Lung Disease ChronicREVIVENCT03790644
Powered Assist to Improve Ambulation in Severe Lung Disease
A study testing exoskeleton assist in people with Lung Disease Chronic, run by West Park Healthcare Centre at 1 site in Canada.
Trial summary
Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide with disabling consequences. Many with a compromised respiratory system cannot support the metabolic energy demands of walking causing them to walk slowly and stop often. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Disease Chronic
- What is being tested?
- exoskeleton assist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2018to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- stable chronic respiratory disease
- modified medical research council dyspnoea score (mMRC) ≥ 2
Who cannot join
- evidence of cardiac rhythm or circulatory compromise
- myocardial infarct within the previous three months
- moderate-severe aortic stenosis
- uncontrolled hypertension
- sustained cardiac arrhythmias
- untreated neoplasia
Show all 11Show fewer
- lung surgery within the previous three months
- any other predominant co-morbidities or treatments that might influence walk testing
- body size outside of exoskeleton fit specifications
- skin sores or skin breakdown in the area where the device is worn
- a high risk of fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assistive Device to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease - Evaluated Using a Single-Case Series Experimental Design
Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide with disabling consequences. Many with a compromised respiratory system cannot support the metabolic energy demands of walking causing them to walk slowly and stop often. Those with CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes part of the energy of walking. Assisting the legs will lower the metabolic energy demands, and therefore the ventilation required for exercise, thereby allowing them to walk faster and further. Proposed is a series of single-case experiments comparing walking endurance with and without a powered exoskeleton assist. The aim of this study is to determine the efficacy of an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton could be a novel immediate and long term strategy to augment walking as part of the spectrum of pulmonary rehabilitation and community reintegration.
- Conditions
- Lung Disease Chronic
- Being tested
- exoskeleton assist
- Keywords
- Walking, Exoskeleton Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exoskeleton assistDevice
A powered exoskeleton describes a wearable robot designed around the shape and function of the human body with segments and joints externally coupled to those of the user. The exoskeleton includes a rigid outer frame, sensors that detect a user's desired movements, a computerized controller, motors and actuators, and lightweight batteries.
The exoskeleton is designed to be worn in the community.
| Study group | Role | What they receive |
|---|---|---|
| exoskeleton assist | Experimental | walking with assist of a powered exoskeleton Receives: Device: exoskeleton assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking endurance time
tolerance (time) of an individualized constant, brisk, walking speed endurance test
Measured: an average of 7 tests over 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2019
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Disease ChronicStudies 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
- A prospective longitudinal, self-controlled, single-case repeated measures alternating treatment, randomized and counterbalanced cross-over experimental trial design, comparing walking endurance without and with a powered exoskeleton.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
- Investigators
- Roger S Goldstein, Principal investigator, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790644
- Sponsor's protocol ID
- XO-Nof1-RCT-RG2019
- Acronym
- REVIVE
- Status last verified
- Apr 2022
- First submitted
- 20 Dec 2018
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be available to other researchers.
Publications
Dolmage TE, Goldstein RS. Assisting Walking in Patients with Chronic Respiratory Disease Using a Powered Exoskeleton: A Series of N-of-1 Clinical Trials. Ann Am Thorac Soc. 2022 Jul;19(7):1230-1232. doi: 10.1513/AnnalsATS.202201-045RL. No abstract available.
PubMed 35348445
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistive Device to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease - Evaluated Using a Single-Case Series Experimental Design
- ClinicalTrials.gov ID
- NCT03790644
- Acronym / sponsor ID
- REVIVE / XO-Nof1-RCT-RG2019
- Conditions
- Lung Disease Chronic
- Keywords
- Walking, Exoskeleton Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide with disabling consequences. Many with a compromised respiratory system cannot support the metabolic energy demands of walking causing them to walk slowly and stop often. Those with CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes part of the energy of walking. Assisting the legs will lower the metabolic energy demands, and therefore the ventilation required for exercise, thereby allowing them to walk faster and further. Proposed is a series of single-case experiments comparing walking endurance with and without a powered exoskeleton assist. The aim of this study is to determine the efficacy of an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton could be a novel immediate and long term strategy to augment walking as part of the spectrum of pulmonary rehabilitation and community reintegration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective longitudinal, self-controlled, single-case repeated measures alternating treatment, randomized and counterbalanced cross-over experimental trial design, comparing walking endurance without and with a powered exoskeleton.
| Arm | Type | Receives |
|---|---|---|
| exoskeleton assist | Experimental | Device: exoskeleton assistwalking with assist of a powered exoskeleton |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable chronic respiratory disease
- modified medical research council dyspnoea score (mMRC) ≥ 2
Key exclusion criteria (11 listed)
- evidence of cardiac rhythm or circulatory compromise
- myocardial infarct within the previous three months
- moderate-severe aortic stenosis
- uncontrolled hypertension
- sustained cardiac arrhythmias
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 |
|---|---|---|
| exoskeleton assistA powered exoskeleton describes a wearable robot designed around the shape and function of the human body with segments and joints externally coupled to those of the user. The exoskeleton includes a rigid outer frame, sensors that detect a user's desired movements, a computerized controller, motors and actuators, and lightweight batteries. The exoskeleton is designed to be worn in the community. | Device | exoskeleton assist |
Primary outcome
walking endurance time
Time frame: an average of 7 tests over 4 weeks
tolerance (time) of an individualized constant, brisk, walking speed endurance test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Results publication: PubMed 35348445Dolmage TE, Goldstein RS. Assisting Walking in Patients with Chronic Respiratory Disease Using a Powered Exoskeleton: A Series of N-of-1 Clinical Trials. Ann Am Thorac Soc. 2022 Jul;19(7):1230-1232. doi: 10.1513/AnnalsATS.202201-045RL. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be available to other researchers.
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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.
Roger S Goldstein principal investigator
West Park Healthcare Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exoskeleton assist in people with Lung Disease Chronic, run by West Park Healthcare Centre at 1 site in Canada.
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 2 inclusion and 11 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 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
walking endurance time (time frame: an average of 7 tests over 4 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 NCT03790644, which also lists 1 linked publication.
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 4 May 2022.