- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07232862
Analysis Of The Effect Of A Fine Manual Skills Intervention In A Specific Context On The Linguistic Processing of Healthy Young Adults
April 8, 2026 updated by: Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aline Pagnussat
- Phone Number: 555133038912
- Email: alinesp@ufcspa.edu.br
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
- Not yet recruiting
- Federal University of Health Sciences of Porto Alegre
-
Contact:
- Aline Pagnussat
- Phone Number: 555133038912
- Email: alinesp@ufcspa.edu.br
-
Porto Alegre, Rio Grande do Sul, Brazil, 90050170
- Recruiting
- UFCSPA
-
Contact:
- Aline Pagnussat, Professor
- Phone Number: +555133038912
- Email: alinesp@ufcspa.edu.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Syntactic production
Time Frame: 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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fine motor dexterity
Time Frame: 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)
|
The fine motor dexterity will be evaluated through the Grooved Pegboard Test.
The test consists of picking a pine and putting it in the pegboard in a correct sequence.
The pegboard had 25 holes, and the score is measured in how much time the participant spends completing the pegboard.
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 13, 2025
Primary Completion (Actual)
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
September 12, 2025
First Submitted That Met QC Criteria
November 15, 2025
First Posted (Actual)
November 18, 2025
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Mandala
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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