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

Not Applicable

Completed

• Conditions: Debility Due to Disease
• Interventions: Device: EksoGT with SmartAssist software

• Registration Number: NCT03355755
• Lead Sponsor: Ekso Bionics

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.

Study Timeline

• Study Start: 2017-10-11
• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-28
• Primary Completion: 2018-12-13
• Study Completion: 2018-12-13
• Results First Submitted: 2023-02-17
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-13
• Last Update Submitted: 2023-04-13
• Results First Posted: 2023-04-14
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Group	EksoGT with SmartAssist software	All participants will be included in the interventional group. Intervention will consist of walking exercise using the EksoGT exoskeleton for supported walking, running SmartAssist software.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event During Time of Treatment	2 weeks	The primary endpoint is safety defined as the number of participants experiencing an adverse event per overall during the study period.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event During Time of Treatment That Was Deemed "Definitely Device Related"	2 weeks	Count of number of participants who experienced any adverse event that was rated as definitely related to treatment with the Ekso device.

Trial Locations

Locations (3)

Quality Living, Inc; 🇺🇸 Omaha, Nebraska, United States

Marianjoy Rehabilitation Hospital; 🇺🇸 Wheaton, Illinois, United States

Gaylord Specialty Healthcare; 🇺🇸 Wallingford, Connecticut, United States