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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

Tracking Information
First Submitted Date  ICMJE November 3, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE October 11, 2017
Actual Primary Completion Date December 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
Official Title  ICMJE Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single-arm safety and feasibility study.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Debility Due to Disease
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: EksoGT with SmartAssist software
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2019)
22
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2017)
40
Actual Study Completion Date  ICMJE December 13, 2018
Actual Primary Completion Date December 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03355755
Other Study ID Numbers  ICMJE 107159
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ekso Bionics
Study Sponsor  ICMJE Ekso Bionics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ekso Bionics
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP