Debility Due to DiseaseNCT03355755
Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
A study testing EksoGT with SmartAssist software in people with Debility Due to Disease, run by Ekso Bionics at 3 sites in United States.
Trial summary
A safety and feasibility study of robotic exoskeleton training in deconditioned patients residing in a healthcare facility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Debility Due to Disease
- What is being tested?
- EksoGT with SmartAssist software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Oct 2017to 13 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Quality Living, Inc
Omaha, Nebraska, 68104
Gaylord Specialty Healthcare
Wallingford, Connecticut, 06492
Marianjoy Rehabilitation Hospital
Wheaton, Illinois, 60187
About this study
A safety and feasibility study of robotic exoskeleton training in deconditioned patients residing in a healthcare facility.
Read the 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.
- Conditions
- Debility Due to Disease
- Being tested
- EksoGT with SmartAssist software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EksoGT with SmartAssist softwareDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EksoGT with SmartAssist software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (1)
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start11 Oct 2017
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Debility Due to DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm safety and feasibility study.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ekso Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355755
- Sponsor's protocol ID
- 107159
- Status last verified
- Apr 2023
- First submitted
- 3 Nov 2017
- Last updated
- 14 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16084819Hoyer 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.
PubMed 23810355Hoyer 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.
PubMed 24616216Hoyer 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.
PubMed 25133615Hoyer 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.
PubMed 26849277
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exoskeleton Treatment of Deconditioning Due to Limited Ambulation Caused by Illness or Injury
- ClinicalTrials.gov ID
- NCT03355755
- Acronym / sponsor ID
- 107159
- Conditions
- Debility Due to Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ekso BionicsIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Posted 14 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm safety and feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Device: EksoGT with SmartAssist softwareAll participants will be included in the interventional group. Intervention will consist of walking exercise using the EksoGT exoskeleton for supported walking, running SmartAssist software. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (27 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EksoGT with SmartAssist softwareIntervention 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. | Device | Interventional Group |
Primary outcome
Number of Participants Who Experience an Adverse Event During Time of Treatment
Time frame: 2 weeks
The primary endpoint is safety defined as the number of participants experiencing an adverse event per overall during the study period.
1 secondary outcome
Number of Participants Who Experience an Adverse Event During Time of Treatment That Was Deemed "Definitely Device Related"
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16084819Thomas 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.
- Background: PubMed 23810355Hoyer 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.
- Background: PubMed 24616216Hoyer 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.
- Background: PubMed 25133615Hoyer 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.
- Background: PubMed 26849277Hoyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EksoGT with SmartAssist software in people with Debility Due to Disease, run by Ekso Bionics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience an Adverse Event During Time of Treatment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03355755, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.