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NCT Number: NCT07226518

Walking and tSCS in Non-ambulatory Stroke Survivors

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.

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Key information

Conditions

Chronic Stroke Survivors Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Stroke Patients Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years at time of consent
  • All genders included.
  • 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)
  • Able to communicate with investigators, follow 2-step command, and correctly answer consent comprehension questions in English.
  • Currently not participating in treadmill walking exercises or exercises involving weight-bearing activities.
  • Have physicians' approval for exercise and be in a stable medical condition

Exclusion criteria

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

Treatment and study plan

Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial

Device

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

Robot assisted gait training alone

Device

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mustapha Mangdow, PT. MS

CONTACT

[email protected]

913-2421754

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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