Clinical trial NCT03790644: Powered Assist to Improve Ambulation in Severe Lung Disease
Official title: Assistive Device to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease - Evaluated Using a Single-Case Series Experimental Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Disease Chronic
Keywords: Walking
Exoskeleton Device
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


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
* a high risk of fracture

Primary outcomes:
measure: walking endurance time
timeFrame: an average of 7 tests over 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Westpark Health Care Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Roger S Goldstein
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.