Powered Exoskeletons in Persons With SCI

Completed · Not applicable

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT02658656

Run by

VA Office of Research and Development

People needed

424

Starts

2016-08-01

Expected to finish

2021-09-30

Last updated by the study team

2024-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• 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.

Where it is running

• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States
• Charlie Norwood VA Medical Center, Augusta, GA — Augusta, Georgia, United States
• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri, United States
• New Mexico VA Health Care System, Albuquerque, NM — Albuquerque, New Mexico, United States
• James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
• South Texas Health Care System, San Antonio, TX — San Antonio, Texas, United States
• Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia, United States
• Clement J. Zablocki VA Medical Center, Milwaukee, WI — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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