Analysis Of The Effect Of A Fine Manual Skills Intervention In A Specific Context On The Linguistic Processing of Healthy Young Adults

Обзор

This is a randomized, single-blind clinical trial that will include healthy individuals between the ages of 19 and 24. Participants with previously diagnosed neurological and/or psychiatric disorders, a history of traumatic brain injury, use of psychoactive substances or medications that may affect cognition, and pregnant women or women suspected of being pregnant will be excluded. The sample will be a convenience sample, with participants randomly allocated to intervention and control groups (1:1), and the sample size calculation will be based on a pilot study. Participants will be assessed at two different time points, before and after the intervention, for fine manual dexterity and syntactic language processing. The intervention group will undergo fine manual dexterity training in a specific context, while the control group will undergo an intervention with a less complex task and without a specific context. Both protocols will consist of 20-minute sessions, held five times a week over two weeks, in a synchronous online format, via the Google Meet videoconferencing platform.

Вмешательства

• Поведенческое Context-Specific Fine Motor Skills Training
  The intervention for the "Context-Specific Fine Motor Skills Training" group will consist of practicing fine manual dexterity in a task-oriented context, characterized by clear and functional objectives. The activity will begin with solving mathematical calculations, the results of which will range from 1 to 4, each associated with a specific color of bead. Using tweezers, the participant must select the bead corresponding to the result obtained, apply glue, and fill the indicated space of the m
• Поведенческое Fine Motor Skills Training
  The "Fine Motor Skills Training" group will undergo an intervention with a less complex task. Participants will complete the mandala using only their hands to manipulate the beads. The duration and frequency protocol will be identical to that of the experimental group, with 20-minute sessions, five times a week, over two weeks.

Первичные конечные точки

• Syntactic production [Срок оценки: Baseline (2 to 3 days before the beginning of intervention) and post-intervention (2 weeks after the beginning of intervention, and 1 day after the last day of intervention)]

Вторичные конечные точки (1)

• Fine motor dexterity [Срок оценки: Baseline (2 to 3 days before the beginning of intervention) and post-intervention (2 weeks after the beginning of intervention, and 1 day after the last day of intervention)]

Критерии участия

Критерии включения

• Right-handed young people between 19 and 24 years old;
• Accept participation in the study and sign the free and informed consent form.

Критерии исключения

• Presence of previously diagnosed neurological and/or psychiatric disorders;
• History of traumatic brain injuries;
• Pregnant women or women suspected of being pregnant.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 2 центра

• Federal University of Health Sciences of Porto Alegre — Porto Alegre
• UFCSPA — Porto Alegre

Идентификаторы

NCT: NCT07232862 · Mandala

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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