StrokeNCT06640101
Effects of Inspiratory Muscle Training on Stroke Rehabilitation Outcomes
A study testing IMT-stable group (sitting on a stable surface), IMT-unstable group (sitting on an unstable surface) and Conventional treatment in people with Stroke, run by Hong Kong Metropolitan University at 1 site in China.
Trial summary
This study is designed to explore the effects of a 4-week protocol of inspiratory muscle training (IMT) at 50% maximum inspiratory pressure (MIP) on respiratory function, diaphragm thickness, balance control, exercise capacity, and quality of life in people after stroke. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- IMT-stable group (sitting on a stable surface), IMT-unstable group (sitting on an unstable surface) and Conventional treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2025to 15 Jun 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years and < 80 years;
- breathing spontaneously;
- clinically diagnosed with ischemic and/or haemorrhagic stroke;
- duration of stroke from onset falls within 1 month to 12 months after diagnosis;
- no thoracic or abdominal surgery within the last 6 months;
- able to understand and follow verbal instructions;
Show all 10Show fewer
- no facial palsy, or mild facial palsy without limitation of labial occlusion;
- able to maintain a resting sitting posture without feet support for at least 30 seconds;
- no cognitive impairment (Montreal Cognitive Assessment (MoCA) score ≥ 26);
- able to independently walk at least 10 meters with or without an assistive device.
Who cannot join
- acute myocardial infarction or acute heart failure;
- acute pain in any part of the body;
- with respiratory illness or positive clinical signs of impaired respiratory function (such as shortness of breath, hypoxemia, chronic cough and sputum retention);
- with chronic cardiovascular dysfunction;
- Trunk Impairment Scale (TIS) score ≥ 20.
- patient with a nasal feeding tube, tracheal tube and/or any condition that prevents the measurement or the implementation of the study procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, None Selected
Fang LIU, +8613603049475, s1350035@live.hkmu.edu.hk
About this study
Official title: Effect of Inspiratory Muscle Training on Respiratory Function, Diaphragm Thickness, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial
This study is designed to explore the effects of a 4-week protocol of inspiratory muscle training (IMT) at 50% maximum inspiratory pressure (MIP) on respiratory function, diaphragm thickness, balance control, exercise capacity, and quality of life in people after stroke. To ascertain the effect of IMT on the relationship between diaphragm muscle contraction and activation of other trunk muscles, this study also explores whether any effect of the 4-week IMT protocol on balance control is associated with changes in the anticipatory posture adjustments (APAs) time - the onset time of postural muscles during a required task (e.g., the rapid shoulder flexion test).
- Conditions
- Stroke
- Being tested
- sham IMT, IMT-stable group (sitting on a stable surface), IMT-unstable group (sitting on an unstable surface), Conventional treatment
- Keywords
- Stroke, Inspiratory muscle training, Diaphragm, Balance control, Exercise capacity, Quality of life, Anticipatory postural adjustment time
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham IMTOther
with 10% maximum inspiratory pressure (MIP) as the training intensity, IMT will be conducted on a stable surface
IMT-stable group (sitting on a stable surface)Other
50% MIP as the training intensity, IMT will be conducted while sitting on a stable surface
IMT-unstable group (sitting on an unstable surface)Other
50% MIP as the training intensity, IMT will be conducted while sitting on an unstable surface
Conventional treatmentOther
Participants in all groups will receive a standardised conventional rehabilitation protocol. It includes limb range of motion, muscle tone reduction, strengthening and endurance of limb muscles, transfer skills, task-directed movements, general gait training, and activities of daily living training.
| Study group | Role | What they receive |
|---|---|---|
| Group A (sham IMT- stable group) | Sham comparator | conventional treatment + sham IMT Receives: Other: sham IMT; Other: Conventional treatment |
| Group B (IMT-stable group) | Experimental | conventional treatment + target IMT while sitting on a stable surface Receives: Other: IMT-stable group (sitting on a stable surface); Other: Conventional treatment |
| Group C (IMT-unstable group) | Experimental | conventional treatment + target IMT while sitting on an unstable surface Receives: Other: IMT-unstable group (sitting on an unstable surface); Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic thickness
The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).
Measured: baseline, after 4 weeks of intervention
Secondary outcomes (11)
Maximum Inspiratory Pressure (MIP)
Maximum Inspiratory Pressure (MIP) is a measure used in pulmonary function testing to assess the strength of the respiratory muscles, particularly the muscles used for inhalation. It will be measured using the spirometer.
Measured: baseline, after 4 weeks of intervention
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) is a measurement used in pulmonary function tests to assess lung function. It refers to the total volume of air that a person can forcibly exhale from their lungs after taking the deepest breath possible. It will be measured using the spirometer.
Measured: baseline, after 4 weeks of intervention
Forced Expiratory Volume in one second (FEV1)
Forced Expiratory Volume in one second (FEV1) measures the volume of air a person can forcibly exhale in the first second of a forced breath. It will be measured using the spirometer.
Measured: baseline, after 4 weeks of intervention
Sitting Balance
A force plate will be used to measure changes in the center of pressure during the performance of various tasks in sitting positions.
Measured: baseline, after 4 weeks of intervention
Trunk Impairment Scale (TIS)
The TIS is a rating scale used to measure static sitting balance, dynamic sitting balance, and trunk coordination. The total TIS score ranges from 0 to 23 points, with a higher score indicating better trunk function.
Measured: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Timed Up and Go Test (TUG)
TUG is a test to measure the time that a participant needs to stand up from a standard armchair, walk a short distance of about 3 meters, turn around, walk back to the chair, and sit down again.
Measured: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Falls efficacy scale international
The Falls Efficacy Scale-International (FES-I) is a questionnaire measuring fear of falling in older adults. It has 16 items, scored from 1 to 4, with higher scores indicating greater fear. It's used in clinical settings to assess fall risk and tailor interventions.
Measured: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
6-Minute Walk Test
The 6-Minute Walk Test (6MWT) measures how far someone can walk in six minutes. It assesses exercise capacity and mobility.
Measured: baseline, after 4 weeks of intervention
Stroke Impact Scale
The Chinese version of the Stroke Impact Scale 3.0 (SIS) will be used to measure the quality of life. A higher overall score suggests better physical, emotional, and social functioning, while a lower score may indicate more significant impairment or limitations.
Measured: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Trunk muscle activity
Surface electromyography (sEMG) (Noraxon USA, Inc., Scottsdale, AZ, USA) will be used to measure the bilateral muscle activity of the erector spinae, rectus abdominis, external oblique muscle, internal oblique muscle, and transversus abdominis during sitting balance tests on the force plate.
Measured: baseline, after 4 weeks of intervention
Anticipatory posture adjustments (APAs) time of trunk muscles
Participants will be requested to perform a rapid shoulder flexion test on the force plate. Surface electromyography (sEMG) (Noraxon USA, Inc., Scottsdale, AZ, USA) will be used to measure Anticipatory posture adjustments (APAs) time of trunk muscles.
Measured: baseline, after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start21 Feb 2025
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Jun 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 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
- NCT06640101
- Sponsor's protocol ID
- No.:HE-OT2023/13
- Status last verified
- Feb 2025
- First submitted
- 10 Oct 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu F, Jones AY, Tsang RC, Yam TT, Tsang WW. Inspiratory muscle training with balance challenge improves diaphragmatic thickness, respiratory function, balance, exercise capacity and quality of life in people after stroke: a randomised trial. J Physiother. 2026 Jan;72(1):42-52. doi: 10.1016/j.jphys.2025.12.004. Epub 2025 Dec 20.
PubMed 41423385
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Respiratory Function, Diaphragm Thickness, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06640101
- Acronym / sponsor ID
- No.:HE-OT2023/13
- Conditions
- Stroke
- Keywords
- Stroke, Inspiratory muscle training, Diaphragm, Balance control, Exercise capacity, Quality of life, Anticipatory postural adjustment time
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 15 Oct 2024 (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 is designed to explore the effects of a 4-week protocol of inspiratory muscle training (IMT) at 50% maximum inspiratory pressure (MIP) on respiratory function, diaphragm thickness, balance control, exercise capacity, and quality of life in people after stroke. To ascertain the effect of IMT on the relationship between diaphragm muscle contraction and activation of other trunk muscles, this study also explores whether any effect of the 4-week IMT protocol on balance control is associated with changes in the anticipatory posture adjustments (APAs) time - the onset time of postural muscles during a required task (e.g., the rapid shoulder flexion test).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (sham IMT- stable group) | Sham comparator | Other: sham IMT, Other: Conventional treatmentconventional treatment + sham IMT |
| Group B (IMT-stable group) | Experimental | Other: IMT-stable group (sitting on a stable surface), Other: Conventional treatmentconventional treatment + target IMT while sitting on a stable surface |
| Group C (IMT-unstable group) | Experimental | Other: IMT-unstable group (sitting on an unstable surface), Other: Conventional treatmentconventional treatment + target IMT while sitting on an unstable surface |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 40 years and < 80 years;
- breathing spontaneously;
- clinically diagnosed with ischemic and/or haemorrhagic stroke;
- duration of stroke from onset falls within 1 month to 12 months after diagnosis;
- no thoracic or abdominal surgery within the last 6 months;
Key exclusion criteria (6 listed)
- acute myocardial infarction or acute heart failure;
- acute pain in any part of the body;
- with respiratory illness or positive clinical signs of impaired respiratory function (such as shortness of breath, hypoxemia, chronic cough and sputum retention);
- with chronic cardiovascular dysfunction;
- Trunk Impairment Scale (TIS) score ≥ 20.
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 |
|---|---|---|
| sham IMTwith 10% maximum inspiratory pressure (MIP) as the training intensity, IMT will be conducted on a stable surface | Other | Group A (sham IMT- stable group) |
| IMT-stable group (sitting on a stable surface)50% MIP as the training intensity, IMT will be conducted while sitting on a stable surface | Other | Group B (IMT-stable group) |
| IMT-unstable group (sitting on an unstable surface)50% MIP as the training intensity, IMT will be conducted while sitting on an unstable surface | Other | Group C (IMT-unstable group) |
| Conventional treatmentParticipants in all groups will receive a standardised conventional rehabilitation protocol. It includes limb range of motion, muscle tone reduction, strengthening and endurance of limb muscles, transfer skills, task-directed movements, general gait training, and activities of daily living training. | Other | Group A (sham IMT- stable group), Group B (IMT-stable group), Group C (IMT-unstable group) |
Primary outcome
Diaphragmatic thickness
Time frame: baseline, after 4 weeks of intervention
The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).
11 secondary outcomes
Maximum Inspiratory Pressure (MIP)
Time frame: baseline, after 4 weeks of intervention
Forced Vital Capacity (FVC)
Time frame: baseline, after 4 weeks of intervention
Forced Expiratory Volume in one second (FEV1)
Time frame: baseline, after 4 weeks of intervention
Sitting Balance
Time frame: baseline, after 4 weeks of intervention
Trunk Impairment Scale (TIS)
Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Timed Up and Go Test (TUG)
Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Falls efficacy scale international
Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
6-Minute Walk Test
Time frame: baseline, after 4 weeks of intervention
Stroke Impact Scale
Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Trunk muscle activity
Time frame: baseline, after 4 weeks of intervention
Anticipatory posture adjustments (APAs) time of trunk muscles
Time frame: baseline, after 4 weeks of intervention
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 24 Feb 2025.
- Derived from this study: PubMed 41423385Liu F, Jones AY, Tsang RC, Yam TT, Tsang WW. Inspiratory muscle training with balance challenge improves diaphragmatic thickness, respiratory function, balance, exercise capacity and quality of life in people after stroke: a randomised trial. J Physiother. 2026 Jan;72(1):42-52. doi: 10.1016/j.jphys.2025.12.004. Epub 2025 Dec 20.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMT-stable group (sitting on a stable surface), IMT-unstable group (sitting on an unstable surface) and Conventional treatment in people with Stroke, run by Hong Kong Metropolitan University at 1 site in China.
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 10 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Fang LIU (+86 13603049475, s1350035@live.hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic thickness (time frame: baseline, after 4 weeks of intervention). 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 NCT06640101, 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 24 Feb 2025.