Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study has two interventional components, the first is a cross-over design and the second is a randomized control trial. Both will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years or older
• Able and willing to give written consent and comply with study procedures
• At least 6 months' post-stroke
• Hemiplegia secondary to a single stroke
• Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and coordination.
• Not currently receiving regular physical therapy services
• Physician approval to participate
Locations
United States
Illinois
Shirley Ryan AbilityLab
RECRUITING
Chicago
Contact Information
Primary
Kelly McKenzie, DPT
kmckenzie@sralab.org
312-238-7111
Backup
Sara Prokup, DPT
sprokup@sralab.org
3122381355
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 115
Treatments
Experimental: Aim 1: Gait Training + Stimulation
Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
Active_comparator: Aim 1: Gait Training + Sham Stimulation
Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
Experimental: Aim 2: Gait Training + Stimulation
Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
Active_comparator: Aim 2: Gait Training + Sham Stimulation
Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
Related Therapeutic Areas
Sponsors
Leads: Shirley Ryan AbilityLab
Collaborators: University of California, Los Angeles