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

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ClinicalTrials.gov Identifier: NCT03477123
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2018
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Institut Guttmann
Information provided by (Responsible Party):
Angel Gil-Agudo, Hospital Nacional de Parapléjicos de Toledo

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Incomplete Spinal Cord Injury Device: Walking therapy with Exo-H2 exoskeleton Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The evaluator does not have information on the group the patient was enrolled.
Primary Purpose: Treatment
Official Title: Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.


  7. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477123


Locations
Spain
National Hospital for Paraplegics
Toledo, Spain, 45071
Sponsors and Collaborators
Hospital Nacional de Parapléjicos de Toledo
Institut Guttmann
Investigators
Study Chair: Angel Gil-Agudo, PhD, MD Head of Rehabilitation Department

Publications:

Responsible Party: Angel Gil-Agudo, PhD, MD, Head of Rehabilitation, Hospital Nacional de Parapléjicos de Toledo
ClinicalTrials.gov Identifier: NCT03477123     History of Changes
Other Study ID Numbers: PI15/01437
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Angel Gil-Agudo, Hospital Nacional de Parapléjicos de Toledo:
Incomplete spinal cord injury
Walking
Rehabilitation
Robotic exoskeleton

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System