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Powered Assist Hip Exoskeleton to Improve Ambulation in Severe Lung Disease

Sponsor
West Park Healthcare Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05835271
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
11.3
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: exoskeleton assist
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Exoskeleton Assist to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease
Anticipated Study Start Date :
Apr 21, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. walking endurance time [an average of 7 tests over 4 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Westpark Health Care Centre Toronto Ontario Canada M6M 2J5

Sponsors and Collaborators

  • West Park Healthcare Centre

Investigators

  • Principal Investigator: Roger Goldstein, West Park Healthcare Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Roger Goldstein, Director, Program in Respiratory Rehabilitation, West Park Healthcare Centre
ClinicalTrials.gov Identifier:
NCT05835271
Other Study ID Numbers:
  • XO-Nof1-RCT-RG2023
First Posted:
Apr 28, 2023
Last Update Posted:
Apr 28, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Roger Goldstein, Director, Program in Respiratory Rehabilitation, West Park Healthcare Centre
Walking
Exoskeleton Device
Additional relevant MeSH terms:
Lung Diseases

Study Results

No Results Posted as of Apr 28, 2023