Spinal Stimulation for Upper Extremity Recovery in the Home

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Craig Hospital
Study ID
NCT06743607
Status
Recruiting
Apply to this trial

Conditions

  • Cervical Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Immediate Intervention — BEHAVIORAL
    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.
  • Waitlist control — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
May 28, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Immediate Intervention
    For the immediate intervention group, each participant will complete the following: * Initial baseline evaluation * 24 training sessions (3x/week for eight weeks) of UE Functional Task Practice (FTP)+TSS (two training sessions/week will be completed in the home with caregiver/companion support; the third weekly session will be conducted via videoconference with a research therapist) * Post-treatment evaluation (after eight weeks of training) and follow-up evaluation (four weeks after post-treatment evaluation). * Post-treatment and follow-up assessments will be conducted over two days: assessments completed without TSS on day one and with TSS on day two.
  • Active Comparator: Waitlist Control
    The waitlist control group will participate in a protocol similar to the immediate intervention group, except: * 12-week waiting period before starting the active intervention. * Assessments will be completed at 0, 8, and 12 weeks before starting the active intervention to control for spontaneous recovery. * Post-treatment evaluation (after eight weeks of training) * Follow-up assessment (four weeks after the post-treatment evaluation).

Primary Outcome Measure

Capabilities of Upper Extremity Questionnaire (CUE-Q) [ Time Frame: Weeks 0, 8, 12, 21, and 25 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Craig HospitalEnglewoodColorado80113
Candy Tefertiller, PT, DPT, PhD, NCS
[email protected]
303-789-8000
Bria Mellick, MS
[email protected]
303-789-8757
Candy Tefertiller, PT, DPT, PhD, NCS (PRINCIPAL_INVESTIGATOR)

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Craig Hospital· Englewood, CO

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