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임상시험 NCT07325981은(는) 뇌성마비에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
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 무작위 배정 소아
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07325981은(는) 뇌성마비에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2025년 12월 15일부터 참여 신청이 가능합니다. 90명의 참여자를 모집할 예정입니다. Ziauddin University이(가) 진행하는 이 연구는 2026년 8월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 1월 8일에 갱신되었습니다.
간단한 개요
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...더 보기
상세한 설명
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 ...더 보기
공식 제목
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
질환명
뇌성마비기타 연구 식별자
- 11120925SIPT
NCT 번호
실제 연구 시작일
2025-12-15
최신 업데이트 게시
2026-01-08
예상 연구 완료일
2026-08-01
계획된 등록 인원
90
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
cerebral palsy, exergaming, bio-feedback, GMFCS, traditional physical therapy
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적exergaming 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...더 보기 | 운동 게임 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-...더 보기 |
실험적biofeedback-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-...더 보기 | 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. |
활성 대조군traditional 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...더 보기 | 전통적인 물리 치료 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...더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
어린이
최소 연령
6 Years
참여 가능한 성별
전체
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 University연구 책임자
Sajid Iqbal, 책임연구자, Assistant Professor/Physical Therapist, Ziauddin University
연구 대표 연락처
연락처: Sajid Iqbal Khan, P.hD*, +923322380904, [email protected]
연락처: Dr. Amna Aamir khan, P.hD., +92324249814, [email protected]
1 1개국에 임상시험 장소
Sindh
Ziauddin University, Karachi, Sindh, 75850, Pakistan
Associate Professor/ Post Graduate Director FAHS, PhD, 연락처, +92 324 2497814, [email protected]