Actively Recruiting
Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI
Led by National University Hospital, Singapore · Updated on 2026-02-23
6
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
A
Alexandra Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment robotic gait training (RGT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluate the impact of the tSCS+RGT on health-related quality of life (HRQOL), compared to RGT alone. This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with paraplegia and 6 subjects with tetraplegia will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of RGT training + tSCS + conventional physiotherapy in 8-10 weeks. Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1 and Post-Phase 2. A satisfaction survey on the intervention "RGT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.
CONDITIONS
Official Title
Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 6 months to 5 years from the diagnosis of the traumatic spinal cord injury and not walking independently
- Age between 21 to 65 years old
- Incomplete spinal cord injury: ASIA Impairment Scale Grade B-D
- Spinal cord injury level: C2-C8 or T1-L1
- Spinal Cord Injury Trunk Control Test (SCI-TCT) Score greater than 13
- Able to provide informed consent
- Cleared by neurosurgeons or orthopedic surgeons for transcutaneous spinal cord stimulation
- Meets requirements for Ekso wearable robotic exoskeleton training
You will not qualify if you...
- Uncontrolled cardiopulmonary disease or cardiac symptoms
- Unstable or significant medical conditions interfering with study or affecting outcomes, such as uncontrolled neuropathic pain, depression, or severe cognitive impairment
- Unstable or uncontrolled autonomic dysreflexia
- Requires ventilator support
- Spasms limiting ability to participate in training
- Skin conditions preventing application of tSCS electrodes
- Active implanted medical devices that may be affected by tSCS
- Pregnant, planning pregnancy, or breastfeeding
- Participating in another drug or device trial that may interfere with this study
- Participated in wearable exoskeleton training within 3 months prior to enrollment
- Peripheral nerve injury or significant lumbar radiculopathy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Alexandra Hospital
Singapore, Singapore, Singapore, 159964
Actively Recruiting
Research Team
G
Gobinathan Chandran, MBBS
CONTACT
N
Ning Tang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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