- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07718698
Effects of Tool Handling on Language Processing
Analysis of the Effect of a Tool-Handling Intervention in a Specific Context on the Linguistic Processing of Healthy Young Adults
This randomized controlled trial aims to investigate the effects of a context-specific tool-handling intervention on linguistic processing in healthy young adults. Participants will be allocated into three groups: a dexterous tool-use training group, a dexterous manual training group without tools, and a Control group.
The dexterous tool-use training group will perform a task-oriented activity involving the use of tweezers to place colored beads into a mandala within a specific functional context. The intervention requires sequential motor planning, force control, precision, and goal-directed tool use. The dexterous manual training group without tools will perform a similar bead-placement activity without tool use, involving direct hand manipulation and lower task complexity. Both intervention groups will participate in synchronous online sessions via Google Meet for 20 minutes per day, five times per week, over a two-week period.
The Control group will not receive any structured intervention and will instead be instructed to perform one activity of daily living using the non-dominant upper limb once per day during the two-week period.
Linguistic processing will be assessed through a sentence judgment task involving sentences with and without semantic violations, in which participants will classify the sentences as correct or incorrect while electroencephalographic activity (EEG) is recorded. Additionally, sleep quality and manual dexterity will also be evaluated.
The findings of this study may contribute to understanding the relationship between tool-related motor training and linguistic processing, particularly the interaction between motor and language systems in healthy young adults. Additionally, the study may provide evidence regarding neurophysiological changes associated with context-specific motor interventions.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Aline Pagnussat, PhD
- Номер телефона: +55 51 3303-8912
- Электронная почта: alinesp@ufcspa.edu.br
Места учебы
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Бразилия, 90050170
- UFCSPA
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Контакт:
- Thainara Cruz da Rosa, MsC
- Номер телефона: +55 51 991591680
- Электронная почта: thainaracruzr@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Healthy young adults aged between 19 and 24 years;
- Right-handed individuals.
Exclusion Criteria:
- Previous diagnosis of neurological and/or psychiatric disorders;
- History of traumatic brain injury;
- Use of psychoactive substances or medications that may affect cognitive functioning;
- Pregnancy or suspected pregnancy.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Контроль
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Participants allocated to the control group will not receive structured training.
They will be instructed to perform one activity of daily living using the non-dominant upper limb once per day during the two-week study period.
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Экспериментальный: Dexterous tool-use training
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The intervention will be supervised by a researcher through assynchronous way.
Participants will perform a task-oriented activity involving the use of tweezers to place colored beads into a mandala within a functional and goal-directed context.
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Активный компаратор: Dexterous manual training group without tools
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The intervention will be supervised by a researcher through assynchronous way.
Participants will perform a bead-placement activity directly with their hands, without the use of tools.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Assessment of Synthatic Processing Performance - Reaction time
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Linguistic processing will be evaluated through a computerized sentence judgment task composed of 60 sentences containing grammatical agreement violations and control sentences.
Reaction time will be measured as the time elapsed between the presentation of each sentence and the participant's button press indicating whether the sentence is grammatically correct or incorrect.
Mean reaction time across trials will be reported in milliseconds (ms).
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Assessment of Synthatic Processing Performance - Accuracy
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Linguistic processing will be evaluated through a computerized sentence judgment task composed of 60 sentences containing grammatical agreement violations and control sentences.
Accuracy will be assessed as the absolute number of correct responses.
The absolute number of incorrect responses (errors) will also be recorded.
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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N200 Event-Related Potential Mean Amplitude
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Event-related potentials (ERPs) will be recorded using electroencephalography (EEG) during a computerized linguistic judgment task involving sentences with and without gender and number agreement violations.
The mean amplitude of the N200 component will be measured within the predefined time window and electrodes of interest.
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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P300 Event-Related Potential Mean Amplitude
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Event-related potentials (ERPs) will be recorded using electroencephalography (EEG) during a computerized linguistic judgment task involving sentences with and without gender and number agreement violations.
The mean amplitude of the P300 component will be measured within the predefined time window and electrodes of interest.
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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N200 Event-Related Potential Peak Latency
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
|
Event-related potentials (ERPs) will be recorded using electroencephalography (EEG) during a computerized linguistic judgment task involving sentences with and without gender and number agreement violations.
The peak latency of the N200 component will be measured within the predefined time window and electrodes of interest.
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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P300 Event-Related Potential Peak latency
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
|
Event-related potentials (ERPs) will be recorded using electroencephalography (EEG) during a computerized linguistic judgment task involving sentences with and without gender and number agreement violations.
The peaky latency of the P300 component will be measured within the predefined time window and electrodes of interest.
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Assessment of Syntactic Production - Hierarchical Embedding in Spontaneous Discourse
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Syntactic production will be assessed through a spontaneous discourse task using the "Picnic Scene" from the Western Aphasia Battery (WAB).
Speech samples will be audio-recorded, transcribed, and analyzed using the NILC-Metrix platform.
Hierarchical embedding will be quantified as an index of syntactic complexity.
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Assessment of Syntactic Production - Clauses per Sentence in Spontaneous Discourse
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Syntactic production will be assessed through a spontaneous discourse task using the "Picnic Scene" from the Western Aphasia Battery (WAB).
Speech samples will be audio-recorded, transcribed, and analyzed using the NILC-Metrix platform.
Clauses per sentence will be calculated as a measure of syntactic complexity.
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Assessment of Syntactic Production - Left-Branching Load (Frazier Index) in Spontaneous Discourse
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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SSyntactic production will be assessed through a spontaneous discourse task using the "Picnic Scene" from the Western Aphasia Battery (WAB).
Speech samples will be audio-recorded, transcribed, and analyzed using the NILC-Metrix platform.
Left-branching load will be quantified using the Frazier Index.
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Manual dexterity
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Manual dexterity, visuomotor coordination, and executive functioning will be assessed using the Grooved Pegboard Test (GPT).
Participants will insert grooved pegs into a board as quickly as possible using both dominant and non-dominant hands.
Completion time (in seconds) will be recorded for each hand.
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Assessment of Sleep Quality
Временное ограничение: Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
The questionnaire evaluates subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Total scores range from 0 to 21, with scores above 5 indicating poor sleep quality.
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Change from PRE assessment (up to 1 week before intervention) to POST assessment (up to 1 week after intervention completion)
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- TOOLANG
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .