Powered Exoskeletons in Persons With SCI ((PEPSCI))

Study Description

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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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Detailed Description:

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 overground ambulation.

Research Questions (Objectives) Will Veterans with chronic SCI of six months duration, who are medically stable and who use a wheelchair as SOC plus an exoskeletal-assisted walking (EAW) device in their home and community environments have clinically meaningful net improvements in mental health, bladder, bowel, and pain patient-reported outcomes compared with those who use only the SOC? Additionally, will the use of an EAW device for four months in the homes and/or communities of the participants result in a reduction of total body fat mass? Study Design A two-group (Intervention and Control), randomized, clinical trial will be performed with a one-year feasibility component. The Intervention group will receive SOC plus EAW. The Control group will receive SOC only. The study will require six years in total to complete and includes ten VA SCI Services as study sites. A feasibility phase will be employed using a staggered start by initially starting six sites and the other four sites starting one year later. These initial six sites will be used to assess the start-up activities [hiring, training, equipment procurement, Central Institutional Review Board (CIRB) paperwork, etc.], the rate of recruitment, and any other issues that may be of value for the successful completion of the study. Lessons learned will be implemented for the remaining sites.

Relevance to VA In pilot studies conducted at the James J. Peters VA Medical Center, Bronx, NY, improvements in mental-emotional health, physical health and body composition were demonstrated by providing the participants the ability to walk for 4 to 6 hours per week over the course of three to five months. As of July 2014, a Class 2 designation was established by the Food and Drug Administration (FDA) for "powered exoskeletons". To date, one device (ReWalk ) has received FDA Class 2 approval for institutional and home use and is currently available by prescription. The Department of Veterans Affairs (DVA) is the largest single provider to persons with SCI in the USA, caring for about 26,000 of the 42,000 estimated Veterans with SCI. The VA presently lacks the infrastructure to support Veterans with SCI to train to use this device in order to make this technology available for the home/community use. A controlled research study would be anticipated to be the optimal manner to demonstrate the efficacy, amount of use and safety of a powered exoskeleton in the home and community environments; findings would be immediately transferable to clinical care.

Number of Research Participants (Sample Size) One hundred-sixty participants (80/group) will be randomized. Each of the 10 study sites will be expected to pre-screen 100 potential participants, screen 60 participants, and randomize 16 participants (8 per group) over the 2-year enrollment period.

Participating Sites Ten SCI Services will be selected on the basis of potential recruitment numbers (N=9,511 total Veterans with SCI in the sites' catchment areas and N=4,921 followed annually at these sites) and geographic location, to permit an even distribution across the country. The ten sites include: Boston, Richmond, St. Louis, Tampa, Milwaukee, Minneapolis, Dallas, Houston, Palo Alto, and Long Beach. Of these ten sites, five are VA Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES).

Duration of Participant Intake (Study Duration) The CS #2003 study duration is projected to be a total of six years: The initial six sites will have a start-up year, followed by participant enrollment/data collection during years 1 and 2, and continued data collection/closeout during year 3, for a total of four years. The remaining four sites will begin the start-up year one year after the first six sites and follow the same enrollment, data collection and closeout schedule over the next four years. The four sites are expected to be completed one year after the initial six sites have completed, and there is an additional year for the Coordinating Center and Chairperson's Office to complete data analysis and manuscript writing, thus the study total time is six years. Participants in both groups will be asked to commit 33 weeks to this study. Participants in the Control arm will be offered an additional 8 weeks to receive EAW training in the medical centers, without outcome data being collected.

Treatment (follow-up) The intervention being tested is four months of home and/or community use of a powered exoskeleton.

Definition of Participant Samples (Study Population) One-hundred sixty male or female Veterans / Active Duty military personnel with chronic SCI, six months duration, 21 years of age, functional use of their hands, medically stabile, and wheelchair users for indoor and outdoor mobility, will be eligible for screening. All potential participants will be Veterans / Active Duty military personnel with SCI. Study participants will generally be outpatients with the exception of those inpatients who meet the eligibility criteria, and who are approved by the Site Investigator (e.g., some inpatients may have been admitted for a wheelchair fitting or another non-medical reason). Non-veterans with SCI will not be.

Treatment Arms All participants will receive four months of treatment, randomized into two arms: SOC plus EAW or SOC only.

Endpoints Primary outcome one will be the Mental Component Summary of the Veterans Rand-36 (MCS/VR-36). Primary outcome two will be the sum T-score of the SCI-QOL bladder management difficulties, bowel management difficulties and pain interference item banks. The major secondary outcome will be total body fat mass. The two primary and the major secondary outcomes will be analyzed as the proportion of participants in each group who achieved a clinically meaningful change in score. The endpoint will be success or failure for these outcomes.

Study Design

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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
Estimated Primary Completion Date :	June 30, 2020
Estimated Study Completion Date :	August 31, 2020

Arms and Interventions

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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)

Outcome Measures

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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.

Eligibility Criteria

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Ages Eligible for Study:	21 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 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.

Contacts and Locations

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Contacts

Contact: Ann M Spungen, EdD	(718) 584-9000 ext 5814	Ann.Spungen@va.gov
Contact: William Bauman, MD	(718) 584-9000 ext 5428	william.bauman@va.gov

Locations

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 Alice.Hon3@va.gov
Contact: Maya Hatch 5628268000 ext 4541 Maya.Hatch@va.gov
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 Doug.Ota@va.gov
Contact: Ramya Gopalan 6504935000 ext 65090 Ramya.Gopalan@va.gov
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL	Recruiting
Tampa, Florida, United States, 33612
Contact: Kevin T White, MD 813-972-2000 Kevin.White2@va.gov
Contact: Brittany Durant 8139722000 ext 5466 Brittany.Durant@va.gov
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 Sunil.Sabharwal2@va.gov
Contact: Kandarp Mehta 8572036626 Kandarp.Mehta2@va.gov
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 stephanie.boyle@va.gov
Contact: Allison Wolf 6127252000 ext 1011 allison.wolfe@va.gov
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 Katherine.Stenson@va.gov
Contact: Stephanie Hedrick 3146524100 ext 64691 stephanie.hedrick@va.gov
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 bridget.bennett@va.gov
Contact: Lisa Jones 2148574897 Lisa.Jones@va.gov
Michael E. DeBakey VA Medical Center, Houston, TX	Recruiting
Houston, Texas, United States, 77030
Contact: Sally A Holmes, MD 713-794-7128 SallyA.Holmes@va.gov
Contact: Daisy Courtade 7137911414 ext 24233 Daisy.Courtade@va.gov
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 Lance.Goetz@va.gov
Contact: Jewel Moore 8046755000 ext 6741 Jewel.Moore@va.gov
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 denis.castillo@va.gov
Contact: Joseph Berman 4143842000 ext 42585 joseph.berman@va.gov

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Study Chair:	Ann M Spungen, EdD	VA Office of Research and Development

More Information

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Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT02658656 History of Changes
Other Study ID Numbers:	2003
First Posted:	January 20, 2016
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:

Exoskeleton

Additional relevant MeSH terms:

Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases	Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries