Leg Stretching Using an Exoskeleton on Demand for People With Spasticity

Part of paid clinical trials in Syracuse, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT05926596
Status
Recruiting
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Conditions

  • Movement Disorders
  • Spasticity
  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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)

Study Details

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.

Key Dates

Start date
Feb 9, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Robotic Exoskeleton
    All participants will be interfered with a wearable robotic exoskeleton.

Primary Outcome Measure

3D postures [ Time Frame: Through study completion, an average of 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Syracuse VA Medical Center, Syracuse, NYSyracuseNew York13210-2716
Steven W Brose
[email protected]
315-425-4400
Steven W Brose (PRINCIPAL_INVESTIGATOR)

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By research site
Syracuse VA Medical Center, Syracuse, NY· Syracuse, NY

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