Chronic Stroke SurvivorsNCT07226518
Walking and tSCS in Non-ambulatory Stroke Survivors
A study testing Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial and Robot assisted gait training alone in people with Chronic Stroke Survivors and Chronic Stroke Patients, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke Survivors, Chronic Stroke Patients, Stroke
- What is being tested?
- Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial and Robot assisted gait training alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Neuromuscular Research Laboratory
Kansas City, Kansas, 66160
Mustapha Mangdow, PT, MS, 9132421754, mmangdow@kumc.edu
Wen Liu, PhD, wliu@kumc.edu
About this study
Official title: 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.
- Conditions
- Chronic Stroke Survivors, Chronic Stroke Patients, Stroke
- Being tested
- Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial, Robot assisted gait training alone
- Keywords
- stroke gait rehabilitation, Transcutaneous spinal cord stimulation, Non invasive spinal cord stimulation, Robot assisted gait training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trialDevice
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 aloneDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted gait training combined with Transcutaneous spinal cord stimulation | Experimental | Not described Receives: 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 | Not described Receives: Device: Robot assisted gait training alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after 24 training sessions (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stroke SurvivorsStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Liu, Ph.D., University of Kansas Medical Center
- Investigators
- Wen Liu, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226518
- Sponsor's protocol ID
- STUDY00162114
- Status last verified
- Nov 2025
- First submitted
- 4 Nov 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Gait Training and Transcutaneous Spinal Cord Stimulation in Chronic Non-ambulatory Stroke Survivors: Pilot RCT Trial
- ClinicalTrials.gov ID
- NCT07226518
- Acronym / sponsor ID
- STUDY00162114
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trialParticipants 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 | Device | Robot assisted gait training combined with Transcutaneous spinal cord stimulation |
| Robot assisted gait training aloneParticipants 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 | Device | Robot assisted gait training alone |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wen Liu, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial and Robot assisted gait training alone in people with Chronic Stroke Survivors and Chronic Stroke Patients, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustapha Mangdow, PT. MS (913-2421754, mmangdow@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (Measured by Impedance Cardiography - BIOPAC MP160 System) (time frame: Before and after 24 training sessions (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.