CTRI/2020/10/028328
Not Yet Recruiting
Phase 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 enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- International Institute of Information Technology Bengaluru
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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
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.
Outcomes
Primary Outcomes
Not specified
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