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

NCT06877338 | Not Yet Recruiting

• 1 other identifier: No: HE-OT2023/13
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (3)

• Muscle activation of the sternocleidomastoid muscle

  Day 1

• Muscle activation of the trunk muscles

  Day 1

• Perceived Exertion Borg scale

  Day 1

Interventions

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).

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People diagnosed with stroke who meet the criteria will be invited to participate in the study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 14, 2025
• Study Start: March 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: October 15, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03