NCT05636813

Brief Summary

Specific Written Language Disorders (SWLD) are severe and lasting impairments in the development of written language that affect approximately 10% of the school-age population.Concerned patients don't have any intellectual disability. Speech therapy help them to improve their language skills but also to compensate for their difficulties. School environment is one of the places where these disorders can constitute a real handicap. Given the prevalence of disorders, governments but also supra-governmental authorities have promoted educational integration of the concerned patients around the world. In France, different systems exist to help these patients with SWLD to follow an education that allows them to update their capacities as much as possible. School facilities are proposed such as attribution of Assistive Technology (AT). Nevertheless, these facilities have some limitations. Concerning AT, several studies have shown the benefits for patients with dyslexia such as a better use of them. However, there were some limitations in their use and their usefulness. The lack of use training is one of the barriers cited by patients and caregivers (parents and teachers). Assistive Technology training exists for patients with dyslexia but very few studies have measured their influence on their performance in written language. Moreover, these studies did not take into account the previous level of computer practice nor the natural appropriation of the AT (ie: anyone can appropriate themselves). It is therefore difficult to affirm the specificity of the training's influence. This study aims to assess the usefulness of AT training on the written language performance of adolescents with dyslexia. This work will study teenager's autonomy and how they use these tools.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 5, 2022

Status Verified

February 1, 2022

Enrollment Period

2.8 years

First QC Date

April 19, 2021

Last Update Submit

November 24, 2022

Conditions

Keywords

dyslexic adolescentdyslexiaeducationassistive technology

Outcome Measures

Primary Outcomes (32)

  • Reading skills without assistive technology before training: number of words read

    minimum 0 and maximum 152, higher scores mean a better outcome

    9 weeks

  • Reading skills without assistive technology before training: number of misread

    minimum 0 and maximum 152, higher scores mean a worse outcome

    9 weeks

  • Reading skills without assistive technology before training: time to read

    (in seconds, higher times mean a worse outcome)

    9 weeks

  • Reading comprehension skills without assistive technology before training: titles choices

    (higher scores mean a better outcome, minimum 0 and maximum 6)

    9 weeks

  • Reading comprehension skills without assistive technology before training: right or wrong

    (higher scores mean a better outcome: minimum 0 and maximum 8)

    9 weeks

  • Reading comprehension skills without assistive technology before training: choice of the good answer

    (higher scores mean a better outcome:minimum 0 and maximum 4).

    9 weeks

  • Reading effectiveness without assistive technology before training

    sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)

    9 weeks

  • Reading skills without assistive technology after training: number of words read

    (minimum 0 and maximum 152, higher scores mean a better outcome)

    9 weeks

  • Reading skills without assistive technology after training: number of misread

    (minimum 0 and maximum 152, higher scores mean a worse outcome)

    9 weeks

  • Reading skills without assistive technology after training: time to read

    (in seconds, higher times mean a worse outcome)

    9 weeks

  • Reading comprehension skills without assistive technology after training: titles choices

    (higher scores mean a better outcome, minimum 0 and maximum 6)

    9 weeks

  • Reading comprehension skills without assistive technology after training: right or wrong

    (higher scores mean a better outcome: minimum 0 and maximum 8)

    9 weeks

  • Reading comprehension skills without assistive technology after training: choice of the good answer

    (higher scores mean a better outcome:minimum 0 and maximum 4).

    9 weeks

  • Reading effectiveness without assistive technology after training

    sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)

    9 weeks

  • Reading skills with assistive technology before training: number of words read

    (minimum 0 and maximum 152, higher scores mean a better outcome)

    9 weeks

  • Reading skills with assistive technology before training: number of misread

    (minimum 0 and maximum 152, higher scores mean a worse outcome)

    9 weeks

  • Reading skills with assistive technology before training: time to read

    (in seconds, higher times mean a worse outcome)

    9 weeks

  • Reading comprehension skills with assistive technology before training: titles choices

    (higher scores mean a better outcome, minimum 0 and maximum 6)

    9 weeks

  • Reading comprehension skills with assistive technology before training: right or wrong

    (higher scores mean a better outcome: minimum 0 and maximum 8)

    9 weeks

  • Reading comprehension skills with assistive technology before training: choice of the good answer

    (higher scores mean a better outcome:minimum 0 and maximum 4).

    9 weeks

  • Reading effectiveness with assistive technology before training

    sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)

    9 weeks

  • Reading skills with assistive technology after training: number of words read

    (minimum 0 and maximum 152, higher scores mean a better outcome)

    9 weeks

  • Reading skills with assistive technology after training: number of misread

    (minimum 0 and maximum 152, higher scores mean a worse outcome)

    9 weeks

  • Reading skills with assistive technology after training: time to read

    (in seconds, higher times mean a worse outcome)

    9 weeks

  • Reading comprehension skills with assistive technology after training: titles choices

    (higher scores mean a better outcome, minimum 0 and maximum 6)

    9 weeks

  • Reading comprehension skills with assistive technology after training: right or wrong

    (higher scores mean a better outcome: minimum 0 and maximum 8)

    9 weeks

  • Reading comprehension skills with assistive technology after training: choice of the good answer

    (higher scores mean a better outcome:minimum 0 and maximum 4).

    9 weeks

  • Reading effectiveness with assistive technology after training

    sum (minimum 0 and maximum 172: higher scores mean a better outcome) of number of correct read words (minimum 0 and maximum 152) plus comprehension score (minimum 0 and maximum 18) plus reading score (0: failed, 1: partially succeded, 2 succeded)

    9 weeks

  • Written skills without assistive technology before training

    * Number of correct written words (handwriting) in 3 minutes (higher scores mean a better outcome) * Number of incorrect written words (handwriting) in 3 minutes (higher scores mean a worse outcome)

    9 weeks

  • Written skills without assistive technology after training

    * Number of correct written words (handwriting) in 3 minutes (higher scores mean a better outcome) * Number of incorrect written words (handwriting) in 3 minutes (higher scores mean a worse outcome)

    9 weeks

  • Written skills with assistive technology before training

    * Number of correct written words in 3 minutes (higher scores mean a better outcome) * Number of incorrect written words in 3 minutes (higher scores mean a worse outcome)

    9 weeks

  • Written skills with assistive technology after training

    * Number of correct written words in 3 minutes (higher scores mean a better outcome) * Number of incorrect written words in 3 minutes (higher scores mean a worse outcome)

    9 weeks

Secondary Outcomes (8)

  • Autonomy before training

    9 weeks

  • Autonomy after training

    9 weeks

  • Effectiveness of assistive technology utilization before training: Frequency of use

    9 weeks

  • Effectiveness of assistive technology utilization before training: Number of different utilization locations

    9 weeks

  • Effectiveness of assistive technology utilization before training: Number of different accomplished tasks

    9 weeks

  • +3 more secondary outcomes

Study Arms (1)

Training

EXPERIMENTAL

Program of training of use of assistive technology

Other: Training

Interventions

Patients are trained to use AT (2 sessions of 4 hours). Written langage skills, autonomy, the use are evaluated before and after training.

Training

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • adolescents with dyslexia
  • normal schooling (not in a specialized establishment)
  • with attribution of assistive technology less than 3 months or planned soon or low usage

You may not qualify if:

  • oral disabilities hindering intelligibility
  • physical disabilities (hands) hindering use of AT
  • auditive and visual disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Desmaisons

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hélène Desmaisons, MRS

    University Hospital of Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène Desmaisons, MRS

CONTACT

François Fournel, MR

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Pilot, pronostic, open-label, non-randomized, descriptive, study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

December 5, 2022

Study Start

March 8, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

December 5, 2022

Record last verified: 2022-02

Locations