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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05636813
Other study ID # 20-160
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 8, 2021
Est. completion date December 31, 2024

Study information

Verified date February 2022
Source University Hospital, Caen
Contact Hélène Desmaisons, MRS
Phone +33231065905
Email desmaisons-h@chu-caen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 8 Years to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Desmaisons Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reading skills without assistive technology before training: number of words read minimum 0 and maximum 152, higher scores mean a better outcome 9 weeks
Primary Reading skills without assistive technology before training: number of misread minimum 0 and maximum 152, higher scores mean a worse outcome 9 weeks
Primary Reading skills without assistive technology before training: time to read (in seconds, higher times mean a worse outcome) 9 weeks
Primary Reading comprehension skills without assistive technology before training: titles choices (higher scores mean a better outcome, minimum 0 and maximum 6) 9 weeks
Primary Reading comprehension skills without assistive technology before training: right or wrong (higher scores mean a better outcome: minimum 0 and maximum 8) 9 weeks
Primary 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
Primary 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
Primary Reading skills without assistive technology after training: number of words read (minimum 0 and maximum 152, higher scores mean a better outcome) 9 weeks
Primary Reading skills without assistive technology after training: number of misread (minimum 0 and maximum 152, higher scores mean a worse outcome) 9 weeks
Primary Reading skills without assistive technology after training: time to read (in seconds, higher times mean a worse outcome) 9 weeks
Primary Reading comprehension skills without assistive technology after training: titles choices (higher scores mean a better outcome, minimum 0 and maximum 6) 9 weeks
Primary Reading comprehension skills without assistive technology after training: right or wrong (higher scores mean a better outcome: minimum 0 and maximum 8) 9 weeks
Primary 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
Primary 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
Primary Reading skills with assistive technology before training: number of words read (minimum 0 and maximum 152, higher scores mean a better outcome) 9 weeks
Primary Reading skills with assistive technology before training: number of misread (minimum 0 and maximum 152, higher scores mean a worse outcome) 9 weeks
Primary Reading skills with assistive technology before training: time to read (in seconds, higher times mean a worse outcome) 9 weeks
Primary Reading comprehension skills with assistive technology before training: titles choices (higher scores mean a better outcome, minimum 0 and maximum 6) 9 weeks
Primary Reading comprehension skills with assistive technology before training: right or wrong (higher scores mean a better outcome: minimum 0 and maximum 8) 9 weeks
Primary 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
Primary 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
Primary Reading skills with assistive technology after training: number of words read (minimum 0 and maximum 152, higher scores mean a better outcome) 9 weeks
Primary Reading skills with assistive technology after training: number of misread (minimum 0 and maximum 152, higher scores mean a worse outcome) 9 weeks
Primary Reading skills with assistive technology after training: time to read (in seconds, higher times mean a worse outcome) 9 weeks
Primary Reading comprehension skills with assistive technology after training: titles choices (higher scores mean a better outcome, minimum 0 and maximum 6) 9 weeks
Primary Reading comprehension skills with assistive technology after training: right or wrong (higher scores mean a better outcome: minimum 0 and maximum 8) 9 weeks
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Autonomy before training Autonomy in the daily life (number of help's need) (higher scores mean a worse outcome) 9 weeks
Secondary Autonomy after training Autonomy in the daily life (number of help's need) (higher scores mean a worse outcome) 9 weeks
Secondary Effectiveness of assistive technology utilization before training: Frequency of use (minutes per week) (higher scores mean a better outcome) 9 weeks
Secondary Effectiveness of assistive technology utilization before training: Number of different utilization locations (home, school, …) (higher scores mean a better outcome) 9 weeks
Secondary Effectiveness of assistive technology utilization before training: Number of different accomplished tasks (games, homework, messaging, social networks, …) (higher scores mean a better outcome) 9 weeks
Secondary Effectiveness of assistive technology utilization after training: Frequency of use (minutes per week) (higher scores mean a better outcome) 9 weeks
Secondary Effectiveness of assistive technology utilization after training: Number of different utilization locations (home, school, …) (higher scores mean a better outcome) 9 weeks
Secondary Effectiveness of assistive technology utilization after training: Number of different accomplished tasks (games, homework, messaging, social networks, …) (higher scores mean a better outcome) 9 weeks
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