
时间窗: 4-6 months
Outcome Measure Title: Pediatric Balance Scale (PBS) total score Description: Balance performance will be measured using the Pediatric Balance Scale (PBS), a functional balance assessment adapted from the Berg Balance Scale. The scale consists of 14 tasks assessing static and dynamic balance during functional activities. Score range: 0-56 Interpretation: Higher scores indicate better balance performance.
Postural Control
时间窗: 4-6 months
Outcome Measure Title: Postural stability parameters derived from Kinect-based motion analysis Description: Postural control stability will be quantified using Kinect-based motion tracking, capturing center of mass displacement, joint angles, and sway during task-based activities. Movement stability indices (e.g., reduced sway amplitude and improved alignment) will be derived from kinematic data. Measurement units: Degrees (joint angles), millimeters (displacement), task-specific stability indices Interpretation: Lower sway and improved alignment indicate better postural stability.
Functional Mobility
时间窗: 4-6 months
Outcome Measure Title: Timed Up and Go (TUG) test duration (seconds) Description: Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time required to stand from a seated position, walk 3 meters, turn, return, and sit down. Score range: Continuous variable (seconds) Interpretation: Shorter completion times indicate better functional mobility.
次要结局
- Muscle Activation Patterns(4-6 months)
- task completion time during virtual-based tasks(4-6 months)
- task completion time during virtual-based tasks(4-6 months)
- Game performance score(4-6 months)
- Muscle Activation Patterns(4-6 months)
研究者
Sajid Iqbal
Assistant Professor/Physical Therapist
Ziauddin University