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

21 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Gait Speed
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Functional Exercise Capacity
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cairo University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

20 dicembre 2026

Date di iscrizione allo studio

Primo inviato

16 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2026

Primo Inserito (Effettivo)

27 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • CU-PT-FIMT-STROKE-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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