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- Sperimentazione clinica NCT02916524
Previsione dei risultati della riabilitazione nell'afasia bilingue utilizzando la modellazione computazionale (PROCoM)
Studio randomizzato in doppio cieco che indaga l'uso della modellazione computazionale per prevedere i risultati della riabilitazione nell'afasia bilingue
The purpose of this investigation is to implement a computational model that can predict and optimize training and cross-language generalization patterns for bilingual persons with aphasia (BPA). The proposed work will determine the best possible treatment program for each individual patient even before they are rehabilitated. In addition, the computational model allows specification of variables such as age of acquisition, language exposure/proficiency, impairment and their systematic influence on a range of language rehabilitation outcomes.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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California
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San Francisco, California, Stati Uniti, 94132
- San Francisco State University
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Boston University Sargent College
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Texas
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Austin, Texas, Stati Uniti, 78757
- Austin Speech Labs
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Any number of years of education
- Bilingual: speaking both Spanish and English (or Chinese and English) with any degree of language proficiency prior to stroke
- Aphasia secondary to a left-hemisphere stroke (diagnosed by a neurologist on the basis of clinical CT/MRI imaging or medical reports)
- Aphasia resulting from stroke or dementia
- Naming deficits must be present with concurrent lexical/semantic impairment
- Visual and auditory acuity sufficient for all assessment and treatment procedures
- Ability to understand study and follow study procedures for the entire length of the study
Exclusion Criteria:
- Premorbid history of speech/language disorder
- Proficient in more than just Spanish and English (or Chinese and English)
- Overt, behaviorally noticeable, attentional limitations that interfere with completing the experimental tasks
- Active medical disease that may compromise participation (e.g., cancer undergoing acute treatment, unstable diabetes, renal or hepatic insufficiency, fluctuating systemic immunological disease such as systemic lupus erythematosis, etc.)
- Currently taking medications that are known to exert significant effects on cognitive processes, such as neuroleptics, steroids, anticholinesterase inhibitors, etc.
- Current drug or alcohol use or dependence that would interfere with adherence to study requirements, in the opinion of the principal investigator
- Inability or unwillingness of individual to give written informed consent
- Diagnosed with mental illness other than active depression
- Neurological condition other than that which resulted in aphasia
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Model-based
Semantic Feature Analysis training will be provided in the language that was selected by the computational model. |
SFA training entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, action associated with item). Treatment is applied to a set of items in the context of single-subject, multiple baseline designs so that replication of treatment effects could be evaluated within and across participants. Treatment will be administered two times per week until prescribed accuracy levels were met during treatment probes or a maximum number of treatment sessions was completed. |
|
Comparatore attivo: Model-opposite
Semantic Feature Analysis training will be provided in the language opposite to that which was selected by the computational model. |
SFA training entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, action associated with item). Treatment is applied to a set of items in the context of single-subject, multiple baseline designs so that replication of treatment effects could be evaluated within and across participants. Treatment will be administered two times per week until prescribed accuracy levels were met during treatment probes or a maximum number of treatment sessions was completed. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Word Retrieval Accuracy in English and Spanish
Lasso di tempo: Through study completion, an average of 10 weeks
|
Accuracy of naming black and white pictures that are both trained and untrained in English and Spanish will be assessed in naming tests. These tests were conducted repeatedly throughout the study, from baseline (prior to treatment) to the end of treatment. All naming responses were scored using as correct or incorrect. Proportion accuracy was calculated for each set of items for every testing session. Baseline scores were compared to end of treatment scores to obtain individual effect sizes for each sets of items for each participant. |
Through study completion, an average of 10 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Psycholinguistic Assessments of Language Processing in Aphasia (PALPA) in Both Languages
Lasso di tempo: Baseline, post-treatment (on average 10 weeks)
|
The PALPA/Evaluación del Procesamiento Lingüístico en la Afasia (EPLA) is a standardized assessment for reading simple words and spoken words in both English and Spanish out of 30 words. |
Baseline, post-treatment (on average 10 weeks)
|
|
Boston Naming Test (BNT) in Both Languages
Lasso di tempo: Baseline, post-treatment (on average 10 weeks)
|
The BNT is a standardized naming assessment that includes 60 pictures that can be named in either English or Spanish. |
Baseline, post-treatment (on average 10 weeks)
|
|
Western Aphasia Battery (WAB-R) in Both Languages
Lasso di tempo: Baseline, post-treatment (on average 10 weeks)
|
Western Aphasia Battery:The WAB-R is a standardized, gold-standard assessment for determining the presence, type, and severity of post-stroke aphasia, with excellent reliability and validity. The WAB-R measures performance across a variety of expressive and receptive language domains and takes approximately 45-60 minutes to administer. Weighted performance across four of these domains - spontaneous speech, auditory verbal comprehension, repetition, and naming/word finding - yields a composite score, the WAB-R Aphasia Quotient (AQ). The WAB-R AQ is an impairment-based metric that reliably indexes aphasia severity across different aphasia subtypes. Range is 0 t0 100. |
Baseline, post-treatment (on average 10 weeks)
|
|
Pyramids and Palm Trees Test (PAPT) 3 Pictures Version
Lasso di tempo: Baseline, post-treatment (on average 10 weeks)
|
The Pyramids and Palm Trees is a non-verbal (language-independent) semantic processing assessment that includes 3 pictures of which the person has to decide which two go together. There are 52 items in this test with a range of 1-52. |
Baseline, post-treatment (on average 10 weeks)
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Swathi Kiran, PhD, Boston University
Pubblicazioni e link utili
Pubblicazioni generali
- Penaloza C, Dekhtyar M, Scimeca M, Carpenter E, Mukadam N, Kiran S. Predicting treatment outcomes for bilinguals with aphasia using computational modeling: Study protocol for the PROCoM randomised controlled trial. BMJ Open. 2020 Nov 18;10(11):e040495. doi: 10.1136/bmjopen-2020-040495.
- Russell-Meill M, Carpenter E, Marte MJ, Scimeca M, Penaloza C, Kiran S. Measurement of cross-language and cross-domain generalization following semantic feature-based anomia treatment in bilingual aphasia. Neuropsychol Rehabil. 2026 Apr;36(3):544-570. doi: 10.1080/09602011.2025.2522196. Epub 2025 Jun 26.
Collegamenti utili
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stimato)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 4492E
- U01DC014922-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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