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RECRUITINGINTERVENTIONAL

Robot-assisted Training

Evaluation of a Portable Isokinetic Knee Training Device for Quadriceps Rehabilitation in Children With SMA

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age range: 6-12 years old. 2. Diagnosed with Type II Spinal Muscular Atrophy (SMA). Who Should NOT Join This Trial: 1. Participants with severe comorbidities, implanted medical devices preventing MRI or claustrophobia were excluded from the study. 2. Refusal to provide willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

With the assistance of wearable isokinetic training robot （ 7 children with SMA type II）

A child with SMA will use a wearable isokinetic training robot to train the knee joint for three stages. ( Stage 1: 1.5 months=30 sessions; Stage 2 (follow up): 1.5 months=18 sessions, Stage 3(follow up) = 0 session)

Locations (1)

Peking University Third Hospital
Beijing, Beijing Municipality, China