Walking and tSCS in Non-ambulatory Stroke Survivors

NCT07226518 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: STUDY00162114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Stroke Survivors; Chronic Stroke Patients; Stroke

Keywords

stroke gait rehabilitation; Transcutaneous spinal cord stimulation; Non invasive spinal cord stimulation; Robot assisted gait training

Outcome Measures

Primary Outcomes (1)

• Cardiac Output (Measured by Impedance Cardiography - BIOPAC MP160 System)

  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)

Study Arms (2)

Robot assisted gait training combined with Transcutaneous spinal cord stimulation

EXPERIMENTAL

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

Robot assisted gait training alone

ACTIVE COMPARATOR

Device: Robot assisted gait training alone

Interventions

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 combined with Transcutaneous spinal cord stimulation

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

Robot assisted gait training alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

Neuromuscular Research Laboratory

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Wen Liu, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustapha Mangdow, PT. MS

CONTACT

913-2421754; mmangdow@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 10, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)