Powered Exoskeletons in Persons With SCI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CSP #2003 - Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: ReWalk 6.0


Participation Criteria
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Eligibility Criteria
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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; 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 degrees at the hip and/or > 10 degrees 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exoskeleton + Standard of Care (SOC)<br>Patient will receive exoskeletal-assisted walking device for in home use for 4 months | Device: ReWalk 6.0<br>* Exoskeletal Assisted Walking Device<br>|
| No Intervention: Standard of Care (SOC)<br>Patient will receive standard of care (wheelchair use) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement on the MCS in All Randomized Participants | 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. | Change from Baseline Assessment to 4 Months Post Intervention | 
| Improvement on the SCI-QOL Physical Medical Health Domain in All Randomized Participants | 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. | Change from Baseline Assessment to 4 Months Post Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Body Fat Loss in All Randomized Participants | 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 | 4 months post intervention | 
| Improvement on the Mental Health Component Summary (MCS) in Participants Who Completed the 4 Month Intervention Phase. | 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. | 4 months post intervention | 
| Improvement on the SCI-QOL Physical Medical Health Domain in Participants Who Completed the 4 Month Intervention Phase. | 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 months post intervention | 
| Total Body Fat Loss in Participants Who Completed the 4 Month Intervention Phase. | 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 | 4 months post intervention | 
| Change in Mental Health Component Summary (MCS) | 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. | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in SCI-QOL Physical Medical Health Domain | 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. | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in Total Body Fat | Change in total body fat from baseline to post training/orientation, two months post intervention, and 4 months post intervention | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in SCI-QOL Social Participation Domain | 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. | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in SCI-QOL Positive Emotional Constraints | 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. | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in SCI-QOL Negative Emotional Constraints | 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. | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in SCI Functional Index (FI) | 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. | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in Sleep Disturbance | 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. | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in Participant Impression of Severity | 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. | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in Companion Impression of Severity | 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. | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Bowel Evacuation Time | 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. | 4 months post intervention | 
| Frequency of Bowel Evacuation Episodes | 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. | 4 months post intervention | 
| Manual/Digit Stimulation for Bowel Movements | 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. | 4 months post intervention | 
| Oral Medications for Bowel Movements | 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. | 4 months post intervention | 
| Enemas or Irrigations for Bowel Movements | 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. | 4 months post intervention | 
| Bowel Control | 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. | 4 months post intervention | 
| Stool Consistency | 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. | 4 months post intervention | 
| Change in Abdominal Fat Mass | 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 | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in High Density Lipoprotein Cholesterol | 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 | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in Low Density Lipoprotein Cholesterol | 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 | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in Total Cholesterol | 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 | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in Triglycerides | Change in triglycerides, in milligrams per deciliter (mg/dL), from baseline to post training/orientation, two months post intervention, and 4 months post intervention | post training/orientation, two months post intervention, and 4 months post intervention. | 
| Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | 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. | post training/orientation, two months post intervention, and 4 months post intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exoskeleton