Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke

NCT05167786 | Recruiting FDA Device

• 1 other identifier: STU00215009
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

This study has two interventional components, the first is a cross-over design and the second is a randomized control trial. Both will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Gait Symmetry

  Participants will ambulate along Gait Rite electronic walkway 3 times per gait speed to evaluate gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet and connected to a computer. The system can be laid over any flat surface and automates measuring temporal and spatial gait parameters. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality.

  Aim 1: Baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.

Secondary Outcomes (2)

• Change in 6 Minute Walk Test

  Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.

• Change in 10 Meter Walk Test

  Aim 1: Baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.

Study Arms (4)

Aim 1: Gait Training + Stimulation

EXPERIMENTAL

Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

Device: Noninvasive spinal stimulation with gait training; Other: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation

Aim 1: Gait Training + Sham Stimulation

ACTIVE COMPARATOR

Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

Device: Conventional gait training

Aim 2: Gait Training + Stimulation

EXPERIMENTAL

Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

Device: Noninvasive spinal stimulation with gait training; Other: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation

Aim 2: Gait Training + Sham Stimulation

ACTIVE COMPARATOR

Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

Device: Conventional gait training

Interventions

Conventional gait training DEVICE

Subjects will receive lower limb locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.

Aim 1: Gait Training + Sham Stimulation; Aim 2: Gait Training + Sham Stimulation

Exploratory Phase - Optimization of Gait Training and Spinal Stimulation OTHER

Subjects may receive various lower limb locomotion training with or without transcutaneous spinal cord stimulation. Training approaches may include but are not limited to single or split belt treadmill and over ground walking. Transcutaneous Spinal Cord Neurostimulator may deliver a variety of transcutaneous electrical spinal cord stimulation to subjects.

Aim 1: Gait Training + Stimulation; Aim 2: Gait Training + Stimulation

Noninvasive spinal stimulation with gait training DEVICE

Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform lower limb locomotor activities.

Aim 1: Gait Training + Stimulation; Aim 2: Gait Training + Stimulation

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Able and willing to give written consent and comply with study procedures
• At least 6 months' post-stroke
• Hemiplegia secondary to a single stroke
• Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and coordination.
• Not currently receiving regular physical therapy services
• Physician approval to participate

You may not qualify if:

• Ataxia
• Multiple stroke history
• Botox injection in lower extremity within the last 4 months
• Modified Ashworth score of 3 or greater in lower extremity
• Pregnant or nursing
• Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD) or anti-spasticity implantable pumps
• Active pressure sores
• Unhealed bone fractures
• Peripheral neuropathies
• Painful musculoskeletal dysfunction due to active injuries or infections
• Severe contractures in the lower extremities
• Medical illness limiting the ability to walk
• Active urinary tract infection
• Clinically significant depression, psychiatric disorders, or ongoing drug abuse
• Active cancer or cancer in remission less than 5 years

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly McKenzie, DPT

CONTACT

312-238-7111; kmckenzie@sralab.org

Sara Prokup, DPT

CONTACT

3122381355; sprokup@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 22, 2021
• Study Start: March 1, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)