NCT02797301

Brief 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.

Trial Health

100
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
Completed

Started Sep 2010

Status
completed

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 Start

First participant enrolled

September 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

Same day

First QC Date

June 2, 2016

Last Update Submit

June 7, 2016

Conditions

Keywords

early reading skills

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 days

Study Arms (3)

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.

Other: synthetic testOther: 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.

Other: synthetic testOther: 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.

Other: computerised test

Interventions

The children performed the synthetic test with no time restriction.

computerised test & synthetic testsynthetic test & computerised test

The children performed the computerised test with no time restriction.

computerised testcomputerised test & synthetic testsynthetic test & computerised test

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • G1 and G2: children who often miss classes; children between four and seven years.
  • G3: no moderate mobility impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Annie F. Frère, PhD

    University of Mogi das Cruzes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 13, 2016

Study Start

September 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2011

Last Updated

June 13, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share