An interventional study of Portable Isokinetic Knee Training Robot With an Individually Optimized Compliant Setting and Portable Isokinetic Knee Training Robot With a Rigid Setting in Spinal Muscular Atrophy (SMA), sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
Among 23 studies in Muscular Atrophy, Spinal with a site in China — 8 open to participants now, 13 under way, 4 of them phase 3. Muscular Atrophy, Spinal · China.
Among the 23 studies in Muscular Atrophy, Spinal with a site in China, this one is the 14th largest by planned enrollment of the 16 interventional ones that give a count, is one of 3 that started in 2026, is one of 4 with no phase, reaches primary completion later than 3 of the 12 other live ones, and was the 23rd registered.
282 studies on the registry are indexed under Muscular Atrophy, Spinal; 73 are open to participants now.
Browse Muscular Atrophy, Spinal studies →8 of the 23 studies in Muscular Atrophy, Spinal with a site in China are open now. Recruiting first, the newest first:
Biogen · Sites in China, United States
Ages 15–60
Biogen · Sites in China, United States, Australia and 4 more countries
Ages 0 days–42 days
GeneCradle Inc · Sites in China
Ages 2–12
GeneCradle Inc · Sites in China
Ages 0 mo–6 mo
Wan-Jin Chen · Sites in China
Ages 1 wk–70 yrs · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 58 Muscular Atrophy, Spinal studies recruiting now, 28 (48%) set no upper age limit and 27 (47%) stop at 75 or younger; 46 take children under 18; 11 take healthy volunteers.
This study: 6 Years to 12 Years · all sexes · no healthy volunteers.
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23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 4 · Phase 3 7
First in 2016; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 13 is below the median of 29 across 156 interventional studies indexed under Muscular Atrophy, Spinal.
Median enrollment 35 across the 16 interventional studies, 200 across the 7 observational. Of the 8 that completed or were terminated, 4 (50%) have results posted.
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17 of 23 have an industry lead sponsor. The 10 most frequent:
Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
Peking University Third Hospital has 2 studies filed under Muscular Atrophy, Spinal — fewer than ten, so there is no comparison to draw.
5 of the studies in Muscular Atrophy, Spinal with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06971094Phase 3GeneCradle IncSafety and Efficacy Evaluation of GC101 Gene Therapy Via Intrathecal (IT) Injectionin the Treatment of Patients With Type 2 Spinal Muscular Atrophy (SMA) - Phase III | 2026-12-31 |
| NCT05824169GeneCradle IncEvaluation of Safety and Efficacy of Gene Therapy Drug in the Treatment of Spinal Muscular Atrophy (SMA) Type 1 Patients | 2026-12 |
| NCT07822711Peking University Third HospitalEffects of Different Stiffness Settings During Robotic Isokinetic Training in Children With SMA | 2027-01-15 |
| NCT05042921BiogenPediatric Spinal Muscular Atrophy (SMA) China Registry | 2027-09-02 |
| NCT06288230Lantu BiopharmaAn Open Label Study of Gene Therapy Product (Vesemnogene Lantuparvovec) in Spinal Muscular Atrophy | 2027-10-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 23 studies in Muscular Atrophy, Spinal with a site in China, from their registry updates:
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This randomized, within-participant, contralateral-limb-controlled clinical trial will compare individually optimized compliant and rigid stiffness settings of a portable isokinetic knee training robot in children with spinal muscular atrophy. At least 13 children aged 6 to 12 years will be enrolled. For each participant, one leg will be randomly assigned to the compliant setting and the contralateral leg to the rigid setting using sequentially numbered, opaque, sealed envelopes. Both legs will receive the same training volume, number of repetitions, and angular velocity for up to 8 weeks. The primary outcome is the between-setting difference in the change from baseline in peak isokinetic knee-extension torque. Secondary outcomes include knee-extension range of motion, quadriceps cross-sectional area on magnetic resonance imaging, femoral nerve conduction measures, and sit-to-stand performance. Knee pain, suprapatellar skin temperature, fatigue, and other adverse events will be monitored throughout the study.
Spinal muscular atrophy is characterized by progressive muscle weakness and impaired motor function. Quadriceps weakness limits knee extension, transfers, standing, and other activities of daily living. A portable isokinetic knee training robot has previously been shown to provide safe, quantifiable resistance training in children with spinal muscular atrophy. The present study will investigate whether the stiffness of the human-robot interaction affects rehabilitation outcomes.
Participants will be randomized to one of two laterality schemes: (A) compliant setting for the left leg and rigid setting for the right leg, or (B) rigid setting for the left leg and compliant setting for the right leg. An independent statistician will generate the random sequence, which will be concealed in sequentially numbered, opaque, sealed envelopes. The study is open label.
Before training, participants will undergo bilateral quadriceps magnetic resonance imaging, femoral nerve conduction testing, biomechanical assessment, and determination of the individually optimized compliant stiffness. Under the compliant setting, stiffness will be selected within the predefined safe range as the level that produces the highest mean peak knee-extension torque across five repetitions while the movement remains painless, without obvious fatigue, and with a stable trajectory.
Training will continue for up to 8 weeks, with no more than five sessions per week. During each session, the robot will be worn on one leg at a time while the contralateral leg is stabilized. Participants will perform seated knee extension and flexion at a target angular velocity of 45 degrees per second, adjusted when clinically necessary. The initial knee angle will be 90 degrees, and movement will occur within each participant's maximum voluntary pain-free range of motion. A standard set will consist of 10 continuous extension-flexion repetitions, with at least six sets per leg and approximately 1 minute of rest between sets. The number of repetitions, sets, and rest duration may be adjusted according to participant tolerance, but the training dose will be matched between the two legs. Total session duration will be approximately 35 minutes.
The robot software will record training data, including knee-extension peak torque and joint angle. After the intervention, bilateral quadriceps magnetic resonance imaging, femoral nerve conduction testing, and biomechanical assessments will be repeated. Participants will be evaluated in person before and after the intervention and contacted weekly by telephone during training to assess knee pain, discomfort, fatigue, and subjective changes in strength.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to scheme A will receive isokinetic knee training with the individually optimized compliant stiffness setting on the left leg and the rigid stiffness setting on the right leg. Training dose, angular velocity, number of repetitions, number of sets, and rest periods will be matched between the two legs.
Device: Portable Isokinetic Knee Training Robot With an Individually Optimized Compliant Setting · Device: Portable Isokinetic Knee Training Robot With a Rigid Setting
Participants assigned to scheme B will receive isokinetic knee training with the rigid stiffness setting on the left leg and the individually optimized compliant stiffness setting on the right leg. Training dose, angular velocity, number of repetitions, number of sets, and rest periods will be matched between the two legs.
Device: Portable Isokinetic Knee Training Robot With an Individually Optimized Compliant Setting · Device: Portable Isokinetic Knee Training Robot With a Rigid Setting
The compliant setting will be individualized within the device's predefined safe stiffness range. At each candidate stiffness, the participant will perform five knee-extension repetitions. The stiffness producing the highest mean peak knee-extension torque while the movement remains painless, without obvious fatigue, and with a stable trajectory will be selected. The assigned limb will then train at this setting for up to 8 weeks, no more than five sessions per week. Each session will use a target angular velocity of 45 degrees per second, an individualized maximum voluntary pain-free range of motion, at least six sets of 10 extension-flexion repetitions per leg, and approximately 1 minute of rest between sets. Training volume will be matched to the contralateral limb.
The assigned limb will train with the device's predefined rigid stiffness setting for up to 8 weeks, no more than five sessions per week. Each session will use a target angular velocity of 45 degrees per second, an individualized maximum voluntary pain-free range of motion, at least six sets of 10 extension-flexion repetitions per leg, and approximately 1 minute of rest between sets. Training volume will be matched to the contralateral limb.
Between-setting difference in the change from baseline in peak knee-extension torque
Peak isokinetic knee-extension torque will be measured separately for each limb using the portable isokinetic knee training robot and reported in newton-meters. For each participant, the change from baseline will be calculated for the compliant-setting limb and the rigid-setting limb. The primary outcome is the within-participant difference between these two changes: (post-intervention minus baseline change for the compliant setting) minus (post-intervention minus baseline change for the rigid setting).
Time frame: Baseline and immediately after the intervention period, up to 8 weeks
Between-setting difference in the change from baseline in active knee-extension range of motion
Active knee-extension range of motion will be measured separately for each limb by the robot and reported in degrees. The outcome is the within-participant difference between the compliant-setting and rigid-setting limbs in change from baseline.
Time frame: Baseline and immediately after the intervention period, up to 8 weeks
Between-setting difference in the change from baseline in quadriceps cross-sectional area
Quadriceps cross-sectional area will be quantified separately for each thigh using magnetic resonance imaging and reported in square centimeters. The outcome is the within-participant difference between the compliant-setting and rigid-setting limbs in change from baseline.
Time frame: Baseline and immediately after the intervention period, up to 8 weeks
Between-setting difference in the change from baseline in femoral nerve compound muscle action potential amplitude
Femoral nerve conduction testing will be performed separately for each limb. Compound muscle action potential amplitude will be reported in millivolts. The outcome is the within-participant difference between the compliant-setting and rigid-setting limbs in change from baseline.
Time frame: Baseline and immediately after the intervention period, up to 8 weeks
Change from baseline in the minimum initial knee angle for successful sit-to-stand performance
The minimum initial knee flexion angle from which the participant can successfully complete an unassisted sit-to-stand task will be measured in degrees. The post-intervention value will be compared with baseline at the participant level.
Time frame: Baseline and immediately after the intervention period, up to 8 weeks
Plan to share: No — Individual participant data will not be shared because the study involves children with a rare disease and a small sample size, which may increase the risk of participant re-identification.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2027, 2 months later.
Of 48 non-industry interventional studies with no phase under Muscular Atrophy, Spinal, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 2 months is below that.
Counting every sponsor, half of 57 studies reached it within 27 months; a quarter within 17 and three quarters within 51.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 23, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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