AzTrials
AzTrials

DysarthriaACURESNCT07435155

ACURES: Acoustic and Respiratory Parameters for Dysarthria Assessment

An observational study of Dysarthria and Acquired Brain Injury, run by University of Salamanca at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dysarthria, Acquired Brain Injury
How many people
100 participants
Where
1 siteSpain
Study dates
15 Oct 2025to 15 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will include adult participants aged 18 years or older with a diagnosis of acquired brain injury (ABI), including stroke, traumatic brain injury, or brain tumor. Participants will be recruited from hospitals, clinics, and patient associations in Salamanca, Spain. Both individuals with and without dysarthria secondary to ABI will be included. All participants must have preserved cognitive function (Mini-Mental State Examination score ≥ 24) and be able to provide written informed consent or have a legally authorized representative provide consent if necessary. Participants with chronic respiratory diseases, significant hearing impairments, additional neurological or neurodegenerative disorders, pre-existing voice disorders, severe aphasia, or persistent pharyngeal symptoms will be excluded. The sample size is estimated to be between 97 and 150 participants, considering a dysarthria prevalence of 60% in the ABI population, a 95% confidence level, and a margin of err

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

AHMED ARGOUBI, Speech Language Pathologist contact

+34 652555591

ahmedargoubi@usal.es

Ana-María Martín-Nogueras, Investigator/ Profesor contact

+34 669284767

anamar@usal.es

Spain1 site, 1 recruiting

  • University of Salamanca

    Salamanca, Salamanca, 34007

    AHMED ARGOUBI, Speech Language Pathologist, +34 652555591, ahmedargoubi@usal.es

    Recruiting

Other trials in Spain

About this study

Official title: Evaluating Dysarthria Through Acoustic and Respiratory Parameters: A Clinical Protocol

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?
Read more

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.

Read the detailed description

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.

Keywords
acquired brain injury, dysarthria, Spirometry, Speech therapy, voice disorders, Phono-respiratory assessment
Medical subject headings
Dysarthria, Brain Injuries, Communication Disorders, Voice Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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)

    Measured: Baseline

  2. Vowel Space Area (VSA)

    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.

    Measured: Baseline

  3. Formant Centralization Ratio (FCR)

    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.

    Measured: Baseline

Secondary outcomes (12)

  1. Median Fundamental Frequency (F₀)

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

    Measured: Baseline

  2. Jitter

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

    Measured: Baseline

  3. Shimmer

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

    Measured: Baseline

  4. Harmonics-to-Noise Ratio (HNR)

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

    Measured: Baseline

  5. Maximum Phonation Time (MPT)

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

    Measured: Baseline

  6. Maximum Emission Time (MET)

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

    Measured: Baseline

  7. s/z Ratio

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

    Measured: Baseline

  8. Vital Capacity (VC)

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

    Measured: Baseline

  9. Forced Vital Capacity (FVC)

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

    Measured: Baseline

  10. Forced Expiratory Volume in One Second (FEV₁)

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

    Measured: Baseline

  11. Maximum Voluntary Ventilation (MVV)

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

    Measured: Baseline

  12. FEV₁/FVC Ratio

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start15 Oct 2025
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion15 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07435155
Sponsor's protocol ID
ACURES-2025-DCA
Acronym
ACURES
Status last verified
Dec 2025
First submitted
6 Dec 2025
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 42049296

Questions about this trial

What is this clinical trial studying?

An observational study of Dysarthria and Acquired Brain Injury, run by University of Salamanca at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AHMED ARGOUBI, Speech Language Pathologist (+34 652555591, ahmedargoubi@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dysarthria severity assessed by the Frenchay Dysarthria Assessment-2 (FDA-2) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07435155, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in