- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06877338
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.
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.