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RECRUITING
NCT06743607
NA

Spinal Stimulation for Upper Extremity Recovery in the Home

Sponsor: Craig Hospital

View on ClinicalTrials.gov

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).

Official title: Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SSTIM UE Recover [SURe])

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2025-05-28

Completion Date

2027-08

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

BEHAVIORAL

Immediate 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.

BEHAVIORAL

Waitlist 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.

Locations (1)

Craig Hospital

Englewood, Colorado, United States