What this study is
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.
What's being tested
- Wearable Robotic Exoskeleton
Intervention · 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)
Study details
- Official title
- Leg Stretching Using a Controllable Wearable Exoskeleton on Demand for People With Spasticity
- Sponsor
- VA Office of Research and Development
- Conditions
- Spasticity · Movement Disorders · Spinal Cord Injury
- Enrolling
- 10 people
- Starts
- 2026-02-09
- Est. completion
- 2027-04-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSyracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States
- Steven W Brose · Contact(315) 425-4400steven.brose@va.gov
- Steven W Brose · Principal investigator
Recruiting
Study team
Sponsor
VA Office of Research and Development
Study ID A4652-P
Principal investigator
Steven W Brose
Syracuse VA Medical Center, Syracuse, NY
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.