- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790644
Powered Assist to Improve Ambulation in Severe Lung Disease (REVIVE)
Assistive Device to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease - Evaluated Using a Single-Case Series Experimental Design
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6M 2J5
- Westpark Health Care Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exoskeleton assist
walking with assist of a powered exoskeleton
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
walking endurance time
Time Frame: an average of 7 tests over 4 weeks
|
tolerance (time) of an individualized constant, brisk, walking speed endurance test
|
an average of 7 tests over 4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XO-Nof1-RCT-RG2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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