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Exoskeleton and Spinal Cord Injury (EXTra-SCI)

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ClinicalTrials.gov Identifier: NCT03410550
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ashraf Gorgey, McGuire Research Institute

Brief Summary:
The purpose of the current study is to investigate the effects of powered exoskeleton (EKSO) on cardiovascular performance as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments. The effects of exoskeleton training on walking kinematics including stand-up time, walking time, distance covered and speed of walking will also be evaluated.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Exoskeleton Training Phase 2

Detailed Description:

Powered exoskeletons using robotic suits have recently been introduced for the rehabilitation of persons with spinal cord injury (SCI). Exoskeletons offer a unique opportunity for persons with SCI to experience standing and walking at a low metabolic cost. Evidence suggested that exoskeleton assisted walking can decrease spasticity and improve bowel movement. Training may also improve the level of physical activity as well as psychological parameters that are likely to interfere with rehabilitation outcomes. Previous studies reported that a frequency of 2-3 times per week or more for 1-2 hours may be beneficial in the rehabilitation of persons with SCI. Using exoskeletal-assisted walking to improve the level of physical activity may be appealing to persons with SCI.

Exoskeleton training for 12 weeks may enhance energy expenditure, parameters of physical activity and result only on modest effects on both cardiovascular and body composition parameters. In other words, persons with tetraplegia may have greater cardiovascular and body composition adaptations compared to persons with paraplegia. Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exoskeleton Training After Spinal Cord Injury
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exoskeleton Training
Twenty men with complete and incomplete SCI will be enrolled in the trial.
Device: Exoskeleton Training
Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10).




Primary Outcome Measures :
  1. Blood Pressure (mmHg) [ Time Frame: 12 weeks ]
    Resting blood pressure and post-exercise blood pressure will be measured every visit.

  2. Walking time (minutes) [ Time Frame: 12 weeks ]
    The robotic unit will measure standing up time, walking time and walking distance for every visit.

  3. Oxygen uptake (l/min) [ Time Frame: 12 weeks ]
    Oxygen uptake will be measured during sitting, standing and walking at the beginning and at the end of the training program.

  4. Body Composition (kg) [ Time Frame: 12 weeks ]
    Body composition using dual energy x-ray absorptiometry anthropometrics' will be measured during sitting, standing and walking at the beginning and at the end of the training program.


Secondary Outcome Measures :
  1. Six minute-walk Test (meter) [ Time Frame: 12 weeks ]
    The test will competed at the beginning and at the end of study to measure distance.

  2. Walking Index for Spinal Cord Injury II (WISCI II) [ Time Frame: 12 weeks ]
    The test will competed at the beginning and at the end of study

  3. Electromyography (EMG) activity of 6 muscle groups (mV) [ Time Frame: 12 weeks ]
    The test will competed at the beginning and at the end of study

  4. Mitochondrial health using near infra-red spectroscopy (seconds) [ Time Frame: 12 weeks ]
    The test will competed at the beginning and at the end of study

  5. 10 meter walk Test (m/sec) [ Time Frame: 12 weeks ]
    The test will competed at the beginning and at the end of study to measure speed.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A written clearance by the medical doctor .
  2. Participants will have to be 1 year post-injury with any level of injury.
  3. All participants will be between 18-70 years old, men/women,

Exclusion Criteria:

  1. Participants with body weight greater than 220 lbs
  2. Whole body T-scores less than -2.5 standard deviation will result in elimination from the program.
  3. Hip width, upper leg length and lower leg length that do not fit in the robotic suit.
  4. Previous unhealed fracture in both lower or upper extremities
  5. Leg length discrepancy that is unlikely to be managed by having shoe inserts
  6. High resting blood pressure greater than 130/80 mmHg
  7. Sudden drop in blood pressure by 20 mmHg especially in persons with tetraplegia.
  8. Medical conditions prior enrollment similar to cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin, pressures sores stage 2 or greater, or urinary tract infection or symptoms.
  9. Pregnancy

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): NCT03410550


Locations
United States, Virginia
Hunter Holmes McGuire VA Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: Ashraf S Gorgey, PhD    804-675-5000 ext 3386    ashraf.gorgey@va.gov   
Contact: Timothy Lavis, MD    804-675-5000 ext 3391    timothy.lavis@va.gov   
Sub-Investigator: Lance Goetz, MD         
Sponsors and Collaborators
McGuire Research Institute

Responsible Party: Ashraf Gorgey, Director of SCI Research, McGuire Research Institute
ClinicalTrials.gov Identifier: NCT03410550     History of Changes
Other Study ID Numbers: 02375
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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