Evaluation of a Portable Isokinetic Knee Training Device for Quadriceps Rehabilitation in Children With SMA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Muscular Atrophy (SMA)
- Sponsor
- Peking University Third Hospital
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Change in cross sectional area of quadriceps
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Investigators
Yuan Fuzhen
Principle Investigator
Peking University Third Hospital
Eligibility Criteria
Inclusion Criteria
- •Age range: 6-12 years old.
- •Diagnosed with Type II Spinal Muscular Atrophy (SMA).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in cross sectional area of quadriceps
Time Frame: 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
Time Frame: Baseline, after 1.5 months, after 3 months and after 4 months
Using Magnetic Resonance Imaging (MRI)
Change in peak torque
Time Frame: Baseline, after 1.5 months, after 3 months and after 4 months
Using isokinetic training robot to measure.
Change in average torque
Time Frame: Baseline, after 1.5 months, after 3 months and after 4 months
Using isokinetic training robot to measure.
Change in work of knee
Time Frame: Baseline, after 1.5 months, after 3 months and after 4 months
Work = Torque \* Speed
Change in Surface Electromyography (sEMG)
Time Frame: Baseline, after 1.5 months, after 3 months and after 4 months
Change in Nerve conduction
Time Frame: Baseline, after 1.5 months, after 3 months and after 4 months
Nerve Conduction Velocity Testing System
Secondary Outcomes
- 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)