Learning DisordersNCT02797301
A Computerised Test for Assessing the Early Reading Skills
A study testing synthetic test and computerised test in people with Learning Disorders, run by University of Mogi das Cruzes.
Trial summary
This study was to develop a computerised test with an adapted peripheral to assess the emerging literacy knowledge of children with mobility difficulties. The software was implemented using a game-like design controllable by a peripheral device without needing fine movements. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Learning Disorders
- What is being tested?
- synthetic test and computerised test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 17 years
- Healthy volunteers accepted
- Child
Who may be able to join
- G1 and G2: preschool children; no motor difficulties and normal school performance.
- G3: with moderate mobility impairment; similar cognitive ages and notions of writing to the participants of groups G1 and G2; children between seven and seventeen years old.
Who cannot join
- G1 and G2: children who often miss classes; children between four and seven years.
- G3: no moderate mobility impairment
About this study
Official title: A Computerised Test for Assessing the Early Reading Skills of Children With Mobility Limitations
This study was to develop a computerised test with an adapted peripheral to assess the emerging literacy knowledge of children with mobility difficulties. The software was implemented using a game-like design controllable by a peripheral device without needing fine movements.
Read the detailed description
Conventional tests for assessing the early reading skills of preschool children on school entry are not accessible to children with mobility limitations. This paper presents a game-like computerised test featuring an appealing scenario that is accessible to these children. It was developed on a platform that creates 2D vector graphics and contains three phases of interactive content accessible through an adapted peripheral. Conventional tests were also used to validate the effectiveness of the game. The two types of tests had the same degree of predictive power when completed by thirty three preschool children without mobility impairment.
- Conditions
- Learning Disorders
- Being tested
- synthetic test, computerised test
- Keywords
- early reading skills
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synthetic testOther
The children performed the synthetic test with no time restriction.
computerised testOther
The children performed the computerised test with no time restriction.
| Study group | Role | What they receive |
|---|---|---|
| synthetic test & computerised test | Experimental | Seventeen preschool children (G1), with no motor impairments, from a private school. The children in G1 performed the synthetic test before the computerised test. Receives: Other: synthetic test; Other: computerised test |
| computerised test & synthetic test | Experimental | Sixteen preschool children (G2), with no motor impairments, from a private school. The children in G2 performed the computerised test before the synthetic test. Receives: Other: synthetic test; Other: computerised test |
| computerised test | Experimental | Seven volunteers (G3), two males and five females, with moderate mobility impairment, patients from the Physical Therapy and Rehabilitation Clinic. Receives: Other: computerised test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading skills
The tests determine whether children can differentiate between the letters of the alphabet and squiggles, numbers, and mathematical signs (first phase); can realise that the same word can be written using uppercase, lowercase, and cursive letters (second phase); know the correct number of letters required to graphically represent the sounds used in speech (third phase). The numbers of incorrect choices made by children during the three phases of the computerised test (G1, G2 and G3) and the synthetic test (G1 and G2) are quantified.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startSep 2010
- Primary completionSep 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Learning DisordersStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mogi das Cruzes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annie France Frère Slaets, University of Mogi das Cruzes
- Investigators
- Annie F. Frère, PhD, Principal investigator, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797301
- Sponsor's protocol ID
- 0135.0.237.000-10
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2016
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computerised Test for Assessing the Early Reading Skills of Children With Mobility Limitations
- ClinicalTrials.gov ID
- NCT02797301
- Acronym / sponsor ID
- 0135.0.237.000-10
- Conditions
- Learning Disorders
- Keywords
- early reading skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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 study was to develop a computerised test with an adapted peripheral to assess the emerging literacy knowledge of children with mobility difficulties. The software was implemented using a game-like design controllable by a peripheral device without needing fine movements.
Detailed description
Conventional tests for assessing the early reading skills of preschool children on school entry are not accessible to children with mobility limitations. This paper presents a game-like computerised test featuring an appealing scenario that is accessible to these children. It was developed on a platform that creates 2D vector graphics and contains three phases of interactive content accessible through an adapted peripheral. Conventional tests were also used to validate the effectiveness of the game. The two types of tests had the same degree of predictive power when completed by thirty three preschool children without mobility impairment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| synthetic test & computerised test | Experimental | Other: synthetic test, Other: computerised testSeventeen preschool children (G1), with no motor impairments, from a private school. The children in G1 performed the synthetic test before the computerised test. |
| computerised test & synthetic test | Experimental | Other: synthetic test, Other: computerised testSixteen preschool children (G2), with no motor impairments, from a private school. The children in G2 performed the computerised test before the synthetic test. |
| computerised test | Experimental | Other: computerised testSeven volunteers (G3), two males and five females, with moderate mobility impairment, patients from the Physical Therapy and Rehabilitation Clinic. |
Who may qualify
- Ages
- 4 to 17 years
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- G1 and G2: preschool children; no motor difficulties and normal school performance.
- G3: with moderate mobility impairment; similar cognitive ages and notions of writing to the participants of groups G1 and G2; children between seven and seventeen years old.
Key exclusion criteria (2 listed)
- G1 and G2: children who often miss classes; children between four and seven years.
- G3: no moderate mobility impairment
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 |
|---|---|---|
| synthetic testThe children performed the synthetic test with no time restriction. | Other | computerised test & synthetic test, synthetic test & computerised test |
| computerised testThe children performed the computerised test with no time restriction. | Other | computerised test, computerised test & synthetic test, synthetic test & computerised test |
Primary outcome
Reading skills
Time frame: 2 days
The tests determine whether children can differentiate between the letters of the alphabet and squiggles, numbers, and mathematical signs (first phase); can realise that the same word can be written using uppercase, lowercase, and cursive letters (second phase); know the correct number of letters required to graphically represent the sounds used in speech (third phase). The numbers of incorrect choices made by children during the three phases of the computerised test (G1, G2 and G3) and the synthetic test (G1 and G2) are quantified.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Annie F. Frère, PhD principal investigator
University of Mogi das Cruzes
Questions about this trial
What is this clinical trial studying?
A study testing synthetic test and computerised test in people with Learning Disorders, run by University of Mogi das Cruzes.
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 2 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: finished, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading skills (time frame: 2 days). 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 13 Jun 2016.