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RecruitingNCT05926596

Leg Stretching Using an Exoskeleton on Demand for People With Spasticity

◆ AI Clinical Summary

This study tests a wearable robotic exoskeleton (a motorized device worn on the legs) to help improve leg function and walking in people with spasticity, a condition that causes muscle stiffness and difficulty moving. Researchers will have you wear the device during stretching exercises and other activities to see if it helps reduce stiffness and improve your ability to walk and move.

Key Objective:The trial is testing whether a portable exoskeleton can improve leg flexibility, reduce muscle stiffness, and enhance walking ability in people with spasticity.

Who to Consider:People with spasticity or movement disorders who are interested in trying new technology-based treatments to improve their leg function and mobility should consider enrolling.

Trial Parameters

ConditionSpasticity
SponsorVA Office of Research and Development
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment10
SexALL
Min Age18 Years
Max AgeN/A
Start Date2026-02-09
Completion2026-09-30
Interventions
Wearable Robotic Exoskeleton

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Brief Summary

The purpose of this research study is to develop a protocol using a fully wearable, portable lower-limb exoskeleton for improving leg and walking function in people with movement disorders. The study investigates the effects of wearing the device during a set of experiments including leg stretching, treadmill walking and overground walking in muscle activity, joint motion, and gait performance. The goal is to develop an effective lower-limb strategy to restore lost leg function (e.g., range of motion) and gait ability, and improve quality of life in people with movement deficits following a neurological disorder.

Eligibility Criteria

Inclusion Criteria: * Veteran individuals with spasticity due to spinal cord injury (SCI) at least 6 months post SCI * Capable of providing informed consent and reporting age, gender, and neurological condition * Neurologically stable (\>6 months post-SCI) and can wear the device and the sensors, provide written informed consent, and follow instruction Exclusion Criteria: * Participants should not experience another neurological disorder except their primary diagnosed neurological condition (spinal cord injury) * Participants should not be pregnant * Participants should weigh less than 300 lbs * Participants should not have experienced signs of hip/knee pain during the past 2-3 weeks that limits mobility (i.e., reaching, walking, lifting, etc.) * Participants should be recovered from any previous surgical interventions, joint injuries, muscle strain, or extreme muscle soreness following surgery * Participants should not take medications known to affect bone metabolism, muscle strength

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