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RECRUITING
NCT07432321
NA

tSCS + UL Robotics Training in SCI Patients

Sponsor: National University Hospital, Singapore

View on ClinicalTrials.gov

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.

Official title: A Pilot Study on the Cumulative Effects of Transcutaneous Spinal Cord Stimulation (tSCS) With Upper Limb Robotics Training in Upper Limb Rehabilitation in Patients With Tetraplegic Spinal Cord Injury

Key Details

Gender

All

Age Range

21 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2025-09-18

Completion Date

2027-09-30

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DEVICE

ULRT + tSCS + conventional occupational therapy

Subject will undergo 16 sessions of Upper limb robotics training (ULRT) + tSCS+ conventional occupational therapy, 2 sessions a week for 8-10 weeks. Participants will use either H-Man arm rehabilitation robot or Esoglove™ PRO hand rehabilitation system, or both according to their functional impairment for ULRT. Participants will undergo conventional occupational therapy as prescribed by the attending occupational therapist based on their assessment. During tSCS, cathodes will be placed on the T11 and L1 spinous process. Reference/Ground electrodes placed over the ASIS. It will be on biphasic mode with a stimulation delivered at 30-50 Hz with a 10-kHz carrier frequency overlay, which consisted of 10 pulses with a 10-kHz frequency and 100-µs pulse width.Stimulation intensity ranges from 5-100 mA and will be adjusted according to the patient's response.The tSCS stimulation duration for each session will be 45 minutes in conjunction with the ULRT training.

DEVICE

ULRT + conventional occupational therapy

Participants will undergo 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks. Participants will use either H-Man arm rehabilitation robot or Esoglove™ PRO hand rehabilitation system, or both according to their functional impairment for ULRT. Participants will undergo conventional occupational therapy as prescribed by the attending occupational therapist based on their assessment.

Locations (1)

Alexandra Hospital

Singapore, Singapore, Singapore