ACURES: Acoustic and Respiratory Parameters for Dysarthria Assessment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Salamanca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older at the time of enrollment.
Stroke
Traumatic brain injury (TBI)
Brain tumor
Disqualifiers
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.
Trial 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
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
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)
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
BaselineSecondary outcomes
1
Median Fundamental Frequency (F₀)
Median fundamental frequency (F0) of sustained /a/ vowel phonation, expressed in Hertz (Hz).
Time frame
Baseline2
Jitter
Short-term frequency perturbation of sustained /a/ vowel phonation, expressed as a percentage (%).
Time frame
Baseline3
Shimmer
Short-term amplitude perturbation of sustained /a/ vowel phonation, expressed as a percentage (%).
Time frame
Baseline4
Harmonics-to-Noise Ratio (HNR)
Ratio between noise and harmonic components of the sustained /a/ vowel phonation, expressed in decibels (dB).
Time frame
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Source ClinicalTrials.gov