Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: exoskeleton assist.
- Who it may be relevant to
- Registry conditions: Lung Disease Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exoskeleton Assist to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease
Overview
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.
Interventions
- Device exoskeleton assist
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.
Primary outcome measures
- walking endurance time [Time frame: an average of 7 tests over 4 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Westpark Health Care Centre — Toronto
Publications
- 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. PMID 35348445
Identifiers
NCT: NCT05835271 · XO-Nof1-RCT-RG2023