Status:

COMPLETED

Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury.

Lead Sponsor:

Hospital Nacional de Parapléjicos de Toledo

Collaborating Sponsors:

Institut Guttmann

Conditions:

Spinal Cord Injury

Incomplete Spinal Cord Injury

Eligibility:

All Genders

16-70 years

Phase:

NA

Brief Summary

The objective of the study is to assess the efficacy of the Exo-H2 robotic exoskeleton for walking rehabilitation of people with incomplete spinal cord injury.

Detailed Description

The recovery of walking ability is a primary concern of rehabilitation programs for people who have suffered anincomplete spinal cord injury. Robotic therapy arises from the new concepts of neuroplast...

Eligibility Criteria

Inclusion

  • Incomplete Spinal Cord Syndrome, ASIA scale C or D
  • enough strength in the upper extremities to handle a walker or crutches (triceps brachial muscle balance ≥ 3)
  • Age between 16 and 70 y.o.
  • Heigth: 1.6-1.9m
  • Weigth less than 120Kg
  • Stable medical condition between 6 weeks and 18 months since injury.
  • Subjects must tolerate standing and be included in walking rehabilitation program in the center.
  • Lower limb spasticity should be lower than 3 as measyred by Ashworth scale.

Exclusion

  • Cardiovascular diseases.
  • Upper limb pathology of any kind.
  • irreducible flexo or arthrodesis in lower limb joints, 2 or more osteoporotic fractures in the lower limbs in the last 2 years
  • Uncontrolled epilepsy.
  • Ulcers sores at the contact points with the exoskeleton.
  • Refuse to participate.

Key Trial Info

Start Date :

January 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 3 2020

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT03477123

Start Date

January 1 2016

End Date

July 3 2020

Last Update

July 7 2020

Active Locations (1)

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1

National Hospital for Paraplegics

Toledo, Spain, 45071