ACURES: Acoustic and Respiratory Parameters for Dysarthria Assessment

Официальное название

Evaluating Dysarthria Through Acoustic and Respiratory Parameters: A Clinical Protocol

Обзор

The goal of this observational study is to describe speech and breathing patterns in adults after acquired brain injury (ABI) and understand how these patterns relate to the presence, severity, and type of dysarthria. The main questions it aims to answer are: * What changes in voice and breathing are observed in adults with dysarthria after ABI? * Can combining acoustic, respiratory, and clinical assessments help identify dysarthria severity and subtype? Participants will: * Have their speech recorded to measure voice and articulation features, such as pitch, clarity, and the ability to sustain sounds. * Perform breathing tests using a spirometer to assess lung function. * Complete the Frenchay Dysarthria Assessment-2 (FDA-2), adapted to Spanish, to classify dysarthria type and severity. About 97 to 101 participants will take part. The results will help speech therapists better detect, evaluate, and treat dysarthria in adults after brain injury.

Подробное описание

This cross-sectional observational study aims to characterise acoustic, respiratory, and clinical speech parameters in adults with acquired brain injury (ABI) and to examine their associations with the presence and severity of dysarthria. The study is limited to baseline assessment and does not include therapeutic intervention or longitudinal follow-up.

Participants complete a standardised evaluation protocol conducted in a controlled clinical setting. All assessments are performed within a short and predefined evaluation period to minimise fatigue and contextual variability. The protocol comprises three assessment sessions: (1) acoustic and aerodynamic speech evaluation based on sustained phonation vowels /a/, /i/, /u/, /o/ and connected speech tasks; (2) objective assessment of respiratory function using spirometry; and (3) clinical assessment of dysarthria using the Frenchay Dysarthria Assessment-2 (FDA-2).

Speech recordings are obtained under standardised conditions to ensure consistency across participants and reliable extraction of acoustic measures. Respiratory assessments are performed according to established international guidelines to ensure validity and reproducibility. Data from acoustic, respiratory, and clinical assessments are analysed jointly to explore associations between phonorespiratory function and dysarthria severity in adults with ABI.

Первичные конечные точки

• Dysarthria severity assessed by the Frenchay Dysarthria Assessment-2 (FDA-2) [Срок оценки: Baseline]
• Vowel Space Area (VSA) [Срок оценки: Baseline]
• Formant Centralization Ratio (FCR) [Срок оценки: Baseline]

Вторичные конечные точки (12)

• Median Fundamental Frequency (F₀) [Срок оценки: Baseline]
• Jitter [Срок оценки: Baseline]
• Shimmer [Срок оценки: Baseline]
• Harmonics-to-Noise Ratio (HNR) [Срок оценки: Baseline]
• Maximum Phonation Time (MPT) [Срок оценки: Baseline]
• Maximum Emission Time (MET) [Срок оценки: Baseline]
• s/z Ratio [Срок оценки: Baseline]
• Vital Capacity (VC) [Срок оценки: Baseline]
• Forced Vital Capacity (FVC) [Срок оценки: Baseline]
• Forced Expiratory Volume in One Second (FEV₁) [Срок оценки: Baseline]
• Maximum Voluntary Ventilation (MVV) [Срок оценки: Baseline]
• FEV₁/FVC Ratio [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Adults aged 18 years or older at the time of enrollment.

Diagnosed with acquired brain injury (ABI), including:

• Stroke
• Traumatic brain injury (TBI)
• Brain tumor
• Ability to provide written informed consent (or via a legally authorized representative if necessary).
• Cognitive function preserved, defined as a Mini-Mental State Examination (MMSE) score ≥ 24.

Критерии исключения

• History of chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD) or asthma.
• History of hearing impairments that could affect speech evaluation.
• Presence of additional neurological or neurodegenerative disorders other than the acquired brain injury.
• History of voice disorders or dysphonia prior to the acquired brain injury.
• Presence of persistent pharyngeal symptoms, such as mucus, secretions, or foreign body sensation, which may interfere with speech assessment.
• Participants unable to comply with the assessment protocol or complete the required sessions.
• Presence of apahasia that prevents participation in speech tasks, such as reading, repetition, or spontaneous speech priduction.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• University of Salamanca — Salamanca

Публикации

• Argoubi A, Diez Garcia R, Hernandez Moreda B, Martin-Nogueras AM. Integrated acoustic and respiratory biomarkers of dysarthria in acquired brain injury: protocol for a cross-sectional study. BMJ Open. 2026 Apr 28;16(4):e115669. doi: 10.1136/bmjopen-2025-115669. PMID 42049296

Идентификаторы

NCT: NCT07435155 · ACURES-2025-DCA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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