Robot-assisted Training

Not Applicable

Recruiting

• Conditions: Spinal Muscular Atrophy (SMA)

• Registration Number: NCT06648486
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-18
• Study Start: 2025-02-25
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-27
• Last Update Posted: 2025-08-29
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Age range: 6-12 years old.
2. Diagnosed with Type II Spinal Muscular Atrophy (SMA).

Exclusion Criteria

1. Participants with severe comorbidities, implanted medical devices preventing MRI or claustrophobia were excluded from the study.
2. Refusal to provide informed consent or inability to complete the entire study protocol, among other factors;
3. 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;
4. Cognitively impaired or unable to comprehend the requirements of study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in cross sectional area of quadriceps	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	Baseline, after 1.5 months, after 3 months and after 4 months	Using Magnetic Resonance Imaging (MRI)
Change in peak torque	Baseline, after 1.5 months, after 3 months and after 4 months	Using isokinetic training robot to measure.
Change in average torque	Baseline, after 1.5 months, after 3 months and after 4 months	Using isokinetic training robot to measure.
Change in work of knee	Baseline, after 1.5 months, after 3 months and after 4 months	Work = Torque \* Speed
Change in Surface Electromyography (sEMG)	Baseline, after 1.5 months, after 3 months and after 4 months
Change in Nerve conduction	Baseline, after 1.5 months, after 3 months and after 4 months	Nerve Conduction Velocity Testing System

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing Municipality, China