Powered Assist to Improve Ambulation in Severe Lung Disease (REVIVE)

April 27, 2022 updated by: Roger Goldstein, West Park Healthcare Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6M 2J5
        • Westpark Health Care Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Device: exoskeleton assist

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

This is where you will find people and organizations involved with this study.

Sponsor

West Park Healthcare Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 28, 2018

First Posted (Actual)

December 31, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

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)?

NO

IPD Plan Description

Individual participant data (IPD) will not be available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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