Powered Assist to Improve Ambulation in Severe Lung Disease

NCT03790644 | Completed

• 1 other identifier: XO-Nof1-RCT-RG2019
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disease Chronic

Keywords

Walking; Exoskeleton Device

Outcome Measures

Primary Outcomes (1)

• walking endurance time

  tolerance (time) of an individualized constant, brisk, walking speed endurance test

  an average of 7 tests over 4 weeks

Study Arms (1)

exoskeleton assist

EXPERIMENTAL

walking with assist of a powered exoskeleton

Device: exoskeleton assist

Interventions

exoskeleton assist DEVICE

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.

exoskeleton assist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable chronic respiratory disease
• modified medical research council dyspnoea score (mMRC) ≥ 2

You may not qualify if:

• 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

Sponsors & Collaborators

• West Park Healthcare Centre: lead

Study Sites (1)

Westpark Health Care Centre

Toronto, Ontario, M6M 2J5, Canada

Location

Related 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.

  PMID: 35348445 RESULT

Study Officials

• Roger S Goldstein

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Program in Respiratory Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 31, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: May 30, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)