RecruitingNot Applicable

tSCS + UL Robotics Training in SCI Patients

Singapore6 participantsStarted 2025-09-18

Plain-language summary

This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment upper limb robotic training (ULRT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluates the impact of the tSCS+ULRT on health-related quality of life (HRQOL), compared to ULRT alone. This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 to 8 subjects with C2-8 level injuries will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of ULRT training + tSCS + conventional occupational therapy in 8-10 weeks. Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1, Post-Phase 2, and 4 weeks Follow-up. A satisfaction survey on the intervention "ULRT training + tSCS + conventional physiotherapy" will be performed at end of the study.

Who can participate

Age range21 Years – 80 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

✓. At least 6 months to 5 years from the diagnosis of the traumatic SCI;
✓. Participants between 21 and 80 years of age;
✓. C2-8 level injuries;
✓. ISNCSCI-UEMS \>25,
✓. Pinch force \> 25 N;
✓. Grasp force \> 100 N;
✓. Able to perform the box and block test;
✓. Sitting tolerance for at least 1 hour (No known postural hypotension issues or pressure intolerance);

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

GRASSP 2

Timeframe: Week 0

GRASSP 2

Timeframe: Week 8

GRASSP 2

Timeframe: Week 16

GRASSP 2

Timeframe: Week 20

International standards for Neurological Classification of SCI (ISNCSCI)

Timeframe: Week 0

International standards for Neurological Classification of SCI (ISNCSCI)

Timeframe: Week 8

International standards for Neurological Classification of SCI (ISNCSCI)

Timeframe: Week 16

International standards for Neurological Classification of SCI (ISNCSCI)

Timeframe: Week 20

Central motor conduction time (CMCT)

Trial details

NCT IDNCT07432321

SponsorNational University Hospital, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Gobinathan Chandran, MBBS

(65) 94575924 Gobinathan_CHANDRAN@nuhs.edu.sg

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range21 Years – 80 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

✓. At least 6 months to 5 years from the diagnosis of the traumatic SCI;
✓. Participants between 21 and 80 years of age;
✓. C2-8 level injuries;
✓. ISNCSCI-UEMS \>25,
✓. Pinch force \> 25 N;
✓. Grasp force \> 100 N;
✓. Able to perform the box and block test;
✓. Sitting tolerance for at least 1 hour (No known postural hypotension issues or pressure intolerance);

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

GRASSP 2

Timeframe: Week 0

GRASSP 2

Timeframe: Week 8

GRASSP 2

Timeframe: Week 16

GRASSP 2

Timeframe: Week 20

International standards for Neurological Classification of SCI (ISNCSCI)

Timeframe: Week 0

International standards for Neurological Classification of SCI (ISNCSCI)

Timeframe: Week 8

International standards for Neurological Classification of SCI (ISNCSCI)

Timeframe: Week 16

International standards for Neurological Classification of SCI (ISNCSCI)

Timeframe: Week 20

Central motor conduction time (CMCT)