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Clinical Trials/PACTR201608001647143
PACTR201608001647143
Not Yet Recruiting
N/A

The effect of robotic exoskeleton gait rehabilitation on individuals with chronic spinal cord injury

niversity of Cape Town0 sites48 target enrollmentMay 21, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Nervous System Diseases
Sponsor
niversity of Cape Town
Enrollment
48
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 21, 2016
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Cape Town

Eligibility Criteria

Inclusion Criteria

  • ¿Male or female individuals with a SCI (traumatic)
  • ¿18 through to 65 years old
  • ¿English speaking (Does not need to be 1st language but must be fluent)
  • ¿Chronic (\>1yr) spinal cord injury
  • ¿Motor/Sensory incomplete (AIS B, C, D), with a neurological level of injury (NLI) between C1\-C8 as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
  • ¿Reliant upon a wheelchair as their primary mode of mobility
  • ¿Sufficient anthropometrics and range of motion (ROM) to achieve a normal, reciprocal gait pattern within the EksoTM suit
  • oStanding height: 157cm ¿ 188cm
  • oMaximum hip width: 42cm
  • oUpper leg length (Femur): 51cm to 61\.4cm

Exclusion Criteria

  • ¿Non\-traumatic SCI
  • ¿Have trained in a robotic exoskeleton in the past
  • ¿Performing any other form of locomotor training
  • ¿Clinically Depressed (Beck Depression Inventory)
  • ¿Any medical issue that in the opinion of the investigator precludes full weight bearing locomotor training including but not limited to:
  • oHeart or respiratory comorbidity
  • oSpinal instability (or spinal orthotic unless cleared by physician)
  • oAcute deep vein thrombosis (DVT) with activity restrictions
  • oSevere, recurrent autonomic dysreflexia (AD) requiring medical intervention
  • oHeterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees

Outcomes

Primary Outcomes

Not specified

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