Effects of Inspiratory Muscle Training on Stroke Rehabilitation Outcomes

Hong Kong Metropolitan University

Status: Enrolling

Conditions: Stroke

Treatments: Other: IMT-stable group (sitting on a stable surface); Other: IMT-unstable group (sitting on an unstable surface); Other: sham IMT; Other: Conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06640101

No.:HE-OT2023/13

Details and patient eligibility

About

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).

Enrollment: 84 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 3 patient groups

Group A (sham IMT- stable group)

Sham Comparator group

Description:

conventional treatment + sham IMT

Treatment:

Other: Conventional treatment

Other: sham IMT

Group B (IMT-stable group)

Experimental group

Description:

conventional treatment + target IMT while sitting on a stable surface

Treatment:

Other: Conventional treatment

Other: IMT-stable group (sitting on a stable surface)

Group C (IMT-unstable group)

Experimental group

Description:

conventional treatment + target IMT while sitting on an unstable surface

Treatment:

Other: Conventional treatment

Other: IMT-unstable group (sitting on an unstable surface)