University of Salamanca
Salamanca, 34007, Spain
Location status: Recruiting
NCT Number: NCT07435155
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Salamanca, 34007, Spain
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Diagnosed with acquired brain injury (ABI), including:
Exclusion criteria
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)
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.
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.
Time frame: Baseline
Median fundamental frequency (F0) of sustained /a/ vowel phonation, expressed in Hertz (Hz).
Time frame: Baseline
Short-term frequency perturbation of sustained /a/ vowel phonation, expressed as a percentage (%).
Time frame: Baseline
Short-term amplitude perturbation of sustained /a/ vowel phonation, expressed as a percentage (%).
Time frame: Baseline
Ratio between noise and harmonic components of the sustained /a/ vowel phonation, expressed in decibels (dB).
Time frame: Baseline
Maximum duration of sustained vowel phonation (/a/) measured during a standardized task, expressed in seconds (s).
Time frame: Baseline
Maximum duration of sustained fricative emission measured during a standardized task, expressed in seconds (s).
Time frame: Baseline
Ratio between maximum sustained durations of voiceless (/s/) and voiced (/z/) fricative emissions, expressed as a dimensionless ratio.
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).
Time frame: Baseline
Forced vital capacity measured by standard spirometry during a forced expiratory manoeuvre, expressed in litres (L).
Time frame: Baseline
Forced expiratory volume in the first second measured by standard spirometry, expressed in litres (L).
Time frame: Baseline
Maximum voluntary ventilation measured by standard spirometry during rapid and deep breathing, expressed in litres per minute (L/min).
Time frame: Baseline
Ratio between forced expiratory volume in one second and forced vital capacity, expressed as a percentage (%).
Contact information is provided by the study sponsor or research team.
AHMED ARGOUBI, Speech Language Pathologist
CONTACT
Ana-María Martín-Nogueras, Investigator/ Profesor
CONTACT
University of Salamanca
Other
Evaluating Dysarthria Through Acoustic and Respiratory Parameters: A Clinical Protocol
Acronym: ACURES
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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