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

NCT03355755 | Completed Results FDA Device

• 1 other identifier: 107159
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Debility Due to Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experience an Adverse Event During Time of Treatment

  The primary endpoint is safety defined as the number of participants experiencing an adverse event per overall during the study period.

  2 weeks

Secondary Outcomes (1)

• Number of Participants Who Experience an Adverse Event During Time of Treatment That Was Deemed "Definitely Device Related"

  2 weeks

Study Arms (1)

Interventional Group

EXPERIMENTAL

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

Interventions

EksoGT with SmartAssist software DEVICE

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.

Interventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ekso Bionics: lead

Study Sites (3)

Gaylord Specialty Healthcare

Wallingford, Connecticut, 06492, United States

Location

Marianjoy Rehabilitation Hospital

Wheaton, Illinois, 60187, United States

Location

Quality Living, Inc

Omaha, Nebraska, 68104, United States

Location

Related Publications (5)

• Thomas JI, Lane JV. A pilot study to explore the predictive validity of 4 measures of falls risk in frail elderly patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1636-40. doi: 10.1016/j.apmr.2005.03.004.

  PMID: 16084819 BACKGROUND

• 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.

  PMID: 23810355 BACKGROUND

• 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.

  PMID: 24616216 BACKGROUND

• 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.

  PMID: 25133615 BACKGROUND

• 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.

  PMID: 26849277 BACKGROUND

Results Point of Contact

• Title: Leslie Van Hiel
• Organization: Ekso Bionics

leslie.vanhiel@gmail.com

4042268017

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm safety and feasibility study.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 28, 2017
• Study Start: October 11, 2017
• Primary Completion: December 13, 2018
• Study Completion: December 13, 2018
• Last Updated: April 14, 2023
• Results First Posted: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)