Walking and tSCS in Non-ambulatory Stroke Survivors

November 7, 2025 updated by: Wen Liu, Ph.D., University of Kansas Medical Center

Robot-assisted Gait Training and Transcutaneous Spinal Cord Stimulation in Chronic Non-ambulatory Stroke Survivors: Pilot RCT Trial

Rehabilitation interventions commonly used for stroke survivors include task-specific training, balance and strength exercises, and the use of assistive devices to enhance mobility and independence. Advanced technologies, such as body-weight-supported treadmill systems and robotic devices, may be employed when appropriate. Current rehabilitation therapies for stroke survivors are moderately effective with a limited effect size, especially in stroke survivors with severe impairment. Novel therapies, such as transcutaneous spinal cord stimulation (tSCS), may further improve outcomes in the target population. This pilot study will allow us to examine the feasibility and gather pilot data on a combined intervention of assistive gait training and tSCS in non-ambulatory stroke survivors.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Neuromuscular Research Laboratory
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-80 years at time of consent
  2. All genders included.
  3. Chronic ischemic or hemorrhagic stroke >=6 months, with limited within-home comfortable walking speed <= 0.49 m/s and unable to walk independently in community (FAC <= 3)
  4. Able to communicate with investigators, follow 2-step command, and correctly answer consent comprehension questions in English.
  5. Currently not participating in treadmill walking exercises or exercises involving weight-bearing activities.
  6. Have physicians' approval for exercise and be in a stable medical condition

Exclusion Criteria:

  1. Hospitalization for cardiac or pulmonary disease within the past 3 months
  2. Have musculoskeletal disorders that prevent the participant from participating in the exercise
  3. Blood pressure higher than 200/110 mm Hg
  4. Significant ataxia or unilateral spatial neglect (score of 2 on NIH stroke scale item 7 or 11)
  5. Reported pain that limits or interferes with activities of daily living and physical activity/exercise
  6. Diagnosis of other neurological diseases (multiple sclerosis, Alzheimer's disease, Parkinson's disease)
  7. Diagnosis of severe depression (HADS score 15-21)
  8. Unable to speak or understand English, and travel to the research laboratory.
  9. Contraindications to tSCS and TMS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot assisted gait training combined with Transcutaneous spinal cord stimulation
Device: Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial
Participants in the experimental group will receive 30 minutes of robot assisted gait training (RAGT) transcutaneous spinal cord stimulation 3 times per week, 8 weeks, totaling 24 sessions. The gait training will utilize a treadmill equipped with a partial-body-weight support system and a lab-developed RAGT device. The RAGT protocol will be the same as in the control group
Active Comparator: Robot assisted gait training alone
Device: Robot assisted gait training alone
Participants in the control group will receive 30 minutes of assisted gait training (RAGT), 3 times per week, for 8 weeks, totaling 24 sessions. The gait training will utilize a treadmill equipped with a partial-body-weight support system and a lab-developed RAGT device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Output (Measured by Impedance Cardiography - BIOPAC MP160 System)
Time Frame: Before and after 24 training sessions (8 weeks)
Cardiac output (L/min) will be measured using an impedance cardiography system (MP160, BIOPAC Systems Inc., Goleta, California). Measurements will be done during a 6-minute walk test. Data collection for each participant will occur at approximately the same time of day (between 9:00 AM and 11:00 AM) before the first intervention session and after completion of the 24th intervention session.
Before and after 24 training sessions (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Wen Liu, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 4, 2025

First Submitted That Met QC Criteria

November 7, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 7, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00162114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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