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Powered Hip Exoskeleton for Severe Lung Disease

N/A

Recruiting

Led By Roger Goldstein

Research Sponsored by West Park Healthcare Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Modified medical research council dyspnoea score (mMRC) ≥ 2

Be older than 18 years old

Must not have

Skin sores or skin breakdown in the area where the device is worn

Sustained cardiac arrhythmias

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an average of 7 tests over 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if using a powered hip exoskeleton device can help people with chronic respiratory disease walk longer and faster.

Who is the study for?

This trial is for people with stable chronic respiratory disease who experience moderate to severe difficulty breathing during activity. They must fit within the size specifications of the exoskeleton and not have skin issues, heart problems, recent lung surgery or myocardial infarction, untreated cancer, or a high risk of fractures.

What is being tested?

The study tests if a powered hip exoskeleton can help patients with severe lung disease walk faster and longer by reducing the energy needed for walking. Participants will compare their walking endurance with and without this assistive device in single-case experiments.

What are the potential side effects?

Potential side effects may include discomfort or skin irritation where the exoskeleton attaches, muscle strain from using the device, and possible exacerbation of existing health conditions due to increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I often feel short of breath when moving around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have skin sores where the device will be placed.

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I have ongoing irregular heartbeats.

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My high blood pressure is not under control.

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I am at high risk for breaking bones.

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I have not had lung surgery in the last 3 months.

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I have a tumor that has not been treated.

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I have a serious narrowing of my heart's aortic valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ an average of 7 tests over 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~an average of 7 tests over 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 7 tests over 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

walking endurance time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: exoskeleton assistExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

exoskeleton assist

2018

N/A

~10

0 / 8Eligibility criteria met