Developmental DyslexiaNCT02791841
Comparison of Interventions for Developmental Dyslexia
A study testing Rhythmic Reading Training, Visual Hemispheric-Specific Stimulation + Action Video Games and Action Video Games in people with Developmental Dyslexia, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and that of an intervention resulting from the combination of two yet validated treatments for DD, namely… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Developmental Dyslexia
- What is being tested?
- Rhythmic Reading Training, Visual Hemispheric-Specific Stimulation + Action Video Games and Action Video Games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice
Who cannot join
- presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)
- having been involved in previous reading intervention programs
Trial locations and contacts
1 site in 1 country.
Alice Cancer, MD contact
Alessandro Antonietti, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Unit of Child Psychopathology, Scientific Institute IRCCS 'Eugenio Medea'
Bosisio Parini, 23842
Maria Luisa Lorusso, PhD, marialuisa.lorusso@bp.lnf.it
About this study
Official title: The Effectiveness of Intervention for Developmental Dyslexia: The Rhythmic Reading Training Compared With Hemisphere-Specific Stimulation and Action Video Games
The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and that of an intervention resulting from the combination of two yet validated treatments for DD, namely, Bakker's Visual Hemisphere-Specific Stimulation (VHSS) and the Action Video Game Training (AVG). Finally, the effectiveness of the administration of only AVG is intended to be compared to other treatments. All interventions are administered for 13 hours over 9 days to a group of Italian students with DD aged 8-12.
- Conditions
- Developmental Dyslexia
- Being tested
- Rhythmic Reading Training, Visual Hemispheric-Specific Stimulation + Action Video Games, Action Video Games
- Keywords
- Reading, Developmental Dyslexia,, Music, Rhythm, Action Video Games, Hemisphere-Specific Stimulation
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Reading TrainingBehavioural
Also called RRT
RRT is a child-friendly computerized reading training program designed for Italian students with DD aged 8-14 yrs. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed.
Visual Hemispheric-Specific Stimulation + Action Video GamesBehavioural
Also called VHSS+AVG
This training combines Visual Hemisphere-Specific Stimulation (VHSS) according to Bakker's Balance Model, and Action Video-Games (AVG). Hemispheric-specific stimulation is carried out by tachistoscopic presentation of words to a visual hemifield in order to selectively stimulate right-hemisphere perceptual analysis or left-hemisphere linguistic anticipation. A computerized program is used, in which the word is flashed and presented for less than 350 ms only if the child clicks on the mouse at the exact moment a dot is crossing a central target (control of eye position and fixation).
AVG training involves dyslexic participants in a video-game training, specifically aimed at improving visuo-spatial attentional abilities. A commercial WiiTM video game from UbisoftTM (suitable for children age 7 and older by the Pan European Game Information) called 'Rayman Raving Rabbids' is used.
Action Video GamesBehavioural
Also called AVG
AVG training involves dyslexic participants in a video-game training, specifically aimed at improving visuo-spatial attentional abilities. A commercial WiiTM video game from UbisoftTM (suitable for children age 7 and older by the Pan European Game Information) called 'Rayman Raving Rabbids' is used.
| Study group | Role | What they receive |
|---|---|---|
| RRT | Experimental | Rhythmic Reading Training, administered for 13 hours over 9 days (two 45-minute training sessions per day). Receives: Behavioral: Rhythmic Reading Training |
| VHSS+AVG | Experimental | Visual Hemispheric-Specific Stimulation + Action Video Games, administered for 13 hours over 9 days (two 45-minute training sessions per day). Receives: Behavioral: Visual Hemispheric-Specific Stimulation + Action Video Games |
| AVG | Experimental | Action Video Games only, administered for 13 hours over 9 days (two 45-minute training sessions per day). Receives: Behavioral: Action Video Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Text reading
The ability to read aloud a text was assessed using the Italian standardized test 'New MT reading tests for junior high school' (Nuove prove di lettura MT per la scuola media inferiore), which provides accuracy and speed scores in reading aloud age-normed texts.
Measured: 3 weeks
Word reading
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Measured: 3 weeks
Pseudo-word reading
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
Measured: 3 weeks
Secondary outcomes (5)
Lexical access
Rapid automatized naming ability was assessed using the 'Rapid Automatized Naming test (RAN) - Colours' test (Test di denominazione rapida - Colori); in this test, matrices of 5 different colours were presented. The colours were presented in small 1 by 1 cm squares; they were black, blue (RGB 51-102-255), red (RGB 221-8-6), yellow (RGB 252-243-5), or green (RGB 31-183-20). There were 10 rows of 5 stimuli in each matrix for a total of 50 stimuli. Two different matrices for each condition were provided. In the RAN test, the child was requested to name each stimulus in the matrix as quickly and as accurately as possible. The dependent measure was the mean time in seconds/syllable. Naming errors were also recorded.
Measured: 3 weeks
Phonological awareness: phonemic blending
Phoneme Blending assesses the capacity to derive a phonemic pattern from distinct phonemic units. The examiner presents each of 20 words, letter by letter, and the child is requested to mentally assemble them and report the resulting word. For both tasks, the scores refer to the total number of errors. Only age means (as raw scores) are provided.
Measured: 3 weeks
Phonological awareness: phonemic elision
Phonemic Elision assesses the ability to recognize and isolate the phonemic constituents of 20 words (in this specific case, the initial constituents). The child is asked to delete the first two phonemes in the word read by the examiner and to report the resulting pseudo-word.
Measured: 3 weeks
Auditory attention
Auditory selective attention was assessed using the Selective Auditory Attention Test from 'NEPSY-II'. In this task, the child listens to a pre-recorded list of words and touches the appropriate circle in the stimulus book when he or she hears a target word. This subtest has two parts. Auditory Attention is designed to assess selective auditory attention and the ability to sustain it (vigilance). Response Set is designed to assess the ability to shift and maintain a new and complex set involving both inhibition of previously learned responses and correctly responding to matching or contrasting stimuli. The child listens to a series of words and touches the appropriate circle when he or she hears a target word. Points are awarded only if the child responds correctly within 2 seconds of the target word presentation. Standard Scores are provided for the sum of Auditory Attention and Response Set.
Measured: 3 weeks
Rhythm perception and reproduction
Rhythm and sound length discrimination abilities were assessed using the Rhythm Task from the 'Q1 VATA Assessment Battery for Cross-domain Learning Abilities' (Batteria per la valutazione delle abilità trasversali all'apprendimento, Q1 VATA). Subtest 'Duration' proposes sequences of tones for which the child has to identify and indicate the tone differing from the others in duration (being shorter or longer than the other tones). There are 4-5 tones in a sequence. In the 'Rhythm' subtest, the child listens to sequences of 6 to 10 tones that can be either identical or different in the rhythmic pattern, and he has to decide whether the two sequences are the same or different. Rhythm reproduction ability was measured using the 'Rhythm reproduction task' test (Tre prove di ritmo), which consists of the request to reproduce a set of rhythmic patterns of increasing complexity. The child has to reproduce a sequence of beats (with the top of a pencil) as demonstrated by the examiner.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Eugenio Medea
- Responsible party
- Principal investigator, Alice Cancer, Catholic University of the Sacred Heart
- Investigators
- Alice Cancer, MD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791841
- Sponsor's protocol ID
- RRT-VHSS-AVG
- Status last verified
- Jan 2018
- First submitted
- 26 May 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Cancer A, Bonacina S, Antonietti A, Salandi A, Molteni M, Lorusso ML. The Effectiveness of Interventions for Developmental Dyslexia: Rhythmic Reading Training Compared With Hemisphere-Specific Stimulation and Action Video Games. Front Psychol. 2020 Jun 3;11:1158. doi: 10.3389/fpsyg.2020.01158. eCollection 2020.
PubMed 32581961
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Intervention for Developmental Dyslexia: The Rhythmic Reading Training Compared With Hemisphere-Specific Stimulation and Action Video Games
- ClinicalTrials.gov ID
- NCT02791841
- Acronym / sponsor ID
- RRT-VHSS-AVG
- Conditions
- Developmental Dyslexia
- Keywords
- Reading, Developmental Dyslexia,, Music, Rhythm, Action Video Games, Hemisphere-Specific Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- IRCCS Eugenio Medea
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Apr 2018 (estimated)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and that of an intervention resulting from the combination of two yet validated treatments for DD, namely, Bakker's Visual Hemisphere-Specific Stimulation (VHSS) and the Action Video Game Training (AVG). Finally, the effectiveness of the administration of only AVG is intended to be compared to other treatments. All interventions are administered for 13 hours over 9 days to a group of Italian students with DD aged 8-12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RRT | Experimental | Behavioral: Rhythmic Reading TrainingRhythmic Reading Training, administered for 13 hours over 9 days (two 45-minute training sessions per day). |
| VHSS+AVG | Experimental | Behavioral: Visual Hemispheric-Specific Stimulation + Action Video GamesVisual Hemispheric-Specific Stimulation + Action Video Games, administered for 13 hours over 9 days (two 45-minute training sessions per day). |
| AVG | Experimental | Behavioral: Action Video GamesAction Video Games only, administered for 13 hours over 9 days (two 45-minute training sessions per day). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice
Key exclusion criteria (2 listed)
- presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)
- having been involved in previous reading intervention programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic Reading TrainingAlso: RRTRRT is a child-friendly computerized reading training program designed for Italian students with DD aged 8-14 yrs. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed. | Behavioural | RRT |
| Visual Hemispheric-Specific Stimulation + Action Video GamesAlso: VHSS+AVGThis training combines Visual Hemisphere-Specific Stimulation (VHSS) according to Bakker's Balance Model, and Action Video-Games (AVG). Hemispheric-specific stimulation is carried out by tachistoscopic presentation of words to a visual hemifield in order to selectively stimulate right-hemisphere perceptual analysis or left-hemisphere linguistic anticipation. A computerized program is used, in which the word is flashed and presented for less than 350 ms only if the child clicks on the mouse at the exact moment a dot is crossing a central target (control of eye position and fixation). AVG training involves dyslexic participants in a video-game training, specifically aimed at improving visuo-spatial attentional abilities. A commercial WiiTM video game from UbisoftTM (suitable for children age 7 and older by the Pan European Game Information) called 'Rayman Raving Rabbids' is used. | Behavioural | VHSS+AVG |
| Action Video GamesAlso: AVGAVG training involves dyslexic participants in a video-game training, specifically aimed at improving visuo-spatial attentional abilities. A commercial WiiTM video game from UbisoftTM (suitable for children age 7 and older by the Pan European Game Information) called 'Rayman Raving Rabbids' is used. | Behavioural | AVG |
Primary outcome
Text reading
Time frame: 3 weeks
The ability to read aloud a text was assessed using the Italian standardized test 'New MT reading tests for junior high school' (Nuove prove di lettura MT per la scuola media inferiore), which provides accuracy and speed scores in reading aloud age-normed texts.
Word reading
Time frame: 3 weeks
The ability to read aloud lists of words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for word reading (4 lists of 28 words each with different lengths and frequency of use); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for word reading (4 lists of 30 words varying according to length: short vs. long and frequency of use: low vs. high frequency).
Pseudo-word reading
Time frame: 3 weeks
The ability to read aloud lists of pseudo-words was assessed using the following Italian standardized tests: 'Assessment battery for Developmental Dyslexia and Dysorthography-2' (Batteria per la valutazione della dislessia e disortografia evolutiva - DDE-2), in which speed and accuracy scores were computed for pseudo-word reading (2 lists of 16 pseudo-words each with different lengths); 'Word and pseudo-word reading test' (WPRT, Prova di lettura di parole e non parole), in which speed and accuracy scores were computed for pseudo-words reading (2 lists of 30 pseudo-words varying for length: short vs. long).
5 secondary outcomes
Lexical access
Time frame: 3 weeks
Phonological awareness: phonemic blending
Time frame: 3 weeks
Phonological awareness: phonemic elision
Time frame: 3 weeks
Auditory attention
Time frame: 3 weeks
Rhythm perception and reproduction
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Derived from this study: PubMed 32581961Cancer A, Bonacina S, Antonietti A, Salandi A, Molteni M, Lorusso ML. The Effectiveness of Interventions for Developmental Dyslexia: Rhythmic Reading Training Compared With Hemisphere-Specific Stimulation and Action Video Games. Front Psychol. 2020 Jun 3;11:1158. doi: 10.3389/fpsyg.2020.01158. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Cancer, MD contact
Alessandro Antonietti, PhD contact
Alice Cancer, MD principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Reading Training, Visual Hemispheric-Specific Stimulation + Action Video Games and Action Video Games in people with Developmental Dyslexia, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Cancer, MD (alice.cancer@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Text reading (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02791841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.