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 (HOPE)

February 22, 2026 updated by: Singapore General Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Spinal Cord Injury (SCI), resulting from trauma or other causes, is a debilitating condition characterized by damage to the spinal cord. It leads to profound and often irreversible impairments in motor, sensory, and autonomic function, resulting in substantial limitations in activities of daily living (ADLs) and ambulation. These impairments significantly impair quality of life (QoL) and often result in long-term healthcare dependence. Globally, SCI affects approximately 20.6 million individuals, with an estimated 0.9 million new cases reported annually. In Singapore, the prevalence of SCI increased from 5 to 6 per 100,000 in 1990 to an estimated 13 to 15 per 100,000 in 2019. The economic burden is substantial, with annual direct costs related to SCI exceeding US$45 billion in the United States alone.

Among SCI types, incomplete tetraplegia is the most prevalent, accounting for 47.1% of all cases. This is reflected in local data; a study reported 44 new surgically treated SCI cases admitted to Singapore General Hospital (SGH) and Changi General Hospital (CGH) between January 2020 to December 2021, of which 39 were cervical SCI. Another local epidemiology study found that 75% of 55 traumatic SCI cases were tetraplegic.

For individuals with tetraplegia, upper limb function is often severely compromised, significantly limiting independence in daily tasks and impacting overall QoL. Restoration of hand and arm function is regarded as the top rehabilitation priority, considered six times more important than restoring walking ability in this group of population. A survey done by Snoek et al, 77% of 565 individuals with tetraplegia identified improvement in hand function as a key factor in improving their QoL.

Spinal cord stimulation (SCS) has emerged as a promising neuromodulation technique for improving neurological function after SCI. SCS delivers electrical impulses to activate afferent fibers, enhancing interneuronal connections between sensory afferents and motor neurons, enhancing motor neuron excitability, and promoting communication between spinal network. Transcutaneous spinal cord stimulation (tSCS), a non-invasive form of SCS, has gained significant attention, with numerous studies examining its effectiveness in improving motor function following SCI. tSCS typically involves the application of active electrodes over the cervical spinal region (C3/4 and C6/7) and return electrodes over the anterior superior iliac spine (ASIS), and it is combined with in-clinic rehabilitation or home-based exercise to enhance its therapeutic effect. Recent clinical trials have demonstrated that tSCS significantly improves upper limb function in individuals with chronic tetraplegia. For instance, the Up-LIFT trial enrolled 60 participants with nonprogressive incomplete cervical SCI. After 12-20 sessions of tSCS therapy, 72% of participants demonstrated improvements greater than the minimally important difference for both strength and functional domains. Notably, the tSCS demonstrated a favorable safety profile, even for home use.

To address these gaps, a commercially available neuromuscular electrical stimulation (NMES) devices, such as HSA-approved NeuroTrac® MultiTENS, offer a potential alternative. These devices can deliver similar stimulation parameters at a fraction of the cost. Despite differences in stimulation parameters such as pulse width and carrier frequency, the NeuroTrac® MultiTENS has demonstrated a profile that appears safe and effective in managing SCI-related complications .

This prospective, open-label study investigates a home-based rehabilitation program by repurposing a commercially available, HSA-approved neuromuscular electrical stimulation (NMES) device to deliver tSCS. The intervention integrates daily tSCS with a structured, mobile application-guided upper limb exercise program delivered through an AI-enabled digital platform that provides instructional content, real-time movement feedback, and adherence monitoring. Caregivers assist participants with device setup and therapy execution following standardized training.

The study employs a single-case experimental design with multiple baselines across participants. A total of 9 to 30 individuals with chronic, non-progressive cervical SCI (AIS B, C, or D) and impaired upper limb function will be enrolled and randomized into three groups. Each group will begin the intervention after a different baseline duration, allowing participants to serve as their own controls. All participants will complete a total study duration of 22 weeks, with the intervention lasting between 6 and 18 weeks depending on group assignment.

The primary outcome is upper limb function, assessed using the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP), measured every two weeks throughout the study. Secondary outcomes include upper extremity motor strength, quality of life, and goal attainment. Feasibility outcomes include adherence to the home-based program and participant and caregiver acceptability. Safety outcomes include monitoring and documentation of all adverse events related to tSCS and home-based therapy.

The results of this study will provide early evidence on the safety, feasibility, and potential efficacy of a scalable, home-based neuromodulation rehabilitation model using commercially available technology for individuals with tetraplegia.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: 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
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
Device: 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
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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper limb function
Time Frame: 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.
Every 2 weeks for total 22 weeks to collect up to 12 data points

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper limb strength
Time Frame: Every 2 weeks for total 22 weeks to collect up to 12 data points
Upper Extremity Measurement Scale, from a scale of 0 to 2 or 0 to 5, where a higher number indicate better outcome.
Every 2 weeks for total 22 weeks to collect up to 12 data points
Quality of Life (QoL)
Time Frame: Every 2 weeks for total 22 weeks to collect up to 12 data points
EQ-5D-5L, where there are 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems
Every 2 weeks for total 22 weeks to collect up to 12 data points
Rehabilitation goals achievement
Time Frame: Before Week 0 and after the end of Week 22
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)
Before Week 0 and after the end of Week 22
Participants and care givers feedback on the appropriateness, acceptability, and feasibility of the programme
Time Frame: After the end of Week 22
In-depth interviews to explore the perspectives of patient and caregiver participating in the program.
After the end of Week 22
Home therapy adherence
Time Frame: Every 2 weeks for total 22 weeks to collect up to 12 data points
Usage data from mobile application (duration of therapy and accuracy of performance)
Every 2 weeks for total 22 weeks to collect up to 12 data points
Safety monitoring
Time Frame: Every 2 weeks for total 22 weeks to collect up to 12 data points
All adverse events (autonomic dysreflexia, skin irritation, back pain, muscle soreness, fatigue, spasms etc)
Every 2 weeks for total 22 weeks to collect up to 12 data points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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