RecruitingNot Applicable

Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI

Singapore6 participantsStarted 2024-11-13

Plain-language summary

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.

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

Spinal Cord Injury - Trunk Control Test (SCI-TCT)

Timeframe: Week 0

Spinal Cord Injury - Trunk Control Test (SCI-TCT)

Timeframe: Week 8

Spinal Cord Injury - Trunk Control Test (SCI-TCT)

Timeframe: Week 17

Walking Index in Spinal Cord Injury-II (WISCI-II)

Timeframe: Week 0

Walking Index in Spinal Cord Injury-II (WISCI-II)

Timeframe: Week 8

Walking Index in Spinal Cord Injury-II (WISCI-II)

Timeframe: Week 17

10-Meter Walk Test (10MWT)

Timeframe: Week 0

10-Meter Walk Test (10MWT)

Timeframe: Week 8

10-Meter Walk Test (10MWT)

Trial details

NCT IDNCT05921175

SponsorNational University Hospital, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Gobinathan Chandran, MBBS

(65) 94575924 Gobinathan_CHANDRAN@nuhs.edu.sg

View on ClinicalTrials.gov More Spinal Cord Injury trials

Plain-language summary

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

Spinal Cord Injury - Trunk Control Test (SCI-TCT)

Timeframe: Week 0

Spinal Cord Injury - Trunk Control Test (SCI-TCT)

Timeframe: Week 8

Spinal Cord Injury - Trunk Control Test (SCI-TCT)

Timeframe: Week 17

Walking Index in Spinal Cord Injury-II (WISCI-II)

Timeframe: Week 0

Walking Index in Spinal Cord Injury-II (WISCI-II)

Timeframe: Week 8

Walking Index in Spinal Cord Injury-II (WISCI-II)

Timeframe: Week 17

10-Meter Walk Test (10MWT)

Timeframe: Week 0

10-Meter Walk Test (10MWT)

Timeframe: Week 8

10-Meter Walk Test (10MWT)