CompletedNot Applicable

Robot-assisted Training

China13 participantsStarted 2025-02-25

Plain-language 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.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in cross sectional area of quadriceps

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in longitudinal cross-sectional width of quadriceps

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in peak torque

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in average torque

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in work of knee

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in Surface Electromyography (sEMG)

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in Nerve conduction

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Trial details

NCT IDNCT06648486

SponsorPeking University Third Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-30

View on ClinicalTrials.gov More Spinal Muscular Atrophy (SMA) trials

Plain-language summary

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in cross sectional area of quadriceps

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in longitudinal cross-sectional width of quadriceps

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in peak torque

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in average torque

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in work of knee

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in Surface Electromyography (sEMG)

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months

Change in Nerve conduction

Timeframe: Baseline, after 1.5 months, after 3 months and after 4 months