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
Home-based digital rehabilitation programme with tSCS
Home-based digital rehabilitation programme with tSCS: Home-based digital rehabilitation programme with tSCS introduced at staggered time points following varying duration of baseline usual care
Study summary
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
Sex
ALL
Min age
21 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
Participant
* 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;
* At least one hand capable of grasp and pinch, with or without assistive modification;
* International Standards for Neurological Classification of Spinal Cord Injury-Upper Extremity Measurement Scale (ISNCSCI-UEMS) more than or equal to 20;
* Able to maintain an upright sitting position for at least 30 minutes;
* No contraindication for tSCS (e.g., no pacemakers or other implantable stimulators);
* Motivated and able to engage in a daily home-based rehabilitation program;
* Availability of a dedicated care-giver to set up digital home-based therapy program
Caregiver
* Age 21 -75 years;
* As identified by the patient as the caregiver;
* Willing to participate in the study
Exclusion Criteria:
Participant
* 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);
* Ongoing treatment for cancer;
* Skin conditions or active cancerous lesion that limit the application of tSCS electrodes
* Known contraindication for tSCS (pacemakers or other implantable stimulators);
* Prior exposure to tSCS treatment;
* Inability to provide informed consent.
Caregiver:
• Inability to provide informed consent.
Primary outcome measure(s)
Upper limb function — Every 2 weeks for total 22 weeks to collect up to 12 data points 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.
Trial sites (1)
Facility
City
Region
Status
Singapore General Hospital
Singapore
Singapore
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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