Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease

West Park Healthcare Centre

Status: Invitation-only

Conditions: Lung Disease Chronic

Treatments: Device: exoskeleton assist

Study type: Interventional

Funder types: Other

Identifiers

NCT05835271

XO-Nof1-RCT-RG2023

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

exoskeleton assist

Experimental group

Description:

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 belt frame, sensors that detect a user's desired movements, a computerized controller, motors and actuators, and lightweight batteries.

Treatment:

Device: exoskeleton assist