Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI

Recruiting now · Not applicable

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT05921175

Run by

National University Hospital, Singapore

People needed

6

Starts

2024-11-13

Expected to finish

2026-09-01

Last updated by the study team

2026-02-23

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 6 months to 5 years from the diagnosis of the traumatic SCI and who are not walking independently;
• Age between 21 to 65 years old;
• Incomplete spinal cord injury: ASIA Impairment Scale (AIS) Grade: B-D;
• Spinal cord injury level: T1- L1, or C2-C8;
• SCI-TCT Score > 13;
• Capable of providing an informed consent;
• Cleared by Neurosurgeons/ Orthopeadic Surgeons for tSCS;
• Meets prerequisites for Ekso wearable robotic exoskeleton training.

You may not qualify if…

• Participant has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the investigator;
• Participant has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound performance and outcomes like uncontrolled neuropathic pain, depression, severe cognitive impairment;
• Unstable or uncontrolled autonomic dysreflexia;
• Requires ventilator support;
• Spasms that limit the ability of the subjects to participate in the study training as determined by the investigator;
• Skin conditions that limit the application of tSCS electrodes;
• Active implanted medical devices that may be affected by tSCS;
• Pregnant, planning to become pregnant or breastfeeding;
• Concurrent participation in another drug or device trial that may interfere with this study;
• Participated in wearable exoskeleton training within the last 3 months prior to enrolment.
• Peripheral nerve injury or significant Lumbar Radiculopathy

Where it is running

• Alexandra Hospital — Singapore, Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

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