Powered Assist to Improve Ambulation in Severe Lung Disease (REVIVE)
Primary Purpose
Lung Disease Chronic
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
exoskeleton assist
Sponsored by
About this trial
This is an interventional treatment trial for Lung Disease Chronic focused on measuring Walking, Exoskeleton Device
Eligibility Criteria
Inclusion Criteria:
- stable chronic respiratory disease
- modified medical research council dyspnoea score (mMRC) ≥ 2
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Westpark Health Care Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exoskeleton assist
Arm Description
walking with assist of a powered exoskeleton
Outcomes
Primary Outcome Measures
walking endurance time
tolerance (time) of an individualized constant, brisk, walking speed endurance test
Secondary Outcome Measures
Full Information
NCT ID
NCT03790644
First Posted
December 20, 2018
Last Updated
April 27, 2022
Sponsor
West Park Healthcare Centre
1. Study Identification
Unique Protocol Identification Number
NCT03790644
Brief Title
Powered Assist to Improve Ambulation in Severe Lung Disease
Acronym
REVIVE
Official Title
Assistive Device to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease - Evaluated Using a Single-Case Series Experimental Design
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Park Healthcare Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease Chronic
Keywords
Walking, Exoskeleton Device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exoskeleton assist
Arm Type
Experimental
Arm Description
walking with assist of a powered exoskeleton
Intervention Type
Device
Intervention Name(s)
exoskeleton assist
Intervention Description
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.
Primary Outcome Measure Information:
Title
walking endurance time
Description
tolerance (time) of an individualized constant, brisk, walking speed endurance test
Time Frame
an average of 7 tests over 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable chronic respiratory disease
modified medical research council dyspnoea score (mMRC) ≥ 2
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger S Goldstein
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westpark Health Care Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be available to other researchers.
Citations:
PubMed Identifier
35348445
Citation
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.
Results Reference
result
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Powered Assist to Improve Ambulation in Severe Lung Disease
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