Graphomotor Intervention Program for Handwriting Difficulties Prevention in School-Age (NCT03699800) | Clinical Trial Compass
CompletedNot Applicable
Graphomotor Intervention Program for Handwriting Difficulties Prevention in School-Age
Portugal47 participantsStarted 2018-10-15
Plain-language summary
12-30% of children present handwriting difficulties, which has negative repercussions on their school career. For this reason, it is fundamental to bet on their prevention. The aim of present study is to examine the effects of a graphomotor intervention program on quality and speed of handwriting in second-grade children. This experimental study is a randomized controlled trial. The program will run for 8 weeks (2 sessions/week of 30 minutes), followed by 6 months of follow-up without intervention. Participants will be assessed 1) at baseline, 2) at the end of the program, and 3) after the follow-up. Participants will be randomly allocated to two groups: experimental group (graphomotor intervention program) and control group.
Who can participate
Age range
7 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children in the second grade (aged 7 years old);
* Participation agreement;
Exclusion Criteria:
* Diagnosed or suspected of neurological disabilities (e.g., cerebral palsy, epilepsy), psychiatric and/or behavioural disorders;
* Presence of uncorrected vision and hearing problems;
* Referenced by Special Education/National Service of Early Intervention in Childhood;
* Presence of one or more school retentions;
* Native language is not Portuguese;
* Children with direct intervention in graphomotor skills or who had a similar intervention to that proposed less than 1 year ago;
* Participation in the intervention program of less than 80%;
* Children undergoing drug therapy (e.g., antihistamines) that interfere with the study variables;
* Do not wish to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline, between and within groups comparison, in Motor Performance
Timeframe: 0, 4, 10 months
2
Change from Baseline, between and within groups comparison, in handwriting performance
Timeframe: 0, 4, 10 months
3
Change from Baseline, between and within groups comparison, in Computerized Handwriting Process Measures