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tSCS + UL Robotics Training in SCI Patients

RecruitingNAAges 21 Years - 80 YearsAllNational University Hospital, Singapore
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. At least 6 months to 5 years from the diagnosis of the traumatic SCI; 2. Participants between 21 and 80 years of age; 3. C2-8 level injuries; 4. ISNCSCI-UEMS \>25, 5. Pinch force \> 25 N; 6. Grasp force \> 100 N; 7. Able to perform the box and block test; 8. Sitting tolerance for at least 1 hour (No known postural hypotension issues or pressure intolerance); 9. Capable of providing an informed consent; 10. Cleared by Neurosurgeons/Orthopaedic Surgeon for tSCS; Exclusion Criteria: 1. Participant has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the investigator. 2. 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. 3. Unstable or uncontrolled autonomic dysreflexia. 4. Requires ventilator support. 5. Spasms that limit the ability of the subjects to participate in the study training as determined by the investigator. 6. Has an autoimmune etiology of spinal cord dysfunction/injury 7. History of additional neurologic disease, such as stroke, multiple sclerosis and traumatic brain Injury. 8. Pain in shoulder and/or hand which will be inhibitory towards rehabilitative therapy. 9. Severe Upper limb contractures. 10. Acute Medical conditions to Upper limb (ie Fractures that would limit ROM and/or weightbearing). 11. Participants who are pregnant.
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What it tests

  • ULRT + tSCS + conventional occupational therapy
  • ULRT + conventional occupational therapy
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Where

1 site
Alexandra Hospital
Singapore, Singapore
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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