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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Robot-assisted gait training and transcutaneous spinal cord stimulation in chronic non-ambulatory stroke survivors: pilot RCT trial
DeviceParticipants 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
DeviceParticipants 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
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Robot assisted gait training combined with Transcutaneous spinal cord stimulationExperimental treatment 1 intervention
Group B: Robot assisted gait training aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Before and after 24 training sessions (8 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: