CTRI/2020/10/028328Not yet recruitingPhase 2
Gait training with Exoskeletal Robot in patients with incompletespinal cord injury and its effect on locomotion: A prospective pre-post study
International Institute of Information Technology Bengaluru0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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 ( < 6 months) or uncontrolled cardiac arrhythmia
- •16. Colostomy
Investigators
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