NCT02658656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
424

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 6, 2022

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

4.7 years

First QC Date

January 6, 2016

Results QC Date

March 30, 2022

Last Update Submit

October 23, 2024

Conditions

Spinal Cord Injury

Keywords

Exoskeleton

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (27)

  • Total Body Fat Loss in All Randomized Participants

    4 months post intervention

  • Improvement on the Mental Health Component Summary (MCS) in Participants Who Completed the 4 Month Intervention Phase.

    4 months post intervention

  • Improvement on the SCI-QOL Physical Medical Health Domain in Participants Who Completed the 4 Month Intervention Phase.

    4 months post intervention

  • Total Body Fat Loss in Participants Who Completed the 4 Month Intervention Phase.

    4 months post intervention

  • Change in Mental Health Component Summary (MCS)

    post training/orientation, two months post intervention, and 4 months post intervention.

  • +22 more secondary outcomes

Study Arms (2)

Exoskeleton + Standard of Care (SOC)

ACTIVE COMPARATOR

Patient will receive exoskeletal-assisted walking device for in home use for 4 months

Device: ReWalk 6.0

Standard of Care (SOC)

NO INTERVENTION

Patient will receive standard of care (wheelchair use)

Interventions

ReWalk 6.0DEVICE

Exoskeletal Assisted Walking Device

Exoskeleton + Standard of Care (SOC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Charlie Norwood VA Medical Center, Augusta, GA

Augusta, Georgia, 30904, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, 63106, United States

Location

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-1000, United States

Location

Related Publications (1)

  • 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.

    PMID: 39230903RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Dr. Ann Spungen, Study Chairperson
Organization
James J Peters VA Medical Center
ann.spungen@va.gov
7185849000

Study Officials

  • Ann M Spungen, EdD

    James J. Peters Veterans Affairs Medical Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 20, 2016

Study Start

August 1, 2016

Primary Completion

March 31, 2021

Study Completion

September 30, 2021

Last Updated

November 4, 2024

Results First Posted

June 6, 2022

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Individual Participant Data will not be shared.

Locations

US(15)