Powered Assist to Improve Ambulation in Severe Lung Disease

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.

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Key information

Conditions

Lung Disease Chronic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westpark Health Care Centre

Toronto, Ontario, M6M 2J5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exoskeleton assist

Device

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 outcomes

walking endurance time

Time frame: an average of 7 tests over 4 weeks

tolerance (time) of an individualized constant, brisk, walking speed endurance test

Sponsors and collaborators

Lead sponsor

West Park Healthcare Centre

Other

Registry information

Official study title

Assistive Device to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease - Evaluated Using a Single-Case Series Experimental Design

Acronym: REVIVE

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2021
First posted: Dec 31, 2018
Registry last updated: May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed