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临床试验 NCT07325981 针对脑瘫目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adherence, and Engagement in Children With Cerebral Palsy: A RCT 90 随机化 儿科
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临床试验NCT07325981是一项针对脑瘫的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2025年12月15日开始，预计招募90名患者。该研究由Ziauddin University主导，计划于2026年8月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年1月8日。
简要概括
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 motiv...显示更多
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 ...显示更多
官方标题
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
疾病
脑瘫其他研究标识符
- 11120925SIPT
NCT编号
实际开始日期
2025-12-15
最近更新发布
2026-01-08
预计完成日期
2026-08-01
计划入组人数
90
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
cerebral palsy, exergaming, bio-feedback, GMFCS, traditional physical therapy
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性exergaming The exergaming program will use Kinect Adventures (River Rush, Reflex Ridge) to train balance, agility, and trunk control; Kinect Sports to improve lower-limb activation, hand-eye coordination, and bilateral movements; Just Dance Kids for rhythmic stepping; and Kinect Party/Happy Action Theater to encourage free movement. Optional MIRA Rehab modules may target posture and agility. Sessions will be held three times pe...显示更多 | 运动游戏 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-...显示更多 |
实验性biofeedback-enhanced exergaming This group will perform the same exergaming activities as the exergaming group, with the added integration of real-time multimodal biofeedback to enhance motor learning. The frequency and duration of sessions will be identical to the exergaming group. Participants will receive on-screen visual guides that indicate whether their movements are being performed correctly, along with auditory feedback through performance-...显示更多 | 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. |
阳性对照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...显示更多 | 传统物理治疗 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...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Gross Motor Function Improvement | 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. | 4-6 months |
Balance Performance | 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. | 4-6 months |
Postural Control | 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. | 4-6 months |
Functional Mobility | 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. | 4-6 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Muscle Activation Patterns | Outcome Measure Title:
Surface electromyography (sEMG) amplitude and activation timing during task performance
Description:
Surface EMG will be used to record muscle activation amplitude and timing during functional tasks. Outcome variables will include normalized EMG amplitude and coordination patterns across target muscle groups.
Measurement units: Microvolts (µV), normalized activation ratios Interpretation: More efficient and coordinated activation patterns indicate improved motor control. | 4-6 months |
Game performance score | Score range: System-generated scores Interpretation: Higher game scores indicate improved motor learning and performance. | 4-6 months |
task completion time during virtual-based tasks | Description:
Motor learning including task completion time generated by the virtual rehabilitation system.
Interpretation: reduced completion times indicate improved motor learning and performance. | 4-6 months |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
6 Years
适龄性别
全部
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.
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).
Ziauddin University研究责任方
Sajid Iqbal, 主要研究者, Assistant Professor/Physical Therapist, Ziauddin University
研究中心联系人
联系人: Sajid Iqbal Khan, P.hD*, +923322380904, [email protected]
联系人: Dr. Amna Aamir khan, P.hD., +92324249814, [email protected]
1 位于 1 个国家/地区的研究中心
Sindh
Ziauddin University, Karachi, Sindh, 75850, Pakistan
Associate Professor/ Post Graduate Director FAHS, PhD, 联系人, +92 324 2497814, [email protected]