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Clinical Trials/NCT03790644
NCT03790644
Completed
Not Applicable

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

West Park Healthcare Centre1 site in 1 country6 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Disease Chronic
Sponsor
West Park Healthcare Centre
Enrollment
6
Locations
1
Primary Endpoint
walking endurance time
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
May 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roger Goldstein

Director, Program in Respiratory Rehabilitation

West Park Healthcare Centre

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

Outcomes

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

Study Sites (1)

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