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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355755
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Ekso Bionics

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

Condition or disease Intervention/treatment Phase
Debility Due to Disease Device: EksoGT with SmartAssist software Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm safety and feasibility study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
Actual Study Start Date : October 11, 2017
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : December 13, 2018

Arm Intervention/treatment
Experimental: Interventional Group
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.
Device: EksoGT with SmartAssist software
Intervention will consist of exercise using the EksoGT exoskeleton for supported walking. The EksoGT is a powered motorized orthosis intended to enable individuals who are experiencing muscular or neurological conditions affecting their lower extremities to perform ambulatory functions such as gait training.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events [ Time Frame: 2 weeks ]
    The primary endpoint is safety defined as the number of device-related serious adverse events per Participant and overall during the study period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355755


Locations
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United States, Connecticut
Gaylord Specialty Healthcare
Wallingford, Connecticut, United States, 06492
United States, Illinois
Marianjoy Rehabilitation Hospital
Wheaton, Illinois, United States, 60187
United States, Nebraska
Quality Living, Inc
Omaha, Nebraska, United States, 68104
Sponsors and Collaborators
Ekso Bionics
Publications:
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Responsible Party: Ekso Bionics
ClinicalTrials.gov Identifier: NCT03355755    
Other Study ID Numbers: 107159
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No