Walking and tSCS in Non-ambulatory Stroke Survivors

NCT ID: NCT07226518

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Robot assisted gait training combined with Transcutaneous spinal cord stimulation

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Robot assisted gait training alone

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Wen Liu, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wen Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Neuromuscular Research Laboratory

Kansas City, Kansas, United States

Countries

United States

Central Contacts

Mustapha Mangdow, PT. MS

Role: CONTACT

mmangdow@kumc.edu

913-2421754

Facility Contacts

Mustapha Mangdow, PT, MS

Role: primary

mmangdow@kumc.edu

9132421754

Wen Liu, PhD

Role: backup

wliu@kumc.edu

Other Identifiers

STUDY00162114

Identifier Type: -

Identifier Source: org_study_id