Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Disease Chronic
• Intervention / Treatment: Device: exoskeleton assist

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tom Dolmage; Phone Number: 2185 4162433600; Email: tom.dolmage@westpark.org

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6M 2J5
      • Recruiting
      • Westpark Health Care Centre
      • Principal Investigator: Roger Goldstein, MD, FRCPC
      • Sub-Investigator: Tom Dolmage, MSc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
walking endurance time	tolerance (time) of an individualized constant, brisk, walking speed endurance test	an average of 7 tests over 4 weeks

Collaborators and Investigators

• Sponsor: West Park Healthcare Centre
• Investigators: Principal Investigator: Roger Goldstein, West Park Healthcare Centre

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Walking; Exoskeleton Device
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: XO-Nof1-RCT-RG2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No