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Completed

NCT Number: NCT03477123

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Incomplete Spinal Cord Injury Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital for Paraplegics

Toledo, 45071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Walking therapy with Exo-H2 exoskeleton

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Nacional de Parapléjicos de Toledo

Other

Collaborators

  • Institut Guttmann

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2018
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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