An interventional study of Walking therapy with Exo-H2 exoskeleton in Spinal Cord Injury and Incomplete Spinal Cord Injury, sponsored by Hospital Nacional de Parapléjicos de Toledo. Completed at 1 site in Spain. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Hospital Nacional de Parapléjicos de Toledo · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Walking therapy with Exo-H2 exoskeleton
Device: Walking therapy with Exo-H2 exoskeleton
Group receiving conventional walking therapy without robotic exoskeleton
Lower extremity motor score
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.
Time frame: Change from Baseline Lower Extremity Motor Score at 2 months
Spasticity measured by Ashworth scale
Manual testing of muscle tone in response to manual mobilization of joints. Range from 0 (healthy response) to 4 (maximum muscle tone).
Time frame: Change from Baseline Ashworth Scale at 2 months
Ten meters walking test
This test measure walking velocity on covering ten meters walking in flat, straigth line.
Time frame: Change from Baseline Ten Meters Walking Test at 2 months
Six minutes walking test
This test measure walking endurance by measuring the distance covered in six minutes of walking in flat, straigth line.
Time frame: Change from Baseline Six Minutes Walking Test at 2 months
Time Up-and-Go Test (TUG)
This test measures the time to complete stand to sit, walk 3 meters and sitting back again.
Time frame: Change from Baseline TUG Test at 2 months
Walking Index for Spinal Cord Injury II (WISCI II)
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.
Time frame: Change from Baseline WISCI II Scale at 2 months
Questionnaire: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
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.
Time frame: Through study completion
Spinal Cord Independence Measure III (SCIM III)
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.
Time frame: Change from Baseline SCIM III scale at 2 months
Plan to share: No
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Hospital Nacional de Parapléjicos de Toledo