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Functional Inspiratory Muscle Training for Gait Recovery in Patients With Chronic Stroke

21 juillet 2026 mis à jour par: Shimaa Taha Mohamed Taha, Cairo University

Effect of Functional Inspiratory Muscle Training on Spatiotemporal Gait Parameters in Patients With Chronic Stroke

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Shimaa Taha, PhD
  • Numéro de téléphone: +201021088610 +201021088610
  • E-mail: shimaa.taha@cu.edu.eg

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Functional Inspiratory Muscle Training
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.
Comparateur actif: 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.
Comportemental: Conventional Inspiratory Muscle Training
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Gait Speed
Délai: Time Frame: Baseline (Day 1) and end of Week 8
Gait speed assessed using the STEADYS gait assessment system and reported in meters per second (m/s).
Time Frame: Baseline (Day 1) and end of Week 8
Change in Cadence
Délai: Baseline (Day 1) and end of Week 8
Cadence assessed using the STEADYS gait assessment system and reported in steps per minute (steps/min).
Baseline (Day 1) and end of Week 8
Change in Stance Time
Délai: Baseline (Day 1) and end of Week 8
Stance 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
Change in Swing Time
Délai: Baseline (Day 1) and end of Week 8
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
Change in Double Support Time
Délai: Baseline (Day 1) and end of Week 8
Double support 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
Change in Stride Length
Délai: Baseline (Day 1) and end of Week 8
Stride length assessed using the STEADYS gait assessment system and reported in meters (m).
Baseline (Day 1) and end of Week 8

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Functional Exercise Capacity
Délai: 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.
Baseline (Day 1) and end of Week 8
Change in Health-Related Quality of Life
Délai: 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.
Baseline (Day 1) and end of Week 8

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cairo University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

20 décembre 2026

Dates d'inscription aux études

Première soumission

16 juillet 2026

Première soumission répondant aux critères de contrôle qualité

21 juillet 2026

Première publication (Réel)

27 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • CU-PT-FIMT-STROKE-2026

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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