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.
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;
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;
National University Hospital, Singapore
Lead sponsor
Alexandra Hospital
Collaborator