Clinical trial NCT03355755: Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
Official title: Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Debility Due to Disease
Lead sponsor: Ekso Bionics
Sponsor class: INDUSTRY
First posted: 2017-11-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm safety and feasibility study.
Primary purpose: TREATMENT

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 program incorporating robotic exoskeleton training may provide sufficient physical support and challenge for patients to maintain a higher level of physical condition than if they did not undergo exoskeleton training. The investigators aim to demonstrate that EksoGT robotic exoskeleton training can be performed safely with patients who have been hospitalized and are at risk of experiencing a further decline in their physical condition.

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of "deconditioned", defined as the loss of muscle tone and endurance due to chronic disease, immobility, or loss of function.
2. Adults 18 years and older (or as specified by state law).
3. Admitted into a hospital, long-term care facility, skilled nursing facility, or similar.
4. 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).
5. Screened and cleared by a physician for full weight-bearing exercise training.
6. Weigh 220 pounds (100kg) or less.
7. Between approximately 5'0" and 6'4" tall.
8. Standing hip width of approximately 18" or less.
9. Have near normal range of motion in hips, knees and ankles.

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event During Time of Treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event During Time of Treatment That Was Deemed "Definitely Device Related"
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Wallingford
country: United States
facility: Gaylord Specialty Healthcare
state: Connecticut
city: Wheaton
country: United States
facility: Marianjoy Rehabilitation Hospital
state: Illinois
city: Omaha
country: United States
facility: Quality Living, Inc
state: Nebraska
Study officials:
References:
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citation: Hoyer EH, Needham DM, Miller J, Deutschendorf A, Friedman M, Brotman DJ. Functional status impairment is associated with unplanned readmissions. Arch Phys Med Rehabil. 2013 Oct;94(10):1951-8. doi: 10.1016/j.apmr.2013.05.028. Epub 2013 Jun 26.
citation: Hoyer EH, Needham DM, Atanelov L, Knox B, Friedman M, Brotman DJ. Association of impaired functional status at hospital discharge and subsequent rehospitalization. J Hosp Med. 2014 May;9(5):277-82. doi: 10.1002/jhm.2152. Epub 2014 Feb 26.
citation: Hoyer EH, Brotman DJ, Chan KS, Needham DM. Barriers to early mobility of hospitalized general medicine patients: survey development and results. Am J Phys Med Rehabil. 2015 Apr;94(4):304-12. doi: 10.1097/PHM.0000000000000185.
citation: Hoyer EH, Friedman M, Lavezza A, Wagner-Kosmakos K, Lewis-Cherry R, Skolnik JL, Byers SP, Atanelov L, Colantuoni E, Brotman DJ, Needham DM. Promoting mobility and reducing length of stay in hospitalized general medicine patients: A quality-improvement project. J Hosp Med. 2016 May;11(5):341-7. doi: 10.1002/jhm.2546. Epub 2016 Feb 5.