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

July 3, 2020 updated by: Angel Gil-Agudo, Hospital Nacional de Parapléjicos de Toledo

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

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.

Study Overview

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 neuroplasticity. One of the most novel contributions in this field is robotic exoskeletons. However, there is still not enough scientific evidence to support the clinical use of this technology.

The aim of this proposal is to assess the efficacy of a new model of robotic exoskeleton (Exo H2) developed by the CSIC with HNP involvement in the context of HYPER project (Consolider 2009 call) in gait rehabilitation for people with incomplete spinal cord injury. A multicenter study is proposed here, involving the National Hospital of Paraplegics and the Institut Guttmann. Two randomized groups of patients with subacute incomplete spinal cord injury will be defined. In one group, protocol gait rehabilitation based on the Exo H2 will be established and traditional gait therapy will be adapted for control group. Both groups of patients were assessed performing a physical exam including functional gait scales (10 MWT, 6MWT, WISCI II score, SCIM) and a biomechanical gait analysis with kinetic and kinematic techniques. Functional assessment will be carried out before intervention, at the end of the intervention and a follow up six weeks later.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toledo, Spain, 45071
        • National Hospital for Paraplegics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Walking therapy with Exo-H2 exoskeleton
No Intervention: Control
Group receiving conventional walking therapy without robotic exoskeleton

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower extremity motor score
Time Frame: Change from Baseline Lower Extremity Motor Score at 2 months
This scale evaluate the ability and force of the patient when attepmting to contract five key lower limb muscles. It is manually measured by the therapist. Range from 0 (no contraction) to 5 (healthy function). The total score summs up the scores of all muscles. In healthy conditions is 50 points.
Change from Baseline Lower Extremity Motor Score at 2 months
Spasticity measured by Ashworth scale
Time Frame: Change from Baseline Ashworth Scale at 2 months
Manual testing of muscle tone in response to manual mobilization of joints. Range from 0 (healthy response) to 4 (maximum muscle tone).
Change from Baseline Ashworth Scale at 2 months
Ten meters walking test
Time Frame: Change from Baseline Ten Meters Walking Test at 2 months
This test measure walking velocity on covering ten meters walking in flat, straigth line.
Change from Baseline Ten Meters Walking Test at 2 months
Six minutes walking test
Time Frame: Change from Baseline Six Minutes Walking Test at 2 months
This test measure walking endurance by measuring the distance covered in six minutes of walking in flat, straigth line.
Change from Baseline Six Minutes Walking Test at 2 months
Time Up-and-Go Test (TUG)
Time Frame: Change from Baseline TUG Test at 2 months
This test measures the time to complete stand to sit, walk 3 meters and sitting back again.
Change from Baseline TUG Test at 2 months
Walking Index for Spinal Cord Injury II (WISCI II)
Time Frame: Change from Baseline WISCI II Scale at 2 months

WISCI II assess the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from Spinal Cord Injury.

The subject is observed by the trained personnel and the WISCI level is recorded on the scale of 0 to 20 at baseline (Baseline WISCI). The subject is observed again at the defined interval (Interval WISCI). The change in score is calculated by subtracting the baseline WISCI from the Interval WISCI, which equals the change in WISCI (Changed WISCI). If a group of subjects are enrolled, medians and means may be calculated.

Change from Baseline WISCI II Scale at 2 months
Questionnaire: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time Frame: Through study completion
The purpose of the QUEST questionnaire is to evaluate how satisfied you are with your assistive device and the related services you experienced. The questionnaire consists of 12 satisfaction items. For each of the 12 items, rate your satisfaction with your assistive device and the related services you experienced by using the following scale of 1 to 5.
Through study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal Cord Independence Measure III (SCIM III)
Time Frame: Change from Baseline SCIM III scale at 2 months
The SCIM is composed of 19 items that assess 3 domains.1) Self-care, 2) Respiration and sphincter management, 3) Mobility (9 items, scores range from 0-40). The total SCIM scores range from 0 to 100.
Change from Baseline SCIM III scale at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Angel Gil-Agudo, PhD, MD, Head of Rehabilitation Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

July 3, 2020

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 3, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injury

Clinical Trials on Walking therapy with Exo-H2 exoskeleton

3
Subscribe