- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05636813
Usefulness of an Assistive Technology Training Program for Adolscents With Dyslexia (FormONC)
Usefulness of an Assistive Technology Training Program for Adolescents With Dyslexia: Pilot Study
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hélène Desmaisons, MRS
- Phone Number: +33231065905
- Email: desmaisons-h@chu-caen.fr
Study Contact Backup
- Name: François Fournel, Mr
- Phone Number: +33231065781
- Email: fournel-f@chu-caen.fr
Study Locations
-
-
-
Caen, France, 14000
- Recruiting
- Desmaisons
-
Contact:
- François Fournel, Mr
- Phone Number: +33231065781
- Email: fournel-f@chu-caen.fr
-
Contact:
- Hélène Desmaisons, MRS
- Phone Number: +3321065905
- Email: desmaisons-h@chu-caen.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- oral disabilities hindering intelligibility
- physical disabilities (hands) hindering use of AT
- auditive and visual disabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training
Program of training of use of assistive technology
|
Patients are trained to use AT (2 sessions of 4 hours).
Written langage skills, autonomy, the use are evaluated before and after training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reading skills without assistive technology before training: number of words read
Time Frame: 9 weeks
|
minimum 0 and maximum 152, higher scores mean a better outcome
|
9 weeks
|
Reading skills without assistive technology before training: number of misread
Time Frame: 9 weeks
|
minimum 0 and maximum 152, higher scores mean a worse outcome
|
9 weeks
|
Reading skills without assistive technology before training: time to read
Time Frame: 9 weeks
|
(in seconds, higher times mean a worse outcome)
|
9 weeks
|
Reading comprehension skills without assistive technology before training: titles choices
Time Frame: 9 weeks
|
(higher scores mean a better outcome, minimum 0 and maximum 6)
|
9 weeks
|
Reading comprehension skills without assistive technology before training: right or wrong
Time Frame: 9 weeks
|
(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
Time Frame: 9 weeks
|
(higher scores mean a better outcome:minimum 0 and maximum 4).
|
9 weeks
|
Reading effectiveness without assistive technology before training
Time Frame: 9 weeks
|
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
Time Frame: 9 weeks
|
(minimum 0 and maximum 152, higher scores mean a better outcome)
|
9 weeks
|
Reading skills without assistive technology after training: number of misread
Time Frame: 9 weeks
|
(minimum 0 and maximum 152, higher scores mean a worse outcome)
|
9 weeks
|
Reading skills without assistive technology after training: time to read
Time Frame: 9 weeks
|
(in seconds, higher times mean a worse outcome)
|
9 weeks
|
Reading comprehension skills without assistive technology after training: titles choices
Time Frame: 9 weeks
|
(higher scores mean a better outcome, minimum 0 and maximum 6)
|
9 weeks
|
Reading comprehension skills without assistive technology after training: right or wrong
Time Frame: 9 weeks
|
(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
Time Frame: 9 weeks
|
(higher scores mean a better outcome:minimum 0 and maximum 4).
|
9 weeks
|
Reading effectiveness without assistive technology after training
Time Frame: 9 weeks
|
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
Time Frame: 9 weeks
|
(minimum 0 and maximum 152, higher scores mean a better outcome)
|
9 weeks
|
Reading skills with assistive technology before training: number of misread
Time Frame: 9 weeks
|
(minimum 0 and maximum 152, higher scores mean a worse outcome)
|
9 weeks
|
Reading skills with assistive technology before training: time to read
Time Frame: 9 weeks
|
(in seconds, higher times mean a worse outcome)
|
9 weeks
|
Reading comprehension skills with assistive technology before training: titles choices
Time Frame: 9 weeks
|
(higher scores mean a better outcome, minimum 0 and maximum 6)
|
9 weeks
|
Reading comprehension skills with assistive technology before training: right or wrong
Time Frame: 9 weeks
|
(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
Time Frame: 9 weeks
|
(higher scores mean a better outcome:minimum 0 and maximum 4).
|
9 weeks
|
Reading effectiveness with assistive technology before training
Time Frame: 9 weeks
|
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
Time Frame: 9 weeks
|
(minimum 0 and maximum 152, higher scores mean a better outcome)
|
9 weeks
|
Reading skills with assistive technology after training: number of misread
Time Frame: 9 weeks
|
(minimum 0 and maximum 152, higher scores mean a worse outcome)
|
9 weeks
|
Reading skills with assistive technology after training: time to read
Time Frame: 9 weeks
|
(in seconds, higher times mean a worse outcome)
|
9 weeks
|
Reading comprehension skills with assistive technology after training: titles choices
Time Frame: 9 weeks
|
(higher scores mean a better outcome, minimum 0 and maximum 6)
|
9 weeks
|
Reading comprehension skills with assistive technology after training: right or wrong
Time Frame: 9 weeks
|
(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
Time Frame: 9 weeks
|
(higher scores mean a better outcome:minimum 0 and maximum 4).
|
9 weeks
|
Reading effectiveness with assistive technology after training
Time Frame: 9 weeks
|
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
Time Frame: 9 weeks
|
|
9 weeks
|
Written skills without assistive technology after training
Time Frame: 9 weeks
|
|
9 weeks
|
Written skills with assistive technology before training
Time Frame: 9 weeks
|
|
9 weeks
|
Written skills with assistive technology after training
Time Frame: 9 weeks
|
|
9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autonomy before training
Time Frame: 9 weeks
|
Autonomy in the daily life (number of help's need) (higher scores mean a worse outcome)
|
9 weeks
|
Autonomy after training
Time Frame: 9 weeks
|
Autonomy in the daily life (number of help's need) (higher scores mean a worse outcome)
|
9 weeks
|
Effectiveness of assistive technology utilization before training: Frequency of use
Time Frame: 9 weeks
|
(minutes per week) (higher scores mean a better outcome)
|
9 weeks
|
Effectiveness of assistive technology utilization before training: Number of different utilization locations
Time Frame: 9 weeks
|
(home, school, …) (higher scores mean a better outcome)
|
9 weeks
|
Effectiveness of assistive technology utilization before training: Number of different accomplished tasks
Time Frame: 9 weeks
|
(games, homework, messaging, social networks, …) (higher scores mean a better outcome)
|
9 weeks
|
Effectiveness of assistive technology utilization after training: Frequency of use
Time Frame: 9 weeks
|
(minutes per week) (higher scores mean a better outcome)
|
9 weeks
|
Effectiveness of assistive technology utilization after training: Number of different utilization locations
Time Frame: 9 weeks
|
(home, school, …) (higher scores mean a better outcome)
|
9 weeks
|
Effectiveness of assistive technology utilization after training: Number of different accomplished tasks
Time Frame: 9 weeks
|
(games, homework, messaging, social networks, …) (higher scores mean a better outcome)
|
9 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hélène Desmaisons, MRS, University Hospital of Caen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-160
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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