The study of walking after training with robotic exoskeletion in persons with incomplete spinal cord injury

Phase 2

Not yet recruiting

Conditions: Health Condition 1: S240- Concussion and edema of thoracic spinal cord

Registration Number: CTRI/2020/10/028328

Lead Sponsor: International Institute of Information Technology Bengaluru

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. 10 Meter Walk Test <br/ ><br>2. 6 Minute Walk Test <br/ ><br>3. 2 Minute Walk Test <br/ ><br>4. TUG (Timed up and go test) <br/ ><br>5. Walking Index for Spinal Cord Injury (WISCI-II) <br/ ><br>7. SCIM (Spinal Cord Independence Measure) - IIITimepoint: At baseline (2nd session) and midpoint (12th session of training) and endpoint (24th session of training)

Secondary Outcome Measures