Effects of Different Stiffness Settings During Robotic Isokinetic Training in Children With SMA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, within-subject trial compares two stiffness settings (compliant and rigid) of a portable isokinetic knee training robot in children with spinal muscular atrophy. Each participant has one leg trained with the compliant setting and the other with the rigid setting, over up to 8 weeks with the same training volume. Primary outcome is the difference between settings in change from baseline for peak knee-extension torque, with secondary outcomes including range of motion, quadriceps size by MRI, femoral nerve conduction, and sit-to-stand performance. The study also monitors knee pain, skin temperature, fatigue, and other adverse events; enrollment targets at least 13 participants aged 6–12 years. Randomization uses sealed envelopes and the trial is open-label. Eligibility requires SMA diagnosis, age 6–12, ability to sit independently, and stable disease-modifying therapy if applicable.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 6 to 12 years.
2. Diagnosis of spinal muscular atrophy.
3. Able to maintain an independent seated position.
4. If receiving disease-modifying treatment, including nusinersen or risdiplam, the participant must have received a stable dose for at least 6 months before enrollment and must not change the treatment regimen during the study.

Exclusion Criteria:

1. Any other major disease or medical condition that, in the investigator's judgment, would interfere with safe participation or interpretation of the study results.
2. The legal guardian declines to provide written informed consent, or the participant is unable to complete the study procedures.
3. Unable to undergo magnetic resonance imaging or electromyography and nerve conduction testing.
4. Blood pressure above the 95th percentile for age, sex, and height, as assessed by a clinician.
5. Lacks the cognitive capacity to understand or comply with the requirements of study participation.

Where it's running

• Peking University Third Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Fuzhen Yuan, Dr.
• Email: tildaren@163.com
• Phone: +8613111050197

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.