- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03477123
Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury.
Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete Spinal Cord Injury
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Toledo, Spain, 45071
- National Hospital for Paraplegics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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No Intervention: Control
Group receiving conventional walking therapy without robotic exoskeleton
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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
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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.
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Change from Baseline Lower Extremity Motor Score at 2 months
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Spasticity measured by Ashworth scale
Time Frame: Change from Baseline Ashworth Scale at 2 months
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Manual testing of muscle tone in response to manual mobilization of joints.
Range from 0 (healthy response) to 4 (maximum muscle tone).
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Change from Baseline Ashworth Scale at 2 months
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Ten meters walking test
Time Frame: Change from Baseline Ten Meters Walking Test at 2 months
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This test measure walking velocity on covering ten meters walking in flat, straigth line.
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Change from Baseline Ten Meters Walking Test at 2 months
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Six minutes walking test
Time Frame: Change from Baseline Six Minutes Walking Test at 2 months
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This test measure walking endurance by measuring the distance covered in six minutes of walking in flat, straigth line.
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Change from Baseline Six Minutes Walking Test at 2 months
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Time Up-and-Go Test (TUG)
Time Frame: Change from Baseline TUG Test at 2 months
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This test measures the time to complete stand to sit, walk 3 meters and sitting back again.
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Change from Baseline TUG Test at 2 months
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Walking Index for Spinal Cord Injury II (WISCI II)
Time Frame: Change from Baseline WISCI II Scale at 2 months
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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
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Questionnaire: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time Frame: Through study completion
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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.
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Through study completion
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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
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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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Change from Baseline SCIM III scale at 2 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Angel Gil-Agudo, PhD, MD, Head of Rehabilitation Department
Publications and helpful links
General Publications
- Colombo G, Joerg M, Schreier R, Dietz V. Treadmill training of paraplegic patients using a robotic orthosis. J Rehabil Res Dev. 2000 Nov-Dec;37(6):693-700.
- Zeilig G, Weingarden H, Zwecker M, Dudkiewicz I, Bloch A, Esquenazi A. Safety and tolerance of the ReWalk exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. J Spinal Cord Med. 2012 Mar;35(2):96-101. doi: 10.1179/2045772312Y.0000000003. Epub 2012 Feb 7.
- Kwakkel G, Kollen B, Lindeman E. Understanding the pattern of functional recovery after stroke: facts and theories. Restor Neurol Neurosci. 2004;22(3-5):281-99.
- Ditunno PL, Patrick M, Stineman M, Ditunno JF. Who wants to walk? Preferences for recovery after SCI: a longitudinal and cross-sectional study. Spinal Cord. 2008 Jul;46(7):500-6. doi: 10.1038/sj.sc.3102172. Epub 2008 Jan 22.
- Esquenazi A, Packel A. Robotic-assisted gait training and restoration. Am J Phys Med Rehabil. 2012 Nov;91(11 Suppl 3):S217-27; quiz S228-31. doi: 10.1097/PHM.0b013e31826bce18.
- Chen G, Patten C. Treadmill training with harness support: selection of parameters for individuals with poststroke hemiparesis. J Rehabil Res Dev. 2006 Jul-Aug;43(4):485-98. doi: 10.1682/jrrd.2005.04.0063.
- Mantone J. Getting a leg up? Rehab patients get an assist from devices such as HealthSouth's AutoAmbulator, but the robots' clinical benefits are still in doubt. Mod Healthc. 2006 Feb 13;36(7):58-60. No abstract available.
- Veneman JF, Kruidhof R, Hekman EE, Ekkelenkamp R, Van Asseldonk EH, van der Kooij H. Design and evaluation of the LOPES exoskeleton robot for interactive gait rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2007 Sep;15(3):379-86. doi: 10.1109/tnsre.2007.903919.
- Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabilitation robotics for walking training in neurological disorders: a review. J Rehabil Res Dev. 2011;48(4):387-416. doi: 10.1682/jrrd.2010.04.0055.
- Aach M, Cruciger O, Sczesny-Kaiser M, Hoffken O, Meindl RCh, Tegenthoff M, Schwenkreis P, Sankai Y, Schildhauer TA. Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord injury: a pilot study. Spine J. 2014 Dec 1;14(12):2847-53. doi: 10.1016/j.spinee.2014.03.042. Epub 2014 Apr 4.
- Jackson AB, Carnel CT, Ditunno JF, Read MS, Boninger ML, Schmeler MR, Williams SR, Donovan WH; Gait and Ambulation Subcommittee. Outcome measures for gait and ambulation in the spinal cord injury population. J Spinal Cord Med. 2008;31(5):487-99. doi: 10.1080/10790268.2008.11753644.
- Ditunno J, Scivoletto G. Clinical relevance of gait research applied to clinical trials in spinal cord injury. Brain Res Bull. 2009 Jan 15;78(1):35-42. doi: 10.1016/j.brainresbull.2008.09.003. Epub 2008 Oct 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI15/01437
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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