Powered Exoskeletons in Persons With SCI ((PEPSCI))

• 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: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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

Detailed Description:

Administrative hold due to COVID-19 pandemic.

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 seven years in total to complete and includes fifteen VA SCI Services as study sites. A feasibility phase will be employed using a staggered start by initially starting six sites, four sites starting one year later, and 5 other sites starting two years 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 15 study sites will be expected to pre-screen 100 potential participants, screen 60 participants, to reach the target of 160 randomized over 15 sites.

Participating Sites Fifteen SCI Services will be selected on the basis of potential recruitment numbers (N=13,606 total Veterans with SCI in the sites' catchment areas and N=7,022 followed annually at these sites) and geographic location, to permit an even distribution across the country. The fifteen sites include: Boston, Richmond, St. Louis, Tampa, Milwaukee, Minneapolis, Dallas, Houston, Palo Alto, Long Beach, Augusta, San Antonio, Bronx, Cleveland, and Albuquerque. Of these fifteen 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 seven years: The initial six sites will have a start-up year, followed by participant enrollment/data collection during years 1-4, and continued data collection/closeout during year 5, for a total of six years. The next 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 five years. The next five sites will begin start-up one year after the four sites and follow the same enrollment, data collection and closeout schedule. All fifteen sites will be closed out after six years, 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 seven 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 or military members with chronic SCI, six months duration, 18 years of age, functional use of their hands, medically stable, and wheelchair users for indoor and outdoor mobility, will be eligible for screening. All potential participants will be Veterans or military members 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 eligible.

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

• 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

Arms and Interventions

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)

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• 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:

Study Protocol and Statistical Analysis Plan  [PDF] July 12, 2021

More Information

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

• 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:

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