Health Condition 1: S240- Concussion and edema of thoracic spinal cord
Conditions
Interventions
Intervention1: REARS device (Robotic exoskeletion): Gait training with robotic exoskeleton will be done in persons with spinal cord injury
Control Intervention1: NIL: NIL
Sponsors
International Institute of Information Technology Bengaluru
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women with Spinal Cord Injury (SCI) aged between 18 - 60 years with paraplegia or tetraplegia, sub-acute or chronic ( > 3 week after the injury). Non-traumatic SCI will also be included, given they have neurologically stable conditions. 2. Sufficient diaphragmatic strength (>= 30 single breath count) such that respiration is not compromised with exercise. 3. AIS-C SCI & AIS-D SCI (motor incomplete), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI). 4. No history of other neurological conditions. 5. Weight 90kg or less. 6. Be able to fit into the REARS device. 7. Height between approximately 5 feet and 6 feet 8. Willing to give an informed consent
Exclusion criteria
Exclusion criteria: 1. AIS-A & AIS-B spinal cord injury patients 2. Lower motor neuron injuries 3. Currently involved in another interventional study 4. DEXA results indicating a t-score below -2.5 at the lumbar spine and proximal femur 5. Uncontrolled or severe orthostatic hypotension that limits standing tolerance; defined as sustained, symptomatic drops in systolic and diastolic (>= 20 mm Hg systolic, >= 10 mm Hg diastolic) blood pressure when moving from sitting to standing 6. Active heterotopic ossification (HO) 7. Contractures at the hip or knee preventing standing, hip dysplasia or hip / knee axis abnormalities 8. Unresolved deep vein thrombosis 9. Uncontrolled autonomic dysreflexia 10. Severe muscular or skeletal pain. 11. Active systemic or peripheral infection 12. Open skin ulcerations in the sacral / trochanteric region or other body surfaces which will come in contact with exoskeleton or harness 13. Pregnancy 14. Cognitive impairments â?? unable to follow 2 steps commands and communicate for pain or to stop session 15. History of recent myocardial infarction ( 16. Colostomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 10 Meter Walk Test 2. 6 Minute Walk Test 3. 2 Minute Walk Test 4. TUG (Timed up and go test) 5. Walking Index for Spinal Cord Injury (WISCI-II) 7. SCIM (Spinal Cord Independence Measure) - IIITimepoint: At baseline (2nd session) and midpoint (12th session of training) and endpoint (24th session of training) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of falls during training sessions, during donning or doffing procedure or transfers 2. Incidence of skin breakdown (abrasion/rash/ulcer) or any bony injury during training sessions 3. Pain during training 4. Device malfunction (if any) will be recorded 5. Vitals (Heart rate, Blood pressure and SpO2) before, during and after training session.Timepoint: Recorded throughout the study. The adverse effects (if they occur) will be recorded;1. Spasticity & Spasms (Modified Ashworthâ??s Scale) 2. Muscle Strength (Manual Muscle Testing-MMT) 3. Sleep Cycle (Pittsburg Sleep Quality Index-PSQI)Timepoint: At baseline (2nd session) and midpoint (12th session of training) and endpoint (24th session of training);A. Duration of therapy (training time, number of steps taken) B. Distance walked with exoskeleton C. Time to don / doff the exoskeleton and harnessTimepoint: These are recorded throughout the study period (during training session);Performance of the REARS in terms of the function of the REARS (Robotic exoskeleton) will be evaluated through patient feedbackTimepoint: At the start and end of study | — |
Countries
India
Contacts
Public ContactAnupam Gupta
National Institute of Mental Health and Neurosciences
Outcome results
None listed