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