Powered Exoskeletons in Persons With SCI ((PEPSCI))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02658656
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : June 8, 2018
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently become available as an alternate form of mobility by providing an external framework for support and computer controlled motorized hip and knee joints to assist with over ground ambulation.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: ReWalk 6.0 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CSP #2003 - Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Exoskeleton + SOC
Patient will receive exoskeletal-assisted walking device for in home use for 4 months
Device: ReWalk 6.0
Exoskeletal Assisted Walking Device

No Intervention: SOC
Patient will receive standard of care (wheelchair use)

Primary Outcome Measures :
  1. Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) [ Time Frame: Change from Baseline Assessment to 4 Months Post Intervention ]
    The Veterans RAND 36 Item Health Survey (VR-36) is a brief, generic, multi-use, self-administered health survey comprised of 36 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. The outcome in this study is the score from the Mental Health Component Summary (MCS) of the VR-36, which measures the vitality, social functioning, role-emotional, and mental health of the participant.

  2. The sum T-score for the SCI-QOL Physical Medical Health domain (three item banks of Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference) [ Time Frame: Baseline, Post Observation/Training phase, post 2 month Intervention, post 4 month Intervention ]
    The Primary Objectives are to demonstrate that Veterans with chronic SCI of =six months duration who are medically stable and are wheelchair users for indoor and outdoor mobility as their standard of care (SOC) plus use of an exoskeletal-assisted walking device in their home and community environments will have clinically meaningful net improvements in the MCS/VR-36 and in patient-reported outcomes for the SCI-QOL bladder, bowel, and pain item banks compared with those who use only SOC for home and community mobility. The primary outcomes to be assessed will be the MCS value and the sum T-score of the SCI-QOL bladder management difficulties, bowel management difficulties and pain interference item banks.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Veterans or active duty military personnel who are at least 21 years of age;
  2. Traumatic or non-traumatic SCI greater than or equal to 6 months duration of SCI;
  3. Wheelchair-user for indoor and outdoor mobility;
  4. Level and completeness of injury as follows:

    1. SCI levels between cervical six (C6) and thoracic three (T3) with an upper extremity motor function in each muscle group of 4 or greater;
    2. T4 and below with complete or incomplete SCI (ISNCSCI A to D);
  5. Anthropometric compatibility with the device:

    1. Weight <220 lb. (100 kg),
    2. Thigh length between 14 and 19 in (36 and 48 cm),
    3. Shank length between 17 and 22 in (43 and 55 cm);
  6. Able to hold the crutches in hands, with or without minor assistive modifications;
  7. Able to have a companion who can attend approximately one-third of the training sessions who will assist them at home and in the community; and
  8. Able to provide informed consent.

Exclusion Criteria:

  1. Diagnosis of neurological injury other than SCI;
  2. Progressive condition that would be expected to result in changing neurological status;
  3. Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
  4. Traumatic or high impact lower extremity fracture within the past 2 years;
  5. Knee BMD < 0.60 gm/cm2;
  6. Total hip BMD T-scores < -3.5;
  7. Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury;
  8. Untreatable severe spasticity judged to be contraindicated by the Site Physician;
  9. Flexion contracture limited to > 0 at the hip and/or > 10 at the knee;
  10. Limitations in ankle range of motion that cannot be adapted with a orthotic device;
  11. Chronic anticoagulation therapy;
  12. Able to ambulate 10 meters in 60 seconds (approximately 0.17 m/s) with or without a non-exoskeletal assistive device or physical assistance.
  13. Untreated or uncontrolled hypertension (systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg);
  14. Unresolved orthostatic hypotension (systolic blood pressure <90 mmHg; diastolic blood pressure <60 mmHg) as judged to be contraindicated by the Site Physician;
  15. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
  16. Psychopathology documentation in the medical record or history of that may conflict with study objectives; and/or
  17. Pregnancy or women who plan to become pregnant during the study period.

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 identifier (NCT number): NCT02658656

Contact: Ann M Spungen, EdD (718) 584-9000 ext 5814
Contact: William Bauman, MD (718) 584-9000 ext 5428

United States, California
VA Long Beach Healthcare System, Long Beach, CA Recruiting
Long Beach, California, United States, 90822
Contact: Alice J Hon, MD    609-314-5582   
Contact: Maya Hatch    5628268000 ext 4541   
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Doug Ota, MD    650-493-5000 ext 64007   
Contact: Ramya Gopalan    6504935000 ext 65090   
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL Recruiting
Tampa, Florida, United States, 33612
Contact: Kevin T White, MD    813-972-2000   
Contact: Brittany Durant    8139722000 ext 5466   
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Sunil Sabharwal, MD    617-323-7700 ext 36574   
Contact: Kandarp Mehta    8572036626   
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Stephanie Boyle, MD    612-725-2000 ext 7625   
Contact: Allison Wolf    6127252000 ext 1011   
United States, Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO Recruiting
Saint Louis, Missouri, United States, 63106
Contact: Katherine Stenson, MD    314-652-4100 ext 64831   
Contact: Stephanie Hedrick    3146524100 ext 64691   
United States, New York
James J. Peters VA Medical Center, Bronx, NY Active, not recruiting
Bronx, New York, United States, 10468
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Recruiting
Dallas, Texas, United States, 75216
Contact: Bridget Bennett, MD    214-857-4515   
Contact: Lisa Jones    2148574897   
Michael E. DeBakey VA Medical Center, Houston, TX Recruiting
Houston, Texas, United States, 77030
Contact: Sally A Holmes, MD    713-794-7128   
Contact: Daisy Courtade    7137911414 ext 24233   
United States, Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA Recruiting
Richmond, Virginia, United States, 23249
Contact: Lance L Goetz, MD    804-675-5000 ext 2475   
Contact: Jewel Moore    8046755000 ext 6741   
United States, Wisconsin
Clement J. Zablocki VA Medical Center, Milwaukee, WI Recruiting
Milwaukee, Wisconsin, United States, 53295-1000
Contact: Castillo Denis, MD    414-384-2000 ext 42585   
Contact: Joseph Berman    4143842000 ext 42585   
Sponsors and Collaborators
VA Office of Research and Development
Study Chair: Ann M Spungen, EdD James J. Peters Veterans Affairs Medical Center

Responsible Party: VA Office of Research and Development Identifier: NCT02658656     History of Changes
Other Study ID Numbers: 2003
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 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

Keywords provided by VA Office of Research and Development:

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