tSCS + UL Robotics Training in SCI Patients

ConditionSpinal Cord Injuries

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-80

SponsorNational University Hospital, Singapore

About this trial

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.

Eligibility criteria

Qualifiers

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,

Disqualifiers

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.

Trial design

Treatments tested in this trial

ULRT + tSCS + conventional occupational therapy
ULRT + conventional occupational therapy

Treatment groups

6 Participants

are divided into 2 treatment groups

Sponsors and collaborators

National University Hospital, Singapore

Lead sponsor

Alexandra Hospital

Collaborator

Source ClinicalTrials.gov