Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease

Lung Disease Chronic Clinical Trial

Official title:

Exoskeleton Assist to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835271
• Other study ID #: XO-Nof1-RCT-RG2023
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2024
• Source: West Park Healthcare Centre
• Contact: Tom Dolmage
• Phone: 4162433600
• Email: tom.dolmage[@]westpark.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lung Disease Chronic
• Lung Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Westpark Health Care Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
West Park Healthcare Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

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