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NCT Number: NCT06877338

Inspiratory and Trunk Muscle Activity During IMT on Stable and Unstable Surfaces in Stroke Patients

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loaded breathing on stable and unstable surfaces

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Registry information

Official study title

Inspiratory and Trunk Muscle Activity During Inspiratory Muscle Training on Stable and Unstable Surfaces in People After Stroke

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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