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Exoskeleton and Spinal Cord Injury (EXTra-SCI)

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ClinicalTrials.gov Identifier: NCT03410550
Recruitment Status : Not yet recruiting
First Posted : January 25, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ashraf Gorgey, McGuire Research Institute

January 11, 2018
January 25, 2018
March 29, 2018
May 1, 2018
December 30, 2019   (Final data collection date for primary outcome measure)
  • Blood Pressure (mmHg) [ Time Frame: 12 weeks ]
    Resting blood pressure and post-exercise blood pressure will be measured every visit.
  • Walking time (minutes) [ Time Frame: 12 weeks ]
    The robotic unit will measure standing up time, walking time and walking distance for every visit.
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT03410550 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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
  • EMG activity of 6 muscle groups (mV) [ Time Frame: 12 weeks ]
    The test will competed at the beginning and at the end of study
  • 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
  • 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.
Not Provided
Not Provided
 
Exoskeleton and Spinal Cord Injury
Exoskeleton Training After Spinal Cord Injury
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.

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.

Interventional
Phase 2
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
Spinal Cord Injuries
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).
Experimental: Exoskeleton Training
Twenty men with complete and incomplete SCI will be enrolled in the trial.
Intervention: Device: Exoskeleton Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
Same as current
December 30, 2019
December 30, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
United States
 
 
NCT03410550
02375
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
Plan to Share IPD: No
Ashraf Gorgey, McGuire Research Institute
McGuire Research Institute
Not Provided
Not Provided
McGuire Research Institute
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP