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Leg Stretching Using an Exoskeleton on Demand for People With Spasticity

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT05926596

Registry updated: 2026-10-02

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Description

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.

Interventions

Wearable Robotic Exoskeleton (Device)
* Participant preparation, placement of wearable sensors and monitoring, and wearable device fitting. * Lower-limb joint rotations and leg stretching protocol (40-60 minutes). The wearable exoskeleton and its control algorithm are evaluated to rotate leg joints and apply stretching similarly to the forces applied by nurses and caregivers when providing manual forces. Joint rotation and limb stretching is conducted while participants sit down (e.g., in a wheelchair, on a chair, on one side of a bed, or on a clinical mat) or lay down on a bed/mat. The protocol involves ankle plantarflexion and dorsiflexion, knee extension, hip flexion with the knee flexed, and toe flexion and extension (bilaterally) assisted by the exoskeleton, and each movement is repeated at a low-to-moderate rate of 10-30 cycles/minute. * Treadmilll and Overground Walking (60-90 minutes including rest periods) * Cool down (5-10 minutes)

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 or cardiovascular performance or have any ailments causing high fever, high blood pressure, or high heart rate

Conditions

Spasticity Movement Disorders Spinal Cord Injury

Locations

Syracuse VA Medical Center, Syracuse, NY — Syracuse, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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