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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Home-based digital rehabilitation programme with tSCS
DeviceHome-based digital rehabilitation programme with tSCS introduced at staggered time points following varying duration of baseline usual care
Treatment groups
Trial outcomes
Primary outcomes
Upper limb function
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP), from a scale of 0 to 3 or 0 to 5, where a higher number indicate better outcome.
Secondary outcomes
Upper limb strength
Upper Extremity Measurement Scale, from a scale of 0 to 2 or 0 to 5, where a higher number indicate better outcome.
Quality of Life (QoL)
EQ-5D-5L, where there are 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems
Rehabilitation goals achievement
Goal attainment scale (GAS), which measures whether a goal was achieved or not (yes or no) and to what extent (yes = much better, a little better, as expected, no = partially achieved, same as baseline, worse)
Participants and care givers feedback on the appropriateness, acceptability, and feasibility of the programme
In-depth interviews to explore the perspectives of patient and caregiver participating in the program.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: