Powered Assist to Improve Ambulation in Severe Lung Disease

Not Applicable

Completed

• Conditions: Lung Disease Chronic
• Interventions: Device: exoskeleton assist

• Registration Number: NCT03790644
• Lead Sponsor: West Park Healthcare Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2018-12-31
• Primary Completion: 2019-12-31
• Study Completion: 2021-05-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
exoskeleton assist	exoskeleton assist	walking with assist of a powered exoskeleton

Primary Outcome Measures

Name	Time	Method
walking endurance time	an average of 7 tests over 4 weeks	tolerance (time) of an individualized constant, brisk, walking speed endurance test

Trial Locations

Locations (1)

Westpark Health Care Centre; 🇨🇦 Toronto, Ontario, Canada