NCT07232862

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Nov 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Nov 2025Dec 2026

First Submitted

Initial submission to the registry

September 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

September 12, 2025

Last Update Submit

April 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Syntactic production

    Participants described a pleasant autobiographical event and the "Picnic Scene" from the Western Aphasia Battery.

    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)

Secondary Outcomes (1)

  • Fine motor dexterity

    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)

Study Arms (2)

Context-Specific Fine Motor Skills Training

EXPERIMENTAL
Behavioral: Context-Specific Fine Motor Skills Training

Fine Motor Skills Training

ACTIVE COMPARATOR
Behavioral: Fine Motor Skills Training

Interventions

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.

Context-Specific 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.

Fine Motor Skills Training

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

NOT YET RECRUITING

UFCSPA

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

RECRUITING

Central Study Contacts

Aline Pagnussat

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2025

First Posted

November 18, 2025

Study Start

November 13, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations