Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07276477

Inspiratory Muscle Training After Stroke

Led by Uşak University · Updated on 2026-01-14

54

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Inspiratory Muscle Training After Stroke

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of unilateral hemiplegia or hemiparesis (e.g., due to stroke) lasting at least 3 months
  • Age between 18 and 80 years
  • Medically stable with no changes in rehabilitation or neurological medication in the past 4 weeks
  • Sufficient cognitive ability and language skills to follow commands and give informed consent (e.g., MMSE score 63 24)
  • Able to perform forced expiratory maneuvers for spirometry and tolerate breathing training protocols
Not Eligible

You will not qualify if you...

  • Significant pre-existing respiratory diseases (e.g., severe COPD, asthma, pulmonary fibrosis, active lung cancer)
  • Unstable cardiovascular conditions (e.g., uncontrolled hypertension, unstable angina, recent heart attack within 6 months, advanced heart failure)
  • Unable to properly seal the breathing trainer mouthpiece due to facial muscle weakness or anatomical reasons
  • Unable to commit to the 6-week training and assessment schedule

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Usak

Uşak, Turkey (Türkiye), 64200

Actively Recruiting

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Research Team

A

Ali Y Karahan, Professor

CONTACT

M

Mustafa Sengul, Asst. Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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