Status:

UNKNOWN

Effects of Ambulation Training Utilizing an Exoskeleton Robot on Subjects With Spinal Cord Injury

Lead Sponsor:

China Medical University Hospital

Conditions:

Spinal Cord Injuries

Eligibility:

All Genders

20-65 years

Phase:

NA

Brief Summary

The present study aims to investigate the effects of ReWalk exoskeleton robot training on various physiological and psychological parameters among subjects with spinal cord injury, including body comp...

Detailed Description

The loss of upright mobility has a profound effect on the health and quality of life for individuals with a spinal cord injury (SCI). The ReWalk exoskeleton is an FDA-cleared, wearable, computer-contr...

Eligibility Criteria

Inclusion

  • Between the age of 20-65 years old;
  • Have paraplegia resulting from thoracic or lumbar spinal cord injury.
  • At least 6 months after onset of the spinal cord injury
  • Well motivated and willing to participate 40 hours of ReWalk ambulation training sessions.

Exclusion

  • Have spinal cord injury neurologic level above T4
  • Height greater than 190 cm or lower than160 cm
  • Weight greater than 100 kg
  • Have osteoporosis (T-score \< -2.5)
  • Deep vein thrombosis
  • Severe orthostatic hypotension precluding standing and walking training
  • Pregnancy
  • Cognitive impairments that would impact on the safe participation in the study
  • Severe spasticity of lower limbs (Modified Ashworth Scale \>3)
  • Contracture of the ankle, or a knee flexion contracture greater than 10 degrees
  • Musculoskeletal conditions that affected gait capacity
  • Co-existence of other neurological diseases

Key Trial Info

Start Date :

November 23 2017

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2019

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT03340792

Start Date

November 23 2017

End Date

December 31 2019

Last Update

January 8 2018

Active Locations (1)

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China Medical University Hospial

Taichung, Taiwan, 404