Functional Inspiratory Muscle Training for Gait Recovery in Patients With Chronic Stroke
Effect of Functional Inspiratory Muscle Training on Spatiotemporal Gait Parameters in Patients With Chronic Stroke
Přehled studie
Postavení
Detailní popis
Stroke is a leading cause of long-term disability worldwide and is frequently associated with persistent impairments in walking ability. Patients with chronic stroke commonly demonstrate reduced gait speed, shorter stride length, impaired gait symmetry, prolonged double-support time, and decreased functional mobility. These gait abnormalities are associated with impaired trunk control, respiratory muscle weakness, reduced exercise tolerance, and diminished quality of life. Although conventional rehabilitation improves motor function, many patients continue to experience limitations in walking performance.
Inspiratory muscle training (IMT) has been shown to improve inspiratory muscle strength, pulmonary function, exercise capacity, and trunk stability in individuals with neurological disorders. Functional inspiratory muscle training (F-IMT) integrates inspiratory muscle training with functional rehabilitation exercises, allowing simultaneous activation of respiratory and postural muscles during task-oriented activities. This integrated approach may enhance motor control and walking performance beyond conventional IMT alone.
This study is a prospective, single-center, randomized controlled trial involving 60 participants with chronic stroke. Eligible participants will be randomly allocated in a 1:1 ratio to one of two intervention groups. The intervention group will receive functional inspiratory muscle training using a Threshold IMT device integrated with functional rehabilitation exercises at an intensity of 50% of maximal inspiratory pressure (MIP), five sessions per week for 8 weeks. The control group will receive conventional inspiratory muscle training using the same device, training intensity, frequency, and duration without integration into functional activities. Both groups will receive an identical standardized conventional rehabilitation program throughout the intervention period.
The primary outcome will be changes in spatiotemporal gait parameters measured using the STEADYS gait assessment system, including gait speed, cadence, stance time, swing time, double-support time, and stride length. Secondary outcomes will include functional exercise capacity measured using the Six-Minute Walk Test (6MWT) and health-related quality of life measured using the EuroQol Five-Dimension (EQ-5D) questionnaire. Outcome assessments will be performed at baseline and after completion of the 8-week intervention.
The findings of this trial will provide evidence regarding the effectiveness of functional inspiratory muscle training as an adjunct to conventional rehabilitation for improving gait performance, exercise capacity, and quality of life in individuals with chronic stroke.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Shimaa Taha, PhD
- Telefonní číslo: +201021088610 +201021088610
- E-mail: shimaa.taha@cu.edu.eg
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
- Ability to understand instructions and communicate sufficiently to participate in the study procedures.
- Breathing spontaneously without ventilatory support.
- No thoracic or abdominal surgery within the previous 6 months.
- No facial palsy, or mild facial palsy without limitation of labial occlusion.
- Ability to walk independently for at least 10 meters with or without an assistive device.
- Willingness to participate and provide written informed consent.
Exclusion Criteria:
- 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.
- Presence of nasal feeding tube, tracheostomy tube, or any condition preventing implementation of the study procedures.
- Severe musculoskeletal disorders affecting gait performance (e.g., lower limb fracture, severe osteoarthritis, or amputation).
- Significant cognitive or communication impairment preventing reliable participation.
- Severe spasticity (Modified Ashworth Scale >3) or fixed contractures.
- Other neurological disorders affecting gait (e.g., Parkinson's disease, multiple sclerosis, spinal cord injury).
- Severe obesity (BMI ≥35 kg/m²) that may interfere with gait assessment or exercise performance.
- Previous participation in inspiratory muscle training programs.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Functional Inspiratory Muscle Training Group
Participants will receive functional inspiratory muscle training combined with a standardized conventional rehabilitation program.
Functional inspiratory muscle training integrates inspiratory muscle loading with functional activities and will be performed using the Threshold IMT device at 50% of maximal inspiratory pressure (MIP), 5 days per week for 8 weeks.
Each session will last approximately 30 minutes (3 sets of 10-15 repetitions).
Participants will also receive conventional rehabilitation including range of motion exercises, muscle tone management, strengthening and endurance training, transfer training, task-oriented activities, gait training, and activities of daily living training.
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Functional 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.
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Aktivní komparátor: Conventional Inspiratory Muscle Training Group
Participants will receive conventional inspiratory muscle training combined with the same standardized conventional rehabilitation program.
Inspiratory muscle training will be performed using the Threshold IMT device at 50% of maximal inspiratory pressure (MIP), 5 days per week for 8 weeks.
Each session will last approximately 30 minutes (3 sets of 10-15 repetitions).
The conventional rehabilitation program will include range of motion exercises, muscle tone management, strengthening and endurance training, transfer training, task-oriented activities, gait training, and activities of daily living training.
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Conventional 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Gait Speed
Časové okno: Time Frame: Baseline (Day 1) and end of Week 8
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Gait speed assessed using the STEADYS gait assessment system and reported in meters per second (m/s).
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Time Frame: Baseline (Day 1) and end of Week 8
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Change in Cadence
Časové okno: Baseline (Day 1) and end of Week 8
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Cadence assessed using the STEADYS gait assessment system and reported in steps per minute (steps/min).
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Baseline (Day 1) and end of Week 8
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Change in Stance Time
Časové okno: Baseline (Day 1) and end of Week 8
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Stance time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
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Baseline (Day 1) and end of Week 8
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Change in Swing Time
Časové okno: Baseline (Day 1) and end of Week 8
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Swing time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
|
Baseline (Day 1) and end of Week 8
|
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Change in Double Support Time
Časové okno: Baseline (Day 1) and end of Week 8
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Double support time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.
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Baseline (Day 1) and end of Week 8
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Change in Stride Length
Časové okno: Baseline (Day 1) and end of Week 8
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Stride length assessed using the STEADYS gait assessment system and reported in meters (m).
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Baseline (Day 1) and end of Week 8
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Functional Exercise Capacity
Časové okno: Baseline (Day 1) and end of Week 8
|
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.
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Baseline (Day 1) and end of Week 8
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Change in Health-Related Quality of Life
Časové okno: Baseline (Day 1) and end of Week 8
|
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.
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Baseline (Day 1) and end of Week 8
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- CU-PT-FIMT-STROKE-2026
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