Inspiratory Muscle Training After Stroke

Objective: To investigate and compare the efficacy of a 6-week, supervised respiratory training program using the AiroFit PRO™ mobile respiratory trainer against traditional Pursed-Lips Breathing exercises in individuals with hemiplegia. Study Design: A single-blind, two-arm, randomized controlled trial. Participants: Ambulatory adults with stable hemiplegia (≥3 months post-stroke), who are medically stable and able to follow commands. Interventions: Participants will be randomly assigned to one of two groups: Experimental Group: Will perform Inspiratory Muscle Training using the AiroFit PRO™ device for 15 minutes/day, 5 days/week, for 6 weeks. The intensity will be progressively increased. Active Control Group: Will perform Pursed-Lips Breathing exercises for an identical duration and frequency. Primary Outcomes: Changes in pulmonary function tests, including Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), and Maximal Inspiratory Pressure (MIP). Significance: This study will provide high-level evidence on the utility of smart, device-guided respiratory training as a novel component of neurorehabilitation, potentially offering a more effective strategy to improve respiratory health and overall recovery in hemiplegic patients compared to standard breathing exercises.

Inclusion Criteria: * Clinical Diagnosis: A confirmed diagnosis of unilateral hemiplegia or hemiparesis (e.g., secondary to ischemic or hemorrhagic stroke), sustained at least 3 months prior to enrollment. * Age: Aged between 18 and 80 years. * Stable Medical Condition: Medically stable, as determined by the treating physician, with no changes in their primary rehabilitation regimen or medication for spasticity/neurological condition in the past 4 weeks. * Cognitive \& Communication Ability: Sufficient cognitive function and language comprehension to understand and follow simple commands and provide informed consent, as assessed by a Mini-Mental State Examination (MMSE) score of ≥ 24 (or a similar validated tool). * Respiratory Status: Able to perform forced expiratory maneuvers for spirometry and tolerate the breathing training protocols. Exclusion Criteria: * Pre-existing, significant respiratory diseases (e.g., severe COPD, asthma, pulmonary fibrosis, active lung cancer). * Unstable cardiovascular conditions (e.g., uncontrolled hypertension, unstable angina, recent myocardial infarction within the past 6 months, congestive heart failure NYHA Class III or IV). * Inability to achieve a proper seal with the breathing trainer mouthpiece due to facial muscle weakness or other anatomical reasons. * Inability to commit to the 6-week training and assessment schedule