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 Start: 2024-10-03
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-18
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-07-20
• Study Completion: 2025-07-20

Recruitment & Eligibility

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

Inclusion Criteria

1. Age range: 5-30 years old.
2. Patients with spinal muscular atrophy (SMA).
3. The subject or guardian is willing and able to sign an informed consent form.

Exclusion Criteria

1. Simultaneously suffering from other major diseases or illnesses.
2. Special populations such as pregnant and lactating women.
3. Refusing to sign the informed consent form or being unable to complete the entire research process.
4. Currently infected with human immunodeficiency virus (HIV), infectious hepatitis B or C, or corresponding medical history.
5. Simultaneously suffering from medical problems, including but not limited to the following:

Uncontrolled hypertension (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 95mmHg), congestive heart failure (New York Heart Association status classification III or IV).

The participant is mentally incapable or unable to understand the requirements for participating in the study.

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, China