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

NCT03477123 | Completed DMC

• 1 other identifier: PI15/01437
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Incomplete Spinal Cord Injury

Keywords

Incomplete spinal cord injury; Walking; Rehabilitation; Robotic exoskeleton

Outcome Measures

Primary Outcomes (7)

• 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.

  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).

  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.

  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.

  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.

  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.

  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.

  Through study completion

Secondary Outcomes (1)

• Spinal Cord Independence Measure III (SCIM III)

  Change from Baseline SCIM III scale at 2 months

Study Arms (2)

Intervention

EXPERIMENTAL

Walking therapy with Exo-H2 exoskeleton

Device: Walking therapy with Exo-H2 exoskeleton

Control

NO INTERVENTION

Group receiving conventional walking therapy without robotic exoskeleton

Interventions

Walking therapy with Exo-H2 exoskeleton DEVICE

Intervention

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Nacional de Parapléjicos de Toledo: lead
• Institut Guttmann: collaborator

Study Sites (1)

National Hospital for Paraplegics

Toledo, 45071, Spain

Location

Related Publications (12)

• 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.

  PMID: 18209742 BACKGROUND

• 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.

  PMID: 23080038 BACKGROUND

• 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.

  PMID: 15502272 BACKGROUND

• 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.

  PMID: 17123188 BACKGROUND

• 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.

  PMID: 11321005 BACKGROUND

• 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.

  PMID: 16515076 BACKGROUND

• 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.

  PMID: 17894270 BACKGROUND

• 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.

  PMID: 21674390 BACKGROUND

• 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.

  PMID: 22333043 BACKGROUND

• 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.

  PMID: 24704677 BACKGROUND

• 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.

  PMID: 19086706 BACKGROUND

• 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.

  PMID: 18848865 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Angel Gil-Agudo, PhD, MD

  Head of Rehabilitation Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator does not have information on the group the patient was enrolled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, Head of Rehabilitation

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 26, 2018
• Study Start: January 1, 2016
• Primary Completion: March 31, 2020
• Study Completion: July 3, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)