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Effects of Different Stiffness Settings During Robotic Isokinetic Training in Children With SMA
Sponsor: Peking University Third Hospital
Summary
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.
Official title: Effects of Different Stiffness Settings on Isokinetic Quadriceps Training in Children With Spinal Muscular Atrophy: A Randomized Within-Participant, Contralateral-Limb-Controlled Trial
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
13
Start Date
2026-09-21
Completion Date
2027-01-30
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
Portable Isokinetic Knee Training Robot With an Individually Optimized Compliant 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.
Portable Isokinetic Knee Training Robot With a Rigid Setting
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.
Locations (1)
Peking University Third Hospital
Beijing, China