- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02499133
Identification and Comprehension of Focused Stress in a Sentence Among Adults Who Suffered Traumatic Brain Injury
Researches that focus on the perception of prosodic elements among adult who suffered traumatic brain injury (TBI), focus on their ability to decipher intonation in order to understand an additional meaning of a sentence. According to these researches, adults who suffer from TBI, with no signs of Aphasia, have difficulty perceiving and deciphering intonation (Marquardt et al., 2001; Angeleri et al., 2008). The current research asks to broaden the knowledge in this domain by examining the ability of adults with TBI to understand an additional prosodic element - focused stress.
The ability to identify and understand focused stress in a sentence requires different abilities. First, a psychoacoustic ability in order to detect the stressed word. Second, an ability to understand the lexical grammatical meaning of the word as it negates other possible meanings (for example, in the sentence "I'm eating a red apple" the stressed word negated the option of a different color). Third, an understanding of the stressed word as it creates a different pragmatic/social meaning (for example, in the sentence "mom, I asked for red, yellow and green candy" the role of the stressed word is to mark the candy that the addressee didn't get).
The aim of the study is to assess the ability of adults who had experienced TBI to grasp and understand the meaning of focused stress in the different contexts that were described above. An additional aim is to examine if differences in speech and cognitive abilities can describe some of the variation in the results.
Thirty adults between the ages of 18-50 years will take part in this study, fifteen adults who had experienced moderate to severe TBI (0.5-3 years post injury) and fifteen healthy adults. Each participant with TBI will be matched to a healthy adult by gender, age, education and social-economic status. All of the participants will be Hebrew native speakers, with no learning disability, no neurological injury, proper speech abilities and no hearing impairment.
The participants will undergo seven different tests in three different meetings (60 minute each), in a quiet room at Sheba - Academic Medical Center Hospital. The tests will include different cognitive and language examinations. The main test of the study will be The Hebrew Focused Stress Test (HFST). The HFST includes three subtests. The first subtest requires identification of the stressed word in a sentence based on psychoacoustic abilities alone. The second and the third subtests require understanding the meaning of focused stress in different contexts - lexical grammatical and pragmatic/social. The test includes forty eight recorded sentences. In each sentence one word is stressed. The participants will be asked to listen to the recordings and answer a closed question regarding the stressed word.
Přehled studie
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ramat Gan, Izrael
- Nábor
- Sheba Medical Center
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Kontakt:
- Harold Weingarden, MD
- E-mail: Harold.Weingarden@sheba.health.gov.il
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Severity between moderate - severe as measured by the Glascow Coma Scale and time of PTA.
- Hebrew native speakers.
- between the ages of 18-50 years old.
- with no history of head trauma.
- with no history of use of addictive substance.
- with no history of psychiatric disorder.
- with no history of language disorder or language learning disability.
- with no degenerative cognition.
- are not suffering from aphasia.
- with a vision good enough to perform the tests of the study.
- with no hearing impairment.
- with a reading ability that is good enough to perform the test of the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Jiný: kontrolní skupina
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The participants will undergo seven different.
The tests will include different cognitive and language examinations.
The main test of the study will be The Hebrew Focused Stress Test (HFST).
The HFST includes three subtests.
The first subtest requires identification of the stressed word in a sentence based on psychoacoustic abilities alone.
The second and the third subtests require understanding the meaning of focused stress in different contexts - lexical grammatical and pragmatic/social.
The test includes forty eight recorded sentences.
In each sentence one word is stressed.
The participants will be asked to listen to the recordings and answer a closed question regarding the stressed word.
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Jiný: adult who suffered traumatic brain injury
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The participants will undergo seven different.
The tests will include different cognitive and language examinations.
The main test of the study will be The Hebrew Focused Stress Test (HFST).
The HFST includes three subtests.
The first subtest requires identification of the stressed word in a sentence based on psychoacoustic abilities alone.
The second and the third subtests require understanding the meaning of focused stress in different contexts - lexical grammatical and pragmatic/social.
The test includes forty eight recorded sentences.
In each sentence one word is stressed.
The participants will be asked to listen to the recordings and answer a closed question regarding the stressed word.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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The Hebrew Focused Stress Test (HFST)
Časové okno: 15 min
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The HFST includes three subtests.
The first subtest requires identification of the stressed word in a sentence based on psychoacoustic abilities alone.
The second and the third subtests require understanding the meaning of focused stress in different contexts - lexical grammatical and pragmatic/social.
The test includes forty eight recorded sentences.
In each sentence one word is stressed.
The participants will be asked to listen to the recordings and answer a closed question regarding the stressed word.
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15 min
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SHEBA-14-1031-HW-CTIL
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Klinické studie na Focused Stress
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VA Office of Research and DevelopmentVA St. Louis Health Care SystemUkončenoVeteráni podle St. Louis VAMC Stress TesSpojené státy