Walking and tSCS in Non-ambulatory Stroke Survivors

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Kansas Medical Center

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

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

Treatment groups

20 Participants
are divided into 2 treatment groups