About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Device-Guided Inspiratory Muscle Training
Other interventionThe AiroFit™ PRO mobile respiratory trainer will be used.
Pursed-Lips Breathing Training
Other interventionTechnique-based breathing exercise
Concomitant Care
Other interventionAll participants will continue to receive their standard conventional neurorehabilitation therapy (e.g., physiotherapy, occupational therapy) as prescribed by their physician. This concomitant care will be documented for both groups to ensure equivalence.
Treatment groups
Trial outcomes
Primary outcomes
Forced Vital Capacity (FVC)
The maximum volume of air, in liters, that a participant can forcibly and completely exhale after taking the deepest possible breath. It reflects the overall function and size of the lungs.
Forced Expiratory Volume in 1 second (FEV1)
The maximum volume of air, in liters, that a participant can forcibly exhale in the first second of the FVC maneuver. It is a key indicator of airway obstruction.
FEV1/FVC Ratio
The ratio of FEV1 to FVC, expressed as a percentage. This is the primary index used to diagnose and categorize the presence and severity of obstructive lung defects. A reduced value indicates airflow limitation
Forced Expiratory Flow 25-75% (FEF25-75)
The average rate of airflow, in liters/second, during the middle half (25% to 75%) of the FVC maneuver. It is considered a sensitive measure of airflow in the smaller peripheral airways.
Secondary outcomes
The Six-Minute Walk Test
The Six-Minute Walk Test (6MWT) is a functional walking test in which the distance that a client can walk within six minutes is evaluated. This test has been used to assess individuals with stroke.
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