Clinical trial NCT02658656: Powered Exoskeletons in Persons With SCI
Official title: CSP #2003 - Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Exoskeleton
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-01-20
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Improvement on the MCS in All Randomized Participants
timeFrame: Change from Baseline Assessment to 4 Months Post Intervention
measure: Improvement on the SCI-QOL Physical Medical Health Domain in All Randomized Participants
timeFrame: Change from Baseline Assessment to 4 Months Post Intervention
Secondary outcomes:
measure: Total Body Fat Loss in All Randomized Participants
timeFrame: 4 months post intervention
measure: Improvement on the Mental Health Component Summary (MCS) in Participants Who Completed the 4 Month Intervention Phase.
timeFrame: 4 months post intervention
measure: Improvement on the SCI-QOL Physical Medical Health Domain in Participants Who Completed the 4 Month Intervention Phase.
timeFrame: 4 months post intervention
measure: Total Body Fat Loss in Participants Who Completed the 4 Month Intervention Phase.
timeFrame: 4 months post intervention
measure: Change in Mental Health Component Summary (MCS)
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in SCI-QOL Physical Medical Health Domain
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in Total Body Fat
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in SCI-QOL Social Participation Domain
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in SCI-QOL Positive Emotional Constraints
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in SCI-QOL Negative Emotional Constraints
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in SCI Functional Index (FI)
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in Sleep Disturbance
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in Participant Impression of Severity
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in Companion Impression of Severity
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Bowel Evacuation Time
timeFrame: 4 months post intervention
measure: Frequency of Bowel Evacuation Episodes
timeFrame: 4 months post intervention
measure: Manual/Digit Stimulation for Bowel Movements
timeFrame: 4 months post intervention
measure: Oral Medications for Bowel Movements
timeFrame: 4 months post intervention
measure: Enemas or Irrigations for Bowel Movements
timeFrame: 4 months post intervention
measure: Bowel Control
timeFrame: 4 months post intervention
measure: Stool Consistency
timeFrame: 4 months post intervention
measure: Change in Abdominal Fat Mass
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in High Density Lipoprotein Cholesterol
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in Low Density Lipoprotein Cholesterol
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in Total Cholesterol
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in Triglycerides
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
measure: Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: post training/orientation, two months post intervention, and 4 months post intervention.
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System, Long Beach, CA
state: California
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Augusta
country: United States
facility: Charlie Norwood VA Medical Center, Augusta, GA
state: Georgia
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis VA Medical Center John Cochran Division, St. Louis, MO
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque, NM
state: New Mexico
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
city: Milwaukee
country: United States
facility: Clement J. Zablocki VA Medical Center, Milwaukee, WI
state: Wisconsin
Study officials:
affiliation: James J. Peters Veterans Affairs Medical Center
name: Ann M Spungen, EdD
role: STUDY_CHAIR
References:
citation: Spungen AM, Dematt EJ, Biswas K, Jones KM, Mi Z, Snodgrass AJ, Morin K, Asselin PK, Cirnigliaro CM, Kirshblum S, Gorman PH, Goetz LL, Stenson K, White KT, Hon A, Sabharwal S, Kiratli BJ, Ota D, Bennett B, Berman JE, Castillo D, Lee KK, Eddy BW, Henzel MK, Trbovich M, Holmes SA, Skelton F, Priebe M, Kornfeld SL, Huang GD, Bauman WA. Exoskeletal-Assisted Walking in Veterans With Paralysis: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2431501. doi: 10.1001/jamanetworkopen.2024.31501.