Menu
Recruiting NCT06640101

Effects of Inspiratory Muscle Training on Stroke Rehabilitation Outcomes

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sham IMT, IMT-stable group (sitting on a stable surface), IMT-unstable group (sitting on an unstable surface), Conventional treatment.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Other sham IMT
    with 10% maximum inspiratory pressure (MIP) as the training intensity, IMT will be conducted on a stable surface
  • Other 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 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 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.

Primary outcome measures

  • Diaphragmatic thickness [Time frame: baseline, after 4 weeks of intervention]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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;
  • 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Shenzhen Second People's Hospital — Shenzhen

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. PMID 41423385

Identifiers

NCT: NCT06640101 · No.:HE-OT2023/13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗