Walking and tSCS in Non-ambulatory Stroke Survivors

NCT ID: NCT07226518

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Detailed Description

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Conditions

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Chronic Stroke Survivors Chronic Stroke Patients Stroke

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

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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

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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

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Wen Liu, Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wen Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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Neuromuscular Research Laboratory

Kansas City, Kansas, United States

Site Status

Countries

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United States

Central Contacts

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Mustapha Mangdow, PT. MS

Role: CONTACT

Phone: 913-2421754

Email: [email protected]

Facility Contacts

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Mustapha Mangdow, PT, MS

Role: primary

Wen Liu, PhD

Role: backup

Other Identifiers

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STUDY00162114

Identifier Type: -

Identifier Source: org_study_id