Prismatic adaptation for the treatment of dyslexia
| ISRCTN | ISRCTN15190285 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15190285 |
- Submission date
- 20/10/2023
- Registration date
- 21/11/2023
- Last edited
- 29/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Developmental dyslexia (DD) is a neurodevelopmental disorder characterized by poor reading acquisition, despite adequate intelligence and sensory-motor skills. DD occurs in 5–10% of the population and may limit academic and professional achievement. Current treatment options for dyslexia show modest effectiveness, are often time-consuming, and are scarcely appealing to children and adolescents. The aim of this study is to evaluate a rehabilitation technique, prismatic adaptation (PA), as a new treatment for DD.
Who can participate?
Adolescents aged 13-17 years diagnosed with DD at the specialty learning disability clinic of Sapienza University of Rome, Italy.
What does the study involve?
Participants will be randomly assigned to one of two groups, intervention or waitlist. All participants in the waitlist group will be informed at baseline that they will be offered the intervention at follow-up, i.e., after 10 weeks.
The intervention group participates in sessions of PA combined with a digital intervention for the training of memory and attention by means of the MindLenses (TM) device. PA is a non-invasive technique that consists in wearing special goggles with prismatic lenses while pointing to a target. This enables a recalibration of visual attention after a few minutes of pointing. Treatment sessions will be held once weekly for 10 consecutive weeks and last about 30 minutes. At the end of the treatment period and at 6, and 10 months after treatment end, participants will be revaluated by our research team to assess treatment benefits.
What are the possible benefits and risks of participating?
There are no potential harms known from the use of PA although potential tiredness due to treatment length (once-weekly sessions over 10 consecutive weeks) cannot be excluded.
Where is the study run from?
Sapienza University of Rome (Italy)
When is the study starting and how long is it expected to run for?
December 2021 to October 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Lauro Quadrana, lauro.quadrana@uniroma1.it
Contact information
Public, Scientific
via dei Sabelli 108
Lazio
00185
Italy
| Phone | +39 (0)6 49972969 |
|---|---|
| giulia.conte@uniroma1.it |
Principal Investigator
via dei Sabelli 108
Rome
00185
Italy
| Phone | +39 (0)6 499 72969 |
|---|---|
| lauro.quadrana@uniroma1.it |
Public, Scientific
Department of Biomedicine, Neurosciences and Advanced Diagnostics (BiND)
University of Palermo
Via del Vespro
Palermo
90127
Italy
| Phone | +39 (0)91 23865700 |
|---|---|
| massimiliano.oliveri@unipa.it |
Study information
| Study design | Interventional non-pharmacological randomized controlled with cross-over phase |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Prismatic adaptation coupled with cognitive training: a novel non-phonological treatment for developmental dyslexia |
| Study acronym | PA for dyslexia |
| Study objectives | Prismatic adaptation combined with cognitive training improves reading abilities in adolescents with developmental dyslexia |
| Ethics approval(s) | Approved 24/01/2024, Comitato Etico Lazio Area 1 (Viale del Policlinico 155, Rome, 00161, Italy; +39 (0)3280057979; giulia.conte@uniroma1.it), ref: 0195/2024 |
| Health condition(s) or problem(s) studied | Developmental dyslexia |
| Intervention | Prismatic adaptation, i.e., a visuomotor adaptation technique, combined with cognitive training will be delivered by means of the MindLenses (TM) device to study participants in order to evaluate the efficacy of treatment for dyslexia remediation. Recruited participants will be randomly assigned to one of two groups, intervention or waitlist. All participants assigned to the intervention arm will receive 10 sessions of PA combined with tablet-delivered cognitive training delivered once weekly. All participants in the waitlist group will be informed at baseline that they will be offered the intervention at follow-up, i.e., after 10 weeks. Two follow-up tests will be performed after treatment at 6 months and at 12 months, to provide information on the duration of treatment effects over time. The researchers used a stratified randomization method to control and balance the influence of covariates. Sex (two levels: male, female) and age (two levels: 13.0-14.9 years, 15.0-16.9 years) were used to achieve balance among groups in terms of participants' baseline characteristics (covariates). With these two covariates, possible block combinations total four (e.g., female in the 13.0-14.9 age range). A simple randomization procedure, such as flipping a coin, is used to assign the participants within each block to one of the two treatment groups. |
| Intervention type | Other |
| Primary outcome measure | 1. Reading speed, assessed in syllables per second and calculated using this formula (syllables read correctly/seconds) by reading out loud the text included in the MT-Avanzate-3 battery or the in the MT-16-19 battery. Assessed at baseline, 10 weeks after treatment start, 6 months after treatment end, 12 months after treatment end. 2. Reading accuracy, expressed as percentage value (%) of correct words and pseudowords read out loud from the DDE-2 battery. Assessed at baseline, 10 weeks after treatment start, 6 months after treatment end, 12 months after treatment end. |
| Secondary outcome measures | 1. Working memory index, assessed as quotient (mean=100, 1 SD=15) provided by the Wechsler Intelligence Scale for Children - Fourth Edition. Assessed at baseline, 10 weeks after treatment start, 6 months after treatment end, 12 months after treatment end. 2. Processing speed index, assessed as quotient (mean=100, 1 SD=15) provided by the Wechsler Intelligence Scale for Children - Fourth Edition. Assessed at baseline, 10 weeks after treatment start, 6 months after treatment end, 12 months after treatment end. |
| Overall study start date | 01/12/2021 |
| Completion date | 01/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 13 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Diagnosis of developmental dyslexia 2. Total IQ above the low average range (≥80), as confirmed on the Wechsler intelligence scale for children – fourth edition (WISC-IV) 3. Either Working Memory Index (WMI) or Processing Speed Index (PSI) below the low average range (80), or both |
| Key exclusion criteria | 1. Presence of other neurodevelopmental disorders, particularly attention-deficit/hyperactivity disorder (ADHD) 2. Any major comorbid psychiatric disorder such as schizophrenia, bipolar disorder, or major depression disorder a diagnosis of active epilepsy 3. Physical disabilities that could impair the use of the study instruments |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 01/06/2024 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rome
00185
Italy
Sponsor information
Hospital/treatment centre
viale del Policlinico 155
Rome
00185
Italy
| Phone | +39 (0)649971 |
|---|---|
| lauro.quadrana@uniroma1.it | |
| Website | http://www.policlinicoumberto1.it/ |
"ROR" |
https://ror.org/011cabk38 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets created and analysed for the current study will be made available upon request from Dr Lauro Quadrana (lauro.quadrana@uniroma1.it). The type of data that will be shared: anonymous aggregate (group) data of the investigated outcome measures. Dates of availability: after publication in a scientific journal. Whether consent from participants was required and obtained: consent was required and obtained to participate in the study, which also implied the possibility of sharing participants’ anonymized data for research publication and purposes only. Comments on data anonymization: all data will be available upon reasonable request in aggregate form and completely anonymized. |
Editorial Notes
29/02/2024: Ethics approval details added.
17/11/2023: Trial's existence confirmed by Comitato Etico Lazio Area 1
