Walking and tSCS in Non-ambulatory Stroke Survivors

University of Kansas

Status: Not yet enrolling

Conditions: Chronic Stroke Survivors; Stroke; Chronic Stroke Patients

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07226518

STUDY00162114

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Robot assisted gait training combined with Transcutaneous spinal cord stimulation

Experimental group

Treatment:

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 group

Treatment:

Device: Robot assisted gait training alone