Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SSTIM UE Recover [SURe])
Craig Hospital
Summary
The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times \[at weeks 0, 8, and 12\] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 or older * History of traumatic SCI * Less than 12 months post SCI * SCI injury level C1-C8 * SCI categorized as AIS B-D * Have passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows * Have caregiver support to attend three in-person sessions and ongoing training at home * Have a caregiver who, in the judgment of the research team, is qualified to assist the participant in the safe use of TSS * Able to complete in-person training sessions and return to Craig Hospital for assessments * Experience no complicating physical or cognitiv…
Interventions
- BehavioralImmediate Intervention
Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences immediately after enrollment.
- BehavioralWaitlist control
Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences 12 weeks after enrollment.
Location
- Craig HospitalEnglewood, Colorado