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Powered Exoskeletons in Persons With SCI ((PEPSCI))

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ClinicalTrials.gov Identifier: NCT02658656
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : April 22, 2021
Sponsor:
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

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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
Actual Primary Completion Date : March 31, 2021
Estimated Study Completion Date : September 30, 2021

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: Change from Baseline Assessment to 4 Months Post Intervention ]
    The Spinal Cord Injury - Quality of Life (SCI-QOL) measurement tool was developed to assess patient reported outcome measures in persons with SCI. It is comprised of four broad domains of physical-medical health, emotional health, social participation, and physical functioning. Primary Outcome #2 will be a sum of the scores on the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks within the Physical-Medical Health domain.


Secondary Outcome Measures :
  1. Total Body Fat Mass (Kg) [ Time Frame: Change from Baseline Assessment to 4 Months Post Intervention ]
    Total body fat mass as measured by DXA (Dual energy X-Absorptiometry) scan.



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

Inclusion Criteria:

  1. Veterans or active duty military personnel who are at least 18 years of age;
  2. Traumatic or non-traumatic SCI 6 months duration of SCI;
  3. Wheelchair-user for indoor and outdoor mobility;
  4. 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);
  5. Able to hold the crutches in hands without modifications;
  6. 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
  7. 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. Unhealed or unstable traumatic or high impact lower extremity fracture (definition below) of any duration that is in the clinical judgement of the study physician to be exclusionary for standing and walking;
  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 (definition below);
  8. Untreatable severe spasticity judged to be contraindicated by the Site Physician;
  9. Flexion contracture > 15� at the hip and/or > 10� at the knee;
  10. Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion > 00);
  11. Untreated or uncontrolled hypertension (systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg);
  12. Unresolved orthostatic hypotension (systolic blood pressure <90 mmHg; diastolic blood pressure <60 mmHg) as judged to be contraindicated by the Site Physician;
  13. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
  14. Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
  15. 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 ClinicalTrials.gov identifier (NCT number): NCT02658656


Locations
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United States, California
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
United States, Georgia
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, United States, 30904
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
Saint Louis, Missouri, United States, 63106
United States, New Mexico
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States, 87108-5153
United States, New York
James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, United States, 10468
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States, 78229
United States, Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249
United States, Wisconsin
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Study Chair: Ann M Spungen, EdD James J. Peters Veterans Affairs Medical Center
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02658656    
Other Study ID Numbers: 2003
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Exoskeleton
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries