Evaluation of a Portable Isokinetic Knee Training Device for Quadriceps Rehabilitation in Children With SMA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in cross sectional area of quadriceps
研究概览
简要总结
The goal of this clinical trial is to evaluate the long-term effects of isokinetic rehabilitation training in patients with spinal muscular atrophy (SMA). The main question it aims to answer is:
• Does isokinetic training at fixed angular velocity improve muscle strength and functional recovery in SMA patients?
Participants will:
- Perform isokinetic training using a portable device with a fixed angular velocity.
- Undergo long-term rehabilitation sessions, with assessments of muscle strength and overall functional improvement over the training period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
7 Children with SMA, 6 Healthy Children as comparison
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
- •Age range: 6-12 years old.
- •Diagnosed with Type II Spinal Muscular Atrophy (SMA).
排除标准
- •Participants with severe comorbidities, implanted medical devices preventing MRI or claustrophobia were excluded from the study.
- •Refusal to provide informed consent or inability to complete the entire study protocol, among other factors;
- •Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥95 mmHg) or congestive heart failure classified as New York Heart Association (NYHA) Class III or IV;
- •Cognitively impaired or unable to comprehend the requirements of study participation.
研究组 & 干预措施
Biomechanical measures for healthy children
A single set of biomechanical measurements will be taken from healthy children to serve as a reference baseline.
Robot-assisted Rehabilitation for children with SMA type II
干预措施: With the assistance of wearable isokinetic training robot （ 7 children with SMA type II） (Device)
Non-robot-assisted Rehabilitation for children with SMA type II
Prior to the intervention, all participants will complete a 1.5-month "Stage 0" observation period with no robot assistance. During this time, we will record each child's sit-to-stand angle to establish baseline (control) measurements.
结局指标
主要结局
Change in cross sectional area of quadriceps
时间窗: Baseline, after 1.5 months, after 3 months and after 4 months
Using Magnetic Resonance Imaging (MRI)
Change in longitudinal cross-sectional width of quadriceps
时间窗: Baseline, after 1.5 months, after 3 months and after 4 months
Using Magnetic Resonance Imaging (MRI)
Change in peak torque
时间窗: Baseline, after 1.5 months, after 3 months and after 4 months
Using isokinetic training robot to measure.
Change in average torque
时间窗: Baseline, after 1.5 months, after 3 months and after 4 months
Using isokinetic training robot to measure.
Change in work of knee
时间窗: Baseline, after 1.5 months, after 3 months and after 4 months
Work = Torque \* Speed
Change in Surface Electromyography (sEMG)
时间窗: Baseline, after 1.5 months, after 3 months and after 4 months
Change in Nerve conduction
时间窗: Baseline, after 1.5 months, after 3 months and after 4 months
Nerve Conduction Velocity Testing System
次要结局
- Change in weight(Baseline, after 1.5 months, after 3 months and after 4 months)
- Change in height(Baseline, after 1.5 months, after 3 months and after 4 months)
- Change in joint angle(Baseline, after 1.5 months, after 3 months and after 4 months)
研究者
Yuan Fuzhen
Principle Investigator
Peking University Third Hospital