StrokeNCT06877338
Inspiratory and Trunk Muscle Activity During IMT on Stable and Unstable Surfaces in Stroke Patients
An observational study of Stroke and Inspiratory Muscle Training, run by Hong Kong Metropolitan University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Inspiratory Muscle Training, Diaphragm
- What is being tested?
- Loaded breathing on stable and unstable surfaces
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 15 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Adult, Older adult
Study population: People diagnosed with stroke who meet the criteria will be invited to participate in the study
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Stroke, Inspiratory Muscle Training, Diaphragm, Sternocleidomastoid Muscles, Trunk Muscle Activity
- Being tested
- Loaded breathing on stable and unstable surfaces
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loaded breathing on stable and unstable surfacesOther
Participants will be instructed to perform 10 loaded breaths via a threshold inspiratory load device on both a stable surface (sitting on a chair, Protocol 1) and an unstable surface (sitting on a soft pad, Protocol 2) in random order. The inspiratory load/resistance will be set at 50% of the maximum inspiratory pressure (MIP).
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic thickening fraction
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.
Measured: Day 1
Secondary outcomes (3)
Muscle activation of the sternocleidomastoid muscle
Surface electromyography (sEMG) will be used to measure accessory inspiratory muscle (sternocleidomastoid muscles) activity during all breathing protocol tests.
Measured: Day 1
Muscle activation of the trunk muscles
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.
Measured: Day 1
Perceived Exertion Borg scale
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIU FANG, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877338
- Sponsor's protocol ID
- No: HE-OT2023/13
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu F, Jones AYM, Tsang RCC, Yam TTT, Tsang WWN. Effect of unstable surface during loaded-inspiratory task on diaphragm and trunk muscle activity in stroke patients. Eur J Appl Physiol. 2026 Apr 10. doi: 10.1007/s00421-026-06198-6. Online ahead of print.
PubMed 41961279
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory and Trunk Muscle Activity During Inspiratory Muscle Training on Stable and Unstable Surfaces in People After Stroke
- ClinicalTrials.gov ID
- NCT06877338
- Acronym / sponsor ID
- No: HE-OT2023/13
- Conditions
- Stroke, Inspiratory Muscle Training, Diaphragm, Sternocleidomastoid Muscles, Trunk Muscle Activity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People diagnosed with stroke who meet the criteria will be invited to participate in the study
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loaded breathing on stable and unstable surfacesParticipants will be instructed to perform 10 loaded breaths via a threshold inspiratory load device on both a stable surface (sitting on a chair, Protocol 1) and an unstable surface (sitting on a soft pad, Protocol 2) in random order. The inspiratory load/resistance will be set at 50% of the maximum inspiratory pressure (MIP). | Other | – |
Primary outcome
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.
3 secondary outcomes
Muscle activation of the sternocleidomastoid muscle
Time frame: Day 1
Muscle activation of the trunk muscles
Time frame: Day 1
Perceived Exertion Borg scale
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Derived from this study: PubMed 41961279Liu F, Jones AYM, Tsang RCC, Yam TTT, Tsang WWN. Effect of unstable surface during loaded-inspiratory task on diaphragm and trunk muscle activity in stroke patients. Eur J Appl Physiol. 2026 Apr 10. doi: 10.1007/s00421-026-06198-6. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Inspiratory Muscle Training, run by Hong Kong Metropolitan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic thickening fraction (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06877338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.