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Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease

Primary Purpose

Lung Disease Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
exoskeleton assist
Sponsored by
West Park Healthcare Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Disease Chronic focused on measuring Walking, Exoskeleton Device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Westpark Health Care CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exoskeleton assist

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 17, 2023
Last Updated
August 22, 2023
Sponsor
West Park Healthcare Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05835271
Brief Title
Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease
Official Title
Exoskeleton Assist to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Park Healthcare Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease Chronic
Keywords
Walking, Exoskeleton Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exoskeleton assist
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
exoskeleton assist
Intervention 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 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 Measure Information:
Title
walking endurance time
Description
tolerance (time) of an individualized constant, brisk, walking speed endurance test
Time Frame
an average of 7 tests over 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Dolmage
Phone
4162433600
Ext
2185
Email
tom.dolmage@westpark.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Goldstein
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westpark Health Care Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Goldstein, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Tom Dolmage, MSc.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35348445
Citation
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.
Results Reference
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Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease

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