Functional Inspiratory Muscle Training for Gait Recovery in Patients With Chronic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-65
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Functional Inspiratory Muscle Training
BehavioralFunctional inspiratory muscle training combines inspiratory muscle loading with functional activities to improve respiratory muscle performance, trunk stability, and functional mobility. Training will be performed at 50% of maximal inspiratory pressure using a Threshold IMT device for 30 minutes per session, 5 days per week, for 8 weeks.
Conventional Inspiratory Muscle Training
BehavioralConventional inspiratory muscle training will be performed using a Threshold IMT device at 50% of maximal inspiratory pressure for 30 minutes per session, 5 days per week, for 8 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Functional Inspiratory Muscle Training GroupExperimental treatment 1 intervention
Group B: Conventional Inspiratory Muscle Training GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Gait Speed
Gait speed assessed using the STEADYS gait assessment system and reported in meters per second (m/s).
Time frame
Time Frame: Baseline (Day 1) and end of Week 82
Change in Cadence
Cadence assessed using the STEADYS gait assessment system and reported in steps per minute (steps/min).
Time frame
Baseline (Day 1) and end of Week 83
Change in Stance Time
Stance time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
Time frame
Baseline (Day 1) and end of Week 84
Change in Swing Time
Swing time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
Time frame
Baseline (Day 1) and end of Week 8Secondary outcomes
1
Change in Functional Exercise Capacity
Functional exercise capacity assessed using the Six-Minute Walk Test (6MWT). The outcome is the total distance walked during 6 minutes, reported in meters (m). Higher values indicate better functional exercise capacity.
Time frame
Baseline (Day 1) and end of Week 82
Change in Health-Related Quality of Life
Health-related quality of life assessed using the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L). The EQ-5D-5L Index Score ranges from less than 0 (health states worse than death) to 1.0 (perfect health). Higher scores indicate better health-related quality of life.
Time frame
Baseline (Day 1) and end of Week 8Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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