Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury

Completed · Not applicable

Conditions studied: Debility Due to Disease

In brief

A safety and feasibility study of robotic exoskeleton training in deconditioned patients residing in a healthcare facility.

Key facts

Study ID

NCT03355755

Run by

Ekso Bionics

People needed

15

Starts

2017-10-11

Expected to finish

2018-12-13

Last updated by the study team

2023-04-14

Who can join

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

You may qualify if…

• A diagnosis of "deconditioned", defined as the loss of muscle tone and endurance due to chronic disease, immobility, or loss of function.
• Adults 18 years and older (or as specified by state law).
• Admitted into a hospital, long-term care facility, skilled nursing facility, or similar.
• Sufficient upper extremity strength to use a front wheeled walker by manual muscle testing (minimum triceps strength bilaterally of 3/5, shoulder abduction and flexion/extension 4/5).
• Screened and cleared by a physician for full weight-bearing exercise training.
• Weigh 220 pounds (100kg) or less.
• Between approximately 5'0" and 6'4" tall.
• Standing hip width of approximately 18" or less.
• Have near normal range of motion in hips, knees and ankles.

You may not qualify if…

• Currently involved in another intervention study.
• Transferred to the intensive care unit or isolation-room stay.
• Currently on a ventilator or extracorporeal membrane oxygenation (ECMO) machine.
• Currently have a ventricular assist device (VAD) or an automatic implantable cardioverter-defibrillator (AICD).
• Advanced heart failure - ejection fraction of < 20%.
• Documented cardiovascular risk from exercise.
• Resting heart rate <50 bpm or >120 bpm.
• Uncontrolled or new (within 24 hours) arrythmias.
• Resting blood pressure below 90/70 or above 160/100.
• Oxygen saturation (O2 sat) < 90% during rest.
• Uncontrolled or severe orthostatic hypotension that limits standing tolerance.
• Cardiac ischemia within 24 hours.
• Unresolved or new (within 24 hours) deep vein thrombosis.
• Concurrent severe neurological pathology/disease or stroke within 72 hours.
• Open skin ulcerations on any body surfaces in contact with exoskeleton.
• Acute fracture
• Osteoporosis
• Active heterotrophic ossification (HO) of the lower extremity, hip dysplasia, or hip/knee axis abnormalities.
• Current chemotherapy
• Inability to speak or understand the English language.
• Inability to cooperate in tests/exercises.
• Hip flexion contracture greater than \~17°.
• Knee flexion contracture greater than 12°.
• Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion).
• Cognitive impairments - unable to follow 2 step commands or to communicate pain or to stop session.

Where it is running

• Gaylord Specialty Healthcare — Wallingford, Connecticut, United States
• Marianjoy Rehabilitation Hospital — Wheaton, Illinois, United States
• Quality Living, Inc — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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