Lung Disease Chronic Clinical Trial
Official title:
Exoskeleton Assist to Improve Physical Performance in Patients With Very Severe Chronic Respiratory 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 hip 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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | March 30, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Westpark Health Care Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
West Park Healthcare Centre |
Canada,
Dolmage TE, Goldstein RS. Assisting Walking in Patients with Chronic Respiratory Disease Using a Powered Exoskeleton: A Series of N-of-1 Clinical Trials. Ann Am Thorac Soc. 2022 Jul;19(7):1230-1232. doi: 10.1513/AnnalsATS.202201-045RL. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | walking endurance time | tolerance (time) of an individualized constant, brisk, walking speed endurance test | an average of 7 tests over 4 weeks |
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