Status:
COMPLETED
Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
Lead Sponsor:
Ekso Bionics
Conditions:
Debility Due to Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A safety and feasibility study of robotic exoskeleton training in deconditioned patients residing in a healthcare facility.
Detailed Description
Patients who are hospitalized for several weeks or months are at a higher risk of decline in physical condition and are also at a higher risk of rehospitalization within 30 days of discharge. A progra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Pregnancy
- Any reason the physician may deem as harmful to the participant to enroll or continue in the study.
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03355755
Start Date
October 11 2017
End Date
December 13 2018
Last Update
April 14 2023
Active Locations (3)
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1
Gaylord Specialty Healthcare
Wallingford, Connecticut, United States, 06492
2
Marianjoy Rehabilitation Hospital
Wheaton, Illinois, United States, 60187
3
Quality Living, Inc
Omaha, Nebraska, United States, 68104