Inspiratory and Trunk Muscle Activity During IMT on Stable and Unstable Surfaces in Stroke Patients

March 11, 2025 updated by: LIU FANG, Hong Kong Metropolitan University

Inspiratory and Trunk Muscle Activity During Inspiratory Muscle Training on Stable and Unstable Surfaces in People After Stroke

This study aims to investigate the differences in muscle recruitment of the diaphragm (assessed using ultrasound), the sternocleidomastoid (SCM) and trunk muscles (both measured via surface electromyography (sEMG)), during loaded breathing training performed on both stable and unstable surfaces. The goal is to understand the interaction between the inspiratory and trunk muscles during Inspiratory muscle training (IMT) across these two surface conditions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

24

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

People diagnosed with stroke who meet the criteria will be invited to participate in the study

Description

Inclusion Criteria:

  • Age ≥ 40 years and < 80 years
  • Breathing spontaneously
  • Clinically diagnosed with ischemic and/or hemorrhagic stroke
  • Stroke duration from onset between 1 and 12 months
  • No thoracic or abdominal surgery in the past 6 months
  • No cognitive impairment (Montreal Cognitive Assessment (MoCA) score ≥ 26)
  • Able to understand and follow verbal instructions
  • No facial palsy or only mild facial palsy without limitation of labial occlusion
  • Able to complete all loaded breathing tests on both stable and unstable surfaces included in this study

Exclusion Criteria:

  • Acute myocardial infarction or acute heart failure
  • Acute pain in any part of the body
  • History of chronic respiratory illness or positive clinical signs of impaired respiratory function (such as shortness of breath, hypoxemia, chronic cough, and sputum retention)
  • Presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragmatic thickening fraction
Time Frame: Day 1
Diaphragmatic thickening fraction is determined by "(thickness of the diaphragm at end inspiratory - thickness at end expiratory)/thickness at end expiratory". Diaphragmatic thickness will be measured by ultrasonography.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle activation of the sternocleidomastoid muscle
Time Frame: Day 1
Surface electromyography (sEMG) will be used to measure accessory inspiratory muscle (sternocleidomastoid muscles) activity during all breathing protocol tests.
Day 1
Muscle activation of the trunk muscles
Time Frame: Day 1
Surface electromyography (sEMG) will be used to measure the muscle activity of rectus abdominis (RA), external oblique (EO), internal oblique/transversus abdominis (IO/TrA), and erector spinae (ES)- using sEMG during all breathing protocol tests.
Day 1
Perceived Exertion Borg scale
Time Frame: Day 1
This is a vertical scale quantified from 0 to 10, where 0 represents no symptoms, and 10 represents the maximum symptoms. The Borg score provides an individual measurement of the exercise intensity.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Metropolitan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

August 15, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No: HE-OT2023/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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