试验雷达 AI | ||
|---|---|---|
临床试验 NCT07061275 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。 | ||
一个试验符合筛选条件
卡片视图
Telehealth-Supervised Resistance Training for Children With Cerebral Palsy 50 远程医疗 儿科
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07061275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2026年1月1日开始，预计招募50名患者。该研究由Hunan Normal University主导，计划于2027年3月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月15日。
简要概括
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...
详细描述
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 ...显示更多
官方标题
Telehealth-Supervised Resistance Training to Improve Functional Capacity and Muscle Strength in Children With Cerebral Palsy: Protocol for a Single-Arm Intervention Study
疾病
脑瘫其他研究标识符
- HunanNU-2025-506
NCT编号
实际开始日期
2026-01-01
最近更新发布
2025-09-15
预计完成日期
2027-03-01
计划入组人数
50
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
balance
cost
exercise training
gait
group exercise
rehabilitation
strength training
cost
exercise training
gait
group exercise
rehabilitation
strength training
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
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Telehealth-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...显示更多 | 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...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 |
|---|---|---|
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) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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) |
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
- 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 Sport研究责任方
Yang Zhang, 主要研究者, Principle scientist, Hunan Normal University
研究中心联系人
联系人: Yang Zhang, PhD, 7272559368, [email protected]
联系人: Dinghua Liu, MS, 8618807486231, [email protected]
没有位置数据。