Healthy ParticipantsNCT07232862
Analysis Of The Effect Of A Fine Manual Skills Intervention In A Specific Context On The Linguistic Processing of Healthy Young Adults
A study testing Context-Specific Fine Motor Skills Training and Fine Motor Skills Training in people with Healthy Participants, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Context-Specific Fine Motor Skills Training and Fine Motor Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- 13 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed young people between 19 and 24 years old;
- Accept participation in the study and sign the free and informed consent form.
Who cannot join
- Presence of previously diagnosed neurological and/or psychiatric disorders;
- History of traumatic brain injuries;
- Pregnant women or women suspected of being pregnant.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites, 2 recruiting
- Not yet recruiting
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
Aline Pagnussat, 555133038912, alinesp@ufcspa.edu.br
- Recruiting
UFCSPA
Porto Alegre, Rio Grande do Sul, 90050170
Aline Pagnussat, Professor, +555133038912, alinesp@ufcspa.edu.br
About this study
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
- Being tested
- Context-Specific Fine Motor Skills Training, Fine Motor Skills Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Context-Specific Fine Motor Skills TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Context-Specific Fine Motor Skills Training | Experimental | Not described Receives: Behavioral: Context-Specific Fine Motor Skills Training |
| Fine Motor Skills Training | Active comparator | Not described Receives: Behavioral: Fine Motor Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syntactic production
Participants described a pleasant autobiographical event and the "Picnic Scene" from the Western Aphasia Battery.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start13 Nov 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232862
- Sponsor's protocol ID
- Mandala
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis Of The Effect Of A Fine Manual Skills Intervention In A Specific Context On The Linguistic Processing of Healthy Young Adults
- ClinicalTrials.gov ID
- NCT07232862
- Acronym / sponsor ID
- Mandala
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Right-handed young people between 19 and 24 years old;
- Accept participation in the study and sign the free and informed consent form.
Key exclusion criteria (3 listed)
- Presence of previously diagnosed neurological and/or psychiatric disorders;
- History of traumatic brain injuries;
- Pregnant women or women suspected of being pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Context-Specific Fine Motor Skills TrainingThe 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. | Behavioural | Context-Specific Fine Motor Skills Training |
| Fine Motor Skills TrainingThe "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. | Behavioural | Fine Motor Skills Training |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Context-Specific Fine Motor Skills Training and Fine Motor Skills Training in people with Healthy Participants, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aline Pagnussat (555133038912, alinesp@ufcspa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.