This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    NCT02658656
Previous Study | Return to List | Next Study

CSP #2003 - Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life ((PEPSCI))

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02658656
First received: January 6, 2016
Last updated: April 14, 2017
Last verified: April 2017
  Purpose
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 Intervention
Spinal Cord Injury Device: ReWalk 6.0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: CSP #2003 - Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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: 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.


Estimated Enrollment: 160
Actual Study Start Date: August 1, 2016
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02658656

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, New York
James J. Peters VA Medical Center, Bronx, NY Active, not recruiting
Bronx, New York, United States, 10468
United States, Texas
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   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Study Chair: Ann M Spungen, EdD VA Office of Research and Development
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02658656     History of Changes
Other Study ID Numbers: 2003
Study First Received: January 6, 2016
Last Updated: April 14, 2017
Individual Participant Data  
Plan to Share IPD: 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

ClinicalTrials.gov processed this record on June 23, 2017