Clinical trial NCT04995471: Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders Using the Rhythmic Reading Training (RRT)
Official title: Comparing the Effectiveness of Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders, Using a Rhythm-based Intervention for Reading (Rhythmic Reading Training, RRT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Dyslexia
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First posted: 2021-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effectiveness of telerehabilitation vs. in presence rehabilitation of reading disorders, using a rhythm-based intervention for reading (i.e., Rhythmic Reading Training)


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* presence of comorbidity with other neuropsychiatric or psychopathological conditions
* having been involved in previous reading intervention programs in the previous 3 months

Primary outcomes:
measure: Word reading - DDE-2
timeFrame: 5 weeks
measure: Word reading - DDE-2
timeFrame: 5 weeks
measure: Word reading - DDE-2
timeFrame: 3 months
measure: Word reading - DDE-2
timeFrame: 3 months
measure: Pseudo-word reading - DDE-2
timeFrame: 5 weeks
measure: Pseudo-word reading - DDE-2
timeFrame: 5 weeks
measure: Pseudo-word reading - DDE-2
timeFrame: 3 months
measure: Pseudo-word reading - DDE-2
timeFrame: 3 months
measure: Text reading - MT-3-Clinica Battery
timeFrame: 5 weeks
measure: Text reading - MT-3-Clinica Battery
timeFrame: 5 weeks
measure: Text reading - MT-3-Clinica Battery
timeFrame: 3 months
measure: Text reading - MT-3-Clinica Battery
timeFrame: 3 months
Secondary outcomes:
measure: Phonemic awareness task (Judica et al., in press)
timeFrame: 5 weeks
measure: Phonemic awareness task (Judica et al., in press)
timeFrame: 3 months
measure: Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
timeFrame: 5 weeks
measure: Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)
timeFrame: 3 months
measure: Rapid Automatized naming task - RAN (De Luca et al., 2005)
timeFrame: 5 weeks
measure: Rapid Automatized naming task - RAN (De Luca et al., 2005)
timeFrame: 3 months
measure: Rhythm reproduction task
timeFrame: 5 weeks
measure: Rhythm reproduction task
timeFrame: 3 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
References:
citation: Cancer A, Sarti D, De Salvatore M, Granocchio E, Chieffo DPR, Antonietti A. Dyslexia Telerehabilitation during the COVID-19 Pandemic: Results of a Rhythm-Based Intervention for Reading. Children (Basel). 2021 Nov 5;8(11):1011. doi: 10.3390/children8111011.