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

NCT ID: NCT06877338

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-10-15

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Loaded breathing on stable and unstable surfaces

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong Kong Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

LIU FANG

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

No: HE-OT2023/13

Identifier Type: -

Identifier Source: org_study_id