Effects of Inspiratory Muscle Training on Stroke Rehabilitation Outcomes
NCT ID: NCT06640101
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2025-02-21
2026-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A (sham IMT- stable group)
conventional treatment + sham IMT
sham IMT
with 10% maximum inspiratory pressure (MIP) as the training intensity, IMT will be conducted on a stable surface
Conventional treatment
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.
Group B (IMT-stable group)
conventional treatment + target IMT while sitting on a stable surface
IMT-stable group (sitting on a stable surface)
50% MIP as the training intensity, IMT will be conducted while sitting on a stable surface
Conventional treatment
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.
Group C (IMT-unstable group)
conventional treatment + target IMT while sitting on an unstable surface
IMT-unstable group (sitting on an unstable surface)
50% MIP as the training intensity, IMT will be conducted while sitting on an unstable surface
Conventional treatment
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.
Interventions
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sham IMT
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)
50% MIP as the training intensity, IMT will be conducted while sitting on a stable surface
IMT-unstable group (sitting on an unstable surface)
50% MIP as the training intensity, IMT will be conducted while sitting on an unstable surface
Conventional treatment
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.
Eligibility Criteria
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Inclusion Criteria
* 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;
* 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.
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
No
Sponsors
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Hong Kong Metropolitan University
OTHER
Responsible Party
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LIU FANG
Principal Investigator
Locations
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Shenzhen Second People's Hospital
Shenzhen, None Selected, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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No.:HE-OT2023/13
Identifier Type: -
Identifier Source: org_study_id
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