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NCT Number: NCT07435155

ACURES: Acoustic and Respiratory Parameters for Dysarthria Assessment

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Dysarthria severity assessed by the Frenchay Dysarthria Assessment-2 (FDA-2)

    Time frame: Baseline

    Severity of dysarthria assessed using the Frenchay Dysarthria Assessment-2 (FDA-2), reported as a total score reflecting overall speech motor impairment.

    Unit of Measure: FDA-2 total score (ordinal scale)

  2. Vowel Space Area (VSA)

    Time frame: Baseline

    Vowel Space Area calculated from the first and second formant frequencies (F1-F2) of the corner vowels (/i/, /a/, /u/), expressed in kHz², reflecting articulatory working space and articulatory precision.

  3. Formant Centralization Ratio (FCR)

    Time frame: Baseline

    Formant Centralization Ratio derived from mean formant frequencies of the vowels (/a, e, i, o, u/), expressed as a dimensionless ratio, reflecting vowel centralization and articulatory impairment.

Secondary outcomes

  1. Median Fundamental Frequency (F₀)

    Time frame: Baseline

    Median fundamental frequency (F0) of sustained /a/ vowel phonation, expressed in Hertz (Hz).

  2. Jitter

    Time frame: Baseline

    Short-term frequency perturbation of sustained /a/ vowel phonation, expressed as a percentage (%).

  3. Shimmer

    Time frame: Baseline

    Short-term amplitude perturbation of sustained /a/ vowel phonation, expressed as a percentage (%).

  4. Harmonics-to-Noise Ratio (HNR)

    Time frame: Baseline

    Ratio between noise and harmonic components of the sustained /a/ vowel phonation, expressed in decibels (dB).

  5. Maximum Phonation Time (MPT)

    Time frame: Baseline

    Maximum duration of sustained vowel phonation (/a/) measured during a standardized task, expressed in seconds (s).

  6. Maximum Emission Time (MET)

    Time frame: Baseline

    Maximum duration of sustained fricative emission measured during a standardized task, expressed in seconds (s).

  7. s/z Ratio

    Time frame: Baseline

    Ratio between maximum sustained durations of voiceless (/s/) and voiced (/z/) fricative emissions, expressed as a dimensionless ratio.

  8. Vital Capacity (VC)

    Time frame: Baseline

    Vital capacity measured by standard spirometry, defined as the maximum volume of air exhaled following a maximal inhalation, expressed in litres (L).

  9. Forced Vital Capacity (FVC)

    Time frame: Baseline

    Forced vital capacity measured by standard spirometry during a forced expiratory manoeuvre, expressed in litres (L).

  10. Forced Expiratory Volume in One Second (FEV₁)

    Time frame: Baseline

    Forced expiratory volume in the first second measured by standard spirometry, expressed in litres (L).

  11. Maximum Voluntary Ventilation (MVV)

    Time frame: Baseline

    Maximum voluntary ventilation measured by standard spirometry during rapid and deep breathing, expressed in litres per minute (L/min).

  12. FEV₁/FVC Ratio

    Time frame: Baseline

    Ratio between forced expiratory volume in one second and forced vital capacity, expressed as a percentage (%).

Study contacts

Contact information is provided by the study sponsor or research team.

AHMED ARGOUBI, Speech Language Pathologist

CONTACT

[email protected]

+34 652555591

Ana-María Martín-Nogueras, Investigator/ Profesor

CONTACT

[email protected]

+34 669284767

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

Evaluating Dysarthria Through Acoustic and Respiratory Parameters: A Clinical Protocol

Acronym: ACURES

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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