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
Qualifiers
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
Treatments tested in this trial
- Device-Guided Inspiratory Muscle Training
- Pursed-Lips Breathing Training
- Concomitant Care