NCT07226518

Walking and tSCS in Non-ambulatory Stroke Survivors

Robot-assisted Gait Training and Transcutaneous Spinal Cord Stimulation in Chronic Non-ambulatory Stroke Survivors: Pilot RCT Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-11-10
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study