ACURES: Acoustic and Respiratory Parameters for Dysarthria Assessment

NCT07435155 | Recruiting DMC

• 1 other identifier: ACURES-2025-DCA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dysarthria; Acquired Brain Injury

Keywords

acquired brain injury; dysarthria; Spirometry; Speech therapy; voice disorders; Phono-respiratory assessment

Outcome Measures

Primary Outcomes (3)

• 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)

  Baseline

• 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.

  Baseline

• 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.

  Baseline

Secondary Outcomes (12)

• Median Fundamental Frequency (F₀)

  Baseline

• Jitter

  Baseline

• Shimmer

  Baseline

• Harmonics-to-Noise Ratio (HNR)

  Baseline

• Maximum Phonation Time (MPT)

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 34007, Spain

RECRUITING

MeSH Terms

Conditions

Dysarthria; Brain Injuries; Communication Disorders; Voice Disorders

Condition Hierarchy (Ancestors)

Articulation Disorders; Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurodevelopmental Disorders; Mental Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ana-María Martín Nogueras, Investigator/ Profesor

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Ana-María Martín Nogueras

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED ARGOUBI, Speech Language Pathologist

CONTACT

+34 652555591; ahmedargoubi@usal.es

Ana-María Martín-Nogueras, Investigator/ Profesor

CONTACT

+34 669284767; anamar@usal.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator/ Profesor

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: February 27, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-12

Locations

ES (1)