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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02791841
Other study ID # RRT-VHSS-AVG
Secondary ID
Status Recruiting
Phase N/A
First received May 26, 2016
Last updated January 23, 2018
Start date January 2016
Est. completion date April 2018

Study information

Verified date January 2018
Source Catholic University of the Sacred Heart
Contact Alice Cancer, MD
Email alice.cancer@unicatt.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
Italy Unit of Child Psychopathology, Scientific Institute IRCCS 'Eugenio Medea' Bosisio Parini

Sponsors (2)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 weeks
Primary 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). 3 weeks
Primary 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). 3 weeks
Secondary 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. 3 weeks
Secondary 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. 3 weeks
Secondary 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. 3 weeks
Secondary 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. 3 weeks
Secondary 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. 3 weeks
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