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

NCT ID: NCT07232862

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-13
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Context-Specific Fine Motor Skills Training

Group Type: EXPERIMENTAL

Context-Specific Fine Motor Skills Training

Intervention Type: BEHAVIORAL

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 mandala. The intervention will be carried out for 20 minutes per day, five times a week, over the course of two weeks.

Fine Motor Skills Training

Group Type: ACTIVE_COMPARATOR

Fine Motor Skills Training

Intervention Type: BEHAVIORAL

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.

Interventions

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 mandala. The intervention will be carried out for 20 minutes per day, five times a week, over the course of two weeks.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Aline de Souza Pagnussat

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: NOT_YET_RECRUITING

UFCSPA

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Aline Pagnussat

Role: CONTACT

alinesp@ufcspa.edu.br

555133038912

Facility Contacts

Aline Pagnussat

Role: primary

alinesp@ufcspa.edu.br

555133038912

Aline Pagnussat, Professor

Role: primary

alinesp@ufcspa.edu.br

+555133038912

Other Identifiers

Mandala

Identifier Type: -

Identifier Source: org_study_id