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

Primary Purpose

Debility Due to Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EksoGT with SmartAssist software

About this trial

This is an interventional treatment trial for Debility Due to Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Acute fracture
Osteoporosis
Active heterotrophic ossification (HO) of the lower extremity, hip dysplasia, or hip/knee axis abnormalities.
Current chemotherapy
Inability to speak or understand the English language.
Inability to cooperate in tests/exercises.
Hip flexion contracture greater than ~17°.
Knee flexion contracture greater than 12°.
Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion).
Cognitive impairments - unable to follow 2 step commands or to communicate pain or to stop session.
Pregnancy
Any reason the physician may deem as harmful to the participant to enroll or continue in the study.

Sites / Locations

Gaylord Specialty Healthcare
Marianjoy Rehabilitation Hospital
Quality Living, Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Count of number of participants who experienced any adverse event that was rated as definitely related to treatment with the Ekso device.

Full Information

NCT ID

NCT03355755

First Posted

November 3, 2017

Last Updated

April 13, 2023

Sponsor

Ekso Bionics

1. Study Identification

Unique Protocol Identification Number

NCT03355755

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

October 11, 2017 (Actual)

Primary Completion Date

December 13, 2018 (Actual)

Study Completion Date

December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ekso Bionics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Debility Due to Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single-arm safety and feasibility study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interventional Group

Arm Type

Experimental

Arm Description

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 Type

Device

Intervention Name(s)

EksoGT with SmartAssist software

Intervention Description

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 Measure Information:

Title

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

Description

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

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

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

Description

Count of number of participants who experienced any adverse event that was rated as definitely related to treatment with the Ekso device.

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Acute fracture Osteoporosis Active heterotrophic ossification (HO) of the lower extremity, hip dysplasia, or hip/knee axis abnormalities. Current chemotherapy Inability to speak or understand the English language. Inability to cooperate in tests/exercises. Hip flexion contracture greater than ~17°. Knee flexion contracture greater than 12°. Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion). Cognitive impairments - unable to follow 2 step commands or to communicate pain or to stop session. Pregnancy Any reason the physician may deem as harmful to the participant to enroll or continue in the study.

Facility Information:

Facility Name

Gaylord Specialty Healthcare

City

Wallingford

State/Province

Connecticut

ZIP/Postal Code

06492

Country

United States

Facility Name

Marianjoy Rehabilitation Hospital

City

Wheaton

State/Province

Illinois

ZIP/Postal Code

60187

Country

United States

Facility Name

Quality Living, Inc

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16084819

Citation

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.

Results Reference

background

PubMed Identifier

23810355

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.

Results Reference

background

PubMed Identifier

24616216

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.

Results Reference

background

PubMed Identifier

25133615

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.

Results Reference

background

PubMed Identifier

26849277

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.

Results Reference

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

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