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임상시험 NCT07061275은(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
Telehealth-Supervised Resistance Training for Children With Cerebral Palsy 50 원격 의료 소아
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임상시험 NCT07061275은(는) 뇌성마비에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 1월 1일부터 참여 신청이 가능합니다. 50명의 참여자를 모집할 예정입니다. Hunan Normal University이(가) 진행하는 이 연구는 2027년 3월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 15일에 갱신되었습니다.
간단한 개요
The goal of this clinical trial is to evaluate the feasibility and potential benefits of telehealth-supervised resistance training in ambulatory children aged 6 to 15 years with cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) levels I-III.
The main questions it aims to answer are:
- Is a 12-week telehealth-delivered resistance training program feasible and acceptable for childre...
상세한 설명
Cerebral palsy (CP) is a lifelong neurodevelopmental disorder caused by non-progressive disturbances in the developing fetal or infant brain. It is characterized by impairments in movement and posture, often accompanied by disturbances in sensation, perception, cognition, communication, and behavior. Globally, CP affects an estimated 17 million individuals, with a birth prevalence of approximately 2 to 2.5 per 1,000 ...더 보기
공식 제목
Telehealth-Supervised Resistance Training to Improve Functional Capacity and Muscle Strength in Children With Cerebral Palsy: Protocol for a Single-Arm Intervention Study
질환명
뇌성마비기타 연구 식별자
- HunanNU-2025-506
NCT 번호
실제 연구 시작일
2026-01-01
최신 업데이트 게시
2025-09-15
예상 연구 완료일
2027-03-01
계획된 등록 인원
50
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
balance
cost
exercise training
gait
group exercise
rehabilitation
strength training
cost
exercise training
gait
group exercise
rehabilitation
strength training
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Telehealth-Supervised Resistance Training The intervention consists of a 12-week telehealth-supervised resistance training program designed for children with mild CP. Training sessions will be conducted live via a secure smartphone-based streaming platform three times per week, with each session lasting approximately 40 minutes. Each session includes a 5-minute warm-up, 30 minutes of structured exercises, and a 5-minute cool-down period. Sessions are schedul...더 보기 | Telehealth-Supervised Resistance Training The exercise protocol will incorporate a variety of exercise modalities adapted for home use in limited space environments. Elastic resistance bands will be used for lower-limb strength exercises such as leg presses, hip abduction, and ankle dorsiflexion, while sandbag-style leg weights will be employed for activities including knee extensions, seated marches, and standing squats. To target balance, low-cost tools su...더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
1-minute walk test | Participants will be instructed to walk as far as possible without running within one minute, and the total distance covered will be recorded. | Baseline (week 0) and post-intervention (week 12) |
10-meter walk test | Participants will be asked to walk as fast as possible for 10 meters. The test will be performed under two conditions - self-selected and fast walking speeds - with the average of three trials recorded per condition. | Baseline (week 0) and post-intervention (week 12) |
Lower-limb muscle strength | Lower-limb muscle strength will be assessed using the 30-second sit-to-stand test (30s STS), a simple, reliable functional test in which children are instructed to complete as many full STS repetitions as possible from a standard chair within 30 seconds (Romin et al., 2024). | Baseline (week 0) and post-intervention (week 12) |
Balance | Balance will be measured using the Pediatric Balance Scale, a 14-item assessment adapted from the Berg Balance Scale that evaluates functional postural control and is validated for ambulatory children with CP (Her et al., 2012). Tasks include standing on one foot, turning in place, and reaching forward | Baseline (week 0) and post-intervention (week 12) |
Pediatric Quality of Life Inventory | To assess life satisfaction and psychosocial well-being, children and their caregivers will complete the Pediatric Quality of Life Inventory™ (PedsQL) - Cerebral Palsy Module (Varni et al., 2006). This validated instrument measures multiple domains, including physical functioning, emotional well-being, and social participation. Both self-report and parent-proxy formats will be utilized for children aged 5-18 years. | Baseline (week 0) and post-intervention (week 12) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
cost-acceptability survey | Caregivers will complete a cost-acceptability survey designed to assess the perceived affordability and feasibility of the telehealth-delivered training model. The survey will include statements such as "The program is affordable for my family," "10 CNY per session is a fair price for the quality of the program," and "I would continue the training even if not reimbursed," rated on a 5-point Likert scale from strongly agree to strongly disagree. Caregivers will also answer an open-ended question: "What is the maximum price you would be willing to pay per session?" These items aim to evaluate the scalability and economic sustainability of this intervention from the perspective of end users. | Post-intervention (week 12) |
참여 도우미
적격성 기준
연령대
어린이
최소 연령
6 Years
참여 가능한 성별
전체
- No history of heart disease or family history of heart disease;
- Children classified as GMFCS levels I, II, or III;
- Dependent on assistive mobility devices, such as wheelchairs or posture support walkers, for activities of daily living;
- Medically stable and able to sit upright for at least 30 minutes;
- Able to understand simple verbal or visual instructions.
- Aged under 6 years or over 15 years;
- Received botulinum toxin A injections for lower limb muscles within six months prior to baseline assessment;
- Implanted with an intrathecal baclofen pump, or has a history of lower limb-related orthopedic or neurosurgical interventions (such as tendon lengthening, osteotomy, or selective dorsal rhizotomy);
- Has uncontrolled epilepsy, severe cognitive impairment, or other comorbidities.
Hunan Normal UniversityShanghai University of Sport연구 책임자
Yang Zhang, 책임연구자, Principle scientist, Hunan Normal University
연구 대표 연락처
연락처: Yang Zhang, PhD, 7272559368, [email protected]
연락처: Dinghua Liu, MS, 8618807486231, [email protected]
시험기관의 위치 정보가 없습니다.