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Not Yet Recruiting NCT07727902

Functional Inspiratory Muscle Training for Gait Recovery in Patients With Chronic Stroke

Conditions: Chronic Stroke Patient, Stroke Rehabilitation

Sex: All
Ages: 55 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Cairo University

Summary

The purpose of this randomized controlled trial is to evaluate the effect of functional inspiratory muscle training (F-IMT) on spatiotemporal gait parameters in patients with chronic stroke. Sixty participants with chronic stroke will be randomly assigned to either a functional inspiratory muscle training group or a conventional inspiratory muscle training group. Both groups will receive the same conventional rehabilitation program for 8 weeks. The primary outcome is spatiotemporal gait parameters measured using the STEADYS gait assessment system. Secondary outcomes include exercise capacity assessed by the Six-Minute Walk Test (6MWT) and health-related quality of life assessed using the EuroQol Five-Dimension (EQ-5D) questionnaire.

Eligibility Criteria

Inclusion Criteria: * Patients aged between 55 and 65 years. * Both male and female participants. * Chronic stroke patients (\>6 months after stroke onset), including ischemic or hemorrhagic stroke confirmed by neuroimaging. * Moderate gait impairment with gait speed ranging from 0.4 to 0.8 m/s. * Ability to understand instructions and communicate sufficiently to participate in the study procedures. * Breathing spontaneously without ventilatory support. * No thoracic or abdominal surgery within the previous 6 months. * No facial palsy, or mild facial palsy without limitation of labial occlusion. * Ability to walk independently for at least 10 meters with or without an assistive device. * Willingness to participate and provide written informed consent. Exclusion Criteria: * Unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled hypertension, decompensated heart failure). * Uncontrolled metabolic disease or poorly controlled diabetes mellitus. * Severe pulmonary disease or respiratory impairment (e.g., severe COPD, hypoxemia, chronic cough, or sputum retention). * Active malignancy. * Presence of nasal feeding tube, tracheostomy tube, or any condition preventing implementation of the study procedures. * Severe musculoskeletal disorders affecting gait performance (e.g., lower limb fracture, severe osteoarthritis, or amputation). * Significant cognitive or communication impairment preventing reliable participation. * Severe spasticity (Modified Ashworth Scale \>3) or fixed contractures. * Other neurological disorders affecting gait (e.g., Parkinson's disease, multiple sclerosis, spinal cord injury). * Severe obesity (BMI ≥35 kg/m²) that may interfere with gait assessment or exercise performance. * Previous participation in inspiratory muscle training programs.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07727902). StuddyBuddy aggregates publicly available trial information.