Home-Based Digital Rehabilitation Program Optimized With Transcutaneous Spinal Cord Stimulation for Upper Limb Functional Enhancement in Tetraplegia (HOPE): A Safety, Efficacy, and Feasibility Study

Sponsor
Singapore General Hospital
Study ID
NCT07438353
Status
Not Yet Recruiting

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Conditions

  • Quadriplegia/Tetraplegia
  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Home-based digital rehabilitation programme with tSCS — DEVICE
    Home-based digital rehabilitation programme with tSCS introduced at staggered time points following varying duration of baseline usual care

Study Details

Individuals with chronic cervical spinal cord injury (SCI) and tetraplegia commonly experience persistent impairment in upper limb function, leading to reduced independence and quality of life. Transcutaneous spinal cord stimulation (tSCS) is a non-invasive neuromodulation technique that has demonstrated potential to improve upper limb strength and function when combined with rehabilitation. However, access to tSCS is limited in Singapore due to cost, regulatory barriers, and the need for frequent outpatient therapy. This study evaluates the safety, efficacy, and feasibility of a home-based digital rehabilitation program incorporating tSCS delivered using a commercially available neuromuscular electrical stimulation (NMES) device. Using a prospective, open-label single-case experimental design with multiple baselines across participants, individuals with chronic, non-progressive cervical SCI will receive daily home-based tSCS combined with an mobile application-guided upper limb exercise program. Upper limb function, quality of life, feasibility, and safety outcomes will be assessed longitudinally over a 22-week study period.

Key Dates

First listed
Feb 27, 2026
Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Other: Group 1 (intervention at end of Week 4)
    Intervention begins at the end of week 4 and continues for 18 weeks till week 22
  • Other: Group 2 (intervention at end of Week 10)
    Intervention begins at the end of week 10 and continues for 12 weeks till week 22
  • Other: Group 3(intervention at end of Week 16)
    Intervention begins at the end of week 16 and continues for 6 weeks till week 22

Primary Outcome Measure

Upper limb function [ Time Frame: Every 2 weeks for total 22 weeks to collect up to 12 data points ]

Central Contacts

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