Powered Exoskeletons in Persons With SCI ((PEPSCI))
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02658656 |
Recruitment Status :
Completed
First Posted : January 20, 2016
Last Update Posted : October 22, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injury | Device: ReWalk 6.0 | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 161 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 |
Actual Study Completion Date : | September 30, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Exoskeleton + SOC
Patient will receive exoskeletal-assisted walking device for in home use for 4 months
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Device: ReWalk 6.0
Exoskeletal Assisted Walking Device |
No Intervention: SOC
Patient will receive standard of care (wheelchair use)
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- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Veterans or active duty military personnel who are at least 18 years of age;
- Traumatic or non-traumatic SCI 6 months duration of SCI;
- Wheelchair-user for indoor and outdoor mobility;
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Anthropometric compatibility with the device:
- Weight <220 lb. (100 kg),
- Thigh length between 14 and 19 in (36 and 48 cm),
- Shank length between 17 and 22 in (43 and 55 cm);
- Able to hold the crutches in hands without modifications;
- 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
- Able to provide informed consent.
Exclusion Criteria:
- Diagnosis of neurological injury other than SCI;
- Progressive condition that would be expected to result in changing neurological status;
- Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
- 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;
- Knee BMD < 0.60 gm/cm2;
- Total hip BMD T-scores < -3.5;
- Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury (definition below);
- Untreatable severe spasticity judged to be contraindicated by the Site Physician;
- Flexion contracture > 15� at the hip and/or > 10� at the knee;
- Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion > 00);
- Untreated or uncontrolled hypertension (systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg);
- Unresolved orthostatic hypotension (systolic blood pressure <90 mmHg; diastolic blood pressure <60 mmHg) as judged to be contraindicated by the Site Physician;
- Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
- Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
- Pregnancy or women who plan to become pregnant during the study period.

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
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 |
Study Chair: | Ann M Spungen, EdD | James J. Peters Veterans Affairs Medical Center |
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: | October 22, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Individual Participant Data will not be shared. |
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 |
Exoskeleton |
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |