Functional Inspiratory Muscle Training for Gait Recovery in Patients With Chronic Stroke
Starting soon · Not applicable
Conditions studied: Chronic Stroke Patient, Stroke Rehabilitation
In brief
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.
Key facts
- Study ID
- NCT07727902
- Run by
- Cairo University
- People needed
- 60
- Starts
- 2026-08-01
- Expected to finish
- 2026-12-20
- Last updated by the study team
- 2026-07-27
Who can join
Age: 55 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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