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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorSingapore General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age 21 -75 years;

Non-progressive cervical SCI/spinal cord dysfunction (traumatic or non-traumatic);

Duration of SCI/spinal cord dysfunction more than or equal to 12 months;

ASIA Impairment scale (AIS B, C, or D) with impaired upper limb function;

Disqualifiers

Significant or unstable medical co-morbidities including uncontrolled cardiopulmonary disease, severe cognitive impairment, severe dysautonomia, as determined by the investigator;

Pregnancy;

History of other neurologic conditions affecting upper limb function, such as stroke, multiple sclerosis, or traumatic brain injury;

Known history of peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc);

Trial design

Treatments tested in this trial

  • Home-based digital rehabilitation programme with tSCS

Treatment groups

9 Participants
are divided into 3 treatment groups

Sponsors and collaborators