Leg Stretching Using an Exoskeleton on Demand for People With Spasticity

NCT05926596 | Recruiting

• 2 other identifiers: A4652-P1I21RX004652-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity; Movement Disorders; Spinal Cord Injury

Keywords

exoskeleton; spasticity

Outcome Measures

Primary Outcomes (3)

• 3D postures

  3D postures will be assessed using the device, combining measurements of multiple joints in space

  Through study completion, an average of 24 weeks

• Joint angles

  Hip and knee joint angles measured in degrees will be assessed using the device

  Through study completion, an average of 24 weeks

• Joint angular velocities

  Hip and knee joint velocities measured in radians per second or degrees per second will be assessed using the device

  Through study completion, an average of 24 weeks

Study Arms (1)

Robotic Exoskeleton

EXPERIMENTAL

All participants will be interfered with a wearable robotic exoskeleton.

Device: Wearable Robotic Exoskeleton

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)

Robotic Exoskeleton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Syracuse University: collaborator

Study Sites (1)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

RECRUITING

MeSH Terms

Conditions

Muscle Spasticity; Movement Disorders; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Steven W Brose

  Syracuse VA Medical Center, Syracuse, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven W Brose

CONTACT

(315) 425-4400; steven.brose@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: All participants will be interfered with with a wearable robotic exoskeleton.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: February 9, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)