Powered Assist to Improve Ambulation in Severe Lung Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Disease Chronic

Intervention / Treatment
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* Device: exoskeleton assist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exoskeleton assist<br>walking with assist of a powered exoskeleton | Device: exoskeleton assist<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| walking endurance time | tolerance (time) of an individualized constant, brisk, walking speed endurance test | an average of 7 tests over 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking, Exoskeleton Device