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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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: 2024-12
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in cross sectional area of quadriceps	pre-training, after 10th training session and after 20th training session.（Each session is 2-3 days））	Using Magnetic Resonance Imaging (MRI)
Change in longitudinal cross-sectional width of quadriceps	pre-training, after 10th training session and after 20th training session. （Each session is 2-3 days）	Using Magnetic Resonance Imaging (MRI)
Change in peak torque	pre-training, after each training session (20 sessions in total). （Each session is 2-3 days）	Using isokinetic training robot to measure.
Change in average torque	pre-training, after each training session (20 sessions in total). （Each session is 2-3 days）	Using isokinetic training robot to measure.
Change in work of knee	pre-training, after each training session (20 sessions in total). （Each session is 2-3 days）	Work = Torque \* Speed
Change in Surface Electromyography (sEMG)	pre-training, and after each training session. （Each session is 2-3 days）

Secondary Outcome Measures

Name	Time	Method
Change in weight	Pre-training and post-training. （Each session is 2-3 days）
Change in height	Pre-training and post-training. （Each session is 2-3 days）
Change in joint angle	During each training session. （Each session is 2-3 days）

Trial Locations

Locations (1)

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