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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

9 Participants
are divided into 3 treatment groups
Group A: Group 1 (intervention at end of Week 4)Other 1 intervention
Group B: Group 2 (intervention at end of Week 10)Other 1 intervention
Group C: Group 3(intervention at end of Week 16)Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Every 2 weeks for total 22 weeks to collect up to 12 data points

Secondary outcomes

1

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.

Time frame
Every 2 weeks for total 22 weeks to collect up to 12 data points
2

Quality of Life (QoL)

EQ-5D-5L, where there are 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems

Time frame
Every 2 weeks for total 22 weeks to collect up to 12 data points
3

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)

Time frame
Before Week 0 and after the end of Week 22
4

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.

Time frame
After the end of Week 22

Other outcomes

Sponsors and contacts

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