We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658656
Recruitment Status : Completed
First Posted : January 20, 2016
Results First Posted : June 6, 2022
Last Update Posted : October 27, 2022
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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exoskeleton + Standard of Care (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: Standard of Care (SOC)
Patient will receive standard of care (wheelchair use)



Primary Outcome Measures :
  1. Improvement on the MCS in All Randomized Participants [ Time Frame: Change from Baseline Assessment to 4 Months Post Intervention ]
    Number of randomized participants with a greater than or equal to 4 point change on the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from Baseline Assessment to 4 Months Post Intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.

  2. Improvement on the SCI-QOL Physical Medical Health Domain in All Randomized Participants [ Time Frame: Change from Baseline Assessment to 4 Months Post Intervention ]
    Number of randomized participants with a greater than or equal to 10 percent decrease on the SCI-QOL Physical Medical Health Domain (PMH) from Baseline Assessment to 4 Months Post Intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.


Secondary Outcome Measures :
  1. Total Body Fat Loss in All Randomized Participants [ Time Frame: 4 months post intervention ]
    Number of randomized participants with a greater than or equal to 1kg of total body fat loss from Baseline Assessment to 4 Months Post Intervention

  2. Improvement on the Mental Health Component Summary (MCS) in Participants Who Completed the 4 Month Intervention Phase. [ Time Frame: 4 months post intervention ]
    Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 4 point increase on the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from Baseline Assessment to 4 Months Post Intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.

  3. Improvement on the SCI-QOL Physical Medical Health Domain in Participants Who Completed the 4 Month Intervention Phase. [ Time Frame: 4 months post intervention ]
    Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 10 percent improvement (decrease) on the Spinal Cord Injury Quality of Life (SCI-QOL) Physical Medical Health Domain (PMH) from Baseline Assessment to 4 Months Post Intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.

  4. Total Body Fat Loss in Participants Who Completed the 4 Month Intervention Phase. [ Time Frame: 4 months post intervention ]
    Number of participants, out of those who completed the 4 month intervention phase, with a greater than or equal to 1kg of total body fat loss from Baseline Assessment to 4 Months Post Intervention

  5. Change in Mental Health Component Summary (MCS) [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Mean difference score in the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.

  6. Change in SCI-QOL Physical Medical Health Domain [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Mean difference score in the SCI-QOL Physical Medical Health Domain from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.

  7. Change in Total Body Fat [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Change in total body fat from baseline to post training/orientation, two months post intervention, and 4 months post intervention

  8. Change in SCI-QOL Social Participation Domain [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Mean difference score in the SCI-QOL Social Health Domain from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Social Health Domain score is a sum of the SCI-QOL scores from the ability to participate in social roles and activities, satisfaction with social roles and activities, and independence item banks. Possible range of the Social Health Domain score is 78 to 191, with a higher score indicating higher social health.

  9. Change in SCI-QOL Positive Emotional Constraints [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Mean difference score in the SCI-QOL Positive Emotional Constraints from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Positive Emotional Constraints score is a sum of the SCI-QOL scores from the positive affect and well being, self-esteem, and resilience item banks. Possible range of the Positive Emotional Constraints score is 63 to 199, with a higher score indicating better emotional wellbeing.

  10. Change in SCI-QOL Negative Emotional Constraints [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Mean difference score in the SCI-QOL Negative Emotional Constraints from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The Negative Emotional Constraints score is a sum of the SCI-QOL scores from the anxiety, depression, grief-loss, trauma, and stigma item banks. Possible range of the Negative Emotional Constraints score is 182 to 405, with a lower score indicating better emotional wellbeing.

  11. Change in SCI Functional Index (FI) [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Mean difference score in the SCI Functional Index (FI) from baseline to post training/orientation, two months post intervention, and 4 months post intervention. The SCI Function Index for physical function is a sum of the basic mobility, ambulation, fine motor, self-care, and wheelchair mobility item banks. Possible range of the SCI Functional Index is 188 to 408, with a higher score indicating better physical function.

  12. Change in Sleep Disturbance [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Mean difference T-score of the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the PROMIS is 28.9 to 76.5, with a higher score indicating more sleep disturbance.

  13. Change in Participant Impression of Severity [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Mean difference in the participant impression of severity of spinal cord injury from the Global Impression of Change Scale from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the participant impression of severity is 1 to 7, with a higher score indicating worse impression of severity of spinal cord injury.

  14. Change in Companion Impression of Severity [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Mean difference in the companion impression of severity of spinal cord injury from the Global Impression of Change Scale from baseline to post training/orientation, two months post intervention, and 4 months post intervention. Possible range of the companion impression of severity is 1 to 7, with a higher score indicating worse impression of severity of spinal cord injury.

  15. Bowel Evacuation Time [ Time Frame: 4 months post intervention ]
    Time spent to have a bowel movement per bowel day, over 7 days. Responses were collected using a 5-point likert scale with the following options: 5 to 15 minutes; 15 to 30 minutes; 30 to 60 minutes; 1 to 3 hours; more than 3 hours.

  16. Frequency of Bowel Evacuation Episodes [ Time Frame: 4 months post intervention ]
    Frequency of bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: 7 times or more; 5 to 6 times; 3 to 4 times; 1 to 2 times; none.

  17. Manual/Digit Stimulation for Bowel Movements [ Time Frame: 4 months post intervention ]
    Needed manual/digit stimulation for bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.

  18. Oral Medications for Bowel Movements [ Time Frame: 4 months post intervention ]
    Required oral medications to help with bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.

  19. Enemas or Irrigations for Bowel Movements [ Time Frame: 4 months post intervention ]
    Required enemas or irrigations to help with bowel movements over 7 days. Responses were collected using a 5-point Likert scale with the following options: none/never; only once; a few times; most times; every time.

  20. Bowel Control [ Time Frame: 4 months post intervention ]
    Bowel accidents over 7 days. Responses were collected using a 5-point Likert scale with the following options: no leakage or accidents; leakage or an accident 1-2 times; leakage or an accident 3-4 times; leakage or an accident 5-6 times; leakage or an accident 7 or more times.

  21. Stool Consistency [ Time Frame: 4 months post intervention ]
    Stool consistency by the Bristol Stool Scale over 7 days. The Bristol Stool Scale classifies stools into seven groups: separate hard lumps; sausage-shaped, but lumpy; like sausage, cracks on surface; like a snake, smooth and soft; soft blobs (passed easily); fluffy pieces, a mush stool; watery, entirely liquid.

  22. Change in Abdominal Fat Mass [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Change in visceral adipose tissue mass measured from bone density scan, in grams, from baseline to post training/orientation, two months post intervention, and 4 months post intervention

  23. Change in High Density Lipoprotein Cholesterol [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Change in high density lipoprotein cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention

  24. Change in Low Density Lipoprotein Cholesterol [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Change in low density lipoprotein cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention

  25. Change in Total Cholesterol [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Change in total cholesterol, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention

  26. Change in Triglycerides [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Change in triglycerides, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention

  27. Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [ Time Frame: post training/orientation, two months post intervention, and 4 months post intervention. ]
    Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to post training/orientation, two months post intervention, and 4 months post intervention. HOMA-IR= Fasting insulin (mIU/ml) x Fasting glucose (mg/dl) / 405.



Information from the National Library of Medicine

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.


Layout table for eligibility information
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 degrees at the hip and/or > 10 degrees 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
Layout table for location information
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
Layout table for investigator information
Study Chair: Ann M Spungen, EdD James J. Peters Veterans Affairs Medical Center
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Layout table for additonal information
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
Results First Posted: June 6, 2022
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be shared.

Layout table for additional information
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:
Layout table for MeSH terms
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries