NCT04995471

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
Last Updated

August 9, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

July 16, 2021

Last Update Submit

July 30, 2021

Conditions

Developmental Dyslexia

Outcome Measures

Primary Outcomes (12)

  • Word reading - DDE-2

    Word reading speed in syllable / seconds

    5 weeks

  • Word reading - DDE-2

    Word reading accuracy in n. of errors

    5 weeks

  • Word reading - DDE-2

    Word reading speed in syllable / seconds

    3 months

  • Word reading - DDE-2

    Word reading accuracy in n. of errors

    3 months

  • Pseudo-word reading - DDE-2

    Pseudo-word reading speed in syllable / seconds

    5 weeks

  • Pseudo-word reading - DDE-2

    Pseudo-word reading accuracy in n. of errors

    5 weeks

  • Pseudo-word reading - DDE-2

    Pseudo-word reading speed in syllable / seconds

    3 months

  • Pseudo-word reading - DDE-2

    Pseudo-word reading accuracy in n. of errors

    3 months

  • Text reading - MT-3-Clinica Battery

    Text reading speed in syllable / seconds

    5 weeks

  • Text reading - MT-3-Clinica Battery

    Text reading accuracy in n. of errors

    5 weeks

  • Text reading - MT-3-Clinica Battery

    Text reading speed in syllable / seconds

    3 months

  • Text reading - MT-3-Clinica Battery

    Text reading accuracy in n. of errors

    3 months

Secondary Outcomes (8)

  • Phonemic awareness task (Judica et al., in press)

    5 weeks

  • Phonemic awareness task (Judica et al., in press)

    3 months

  • Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)

    5 weeks

  • Digit span (Wechsler Intelligence Scale for Children-IV, WISC-IV)

    3 months

  • Rapid Automatized naming task - RAN (De Luca et al., 2005)

    5 weeks

  • +3 more secondary outcomes

Study Arms (5)

In presence RRT - prototype software

EXPERIMENTAL

10 biweekly in presence sessions of 45 minutes supervised by a trainer

Behavioral: In presence RRT - prototype software

In presence RRT - online platform

EXPERIMENTAL

10 biweekly in presence sessions of 45 minutes supervised by a trainer

Behavioral: In presence RRT - online platform

Tele-RRT - prototype software

EXPERIMENTAL

10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer

Behavioral: Tele-RRT - prototype software

Tele-RRT - online platform

EXPERIMENTAL

10 biweekly telerehabilitation sessions of 45 minutes supervised by a trainer

Behavioral: Tele-RRT - online platform

No intervention

NO INTERVENTION

5 weeks no intervention period

Interventions

In presence RRT - prototype softwareBEHAVIORAL

Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.

In presence RRT - prototype software
In presence RRT - online platformBEHAVIORAL

RRT is a web application with a client-server structure developed in javascript/php language using open-source support libraries. The server-side system uses a LAMP stack (Linux, Apache, Mysql, Php) on Server Cloud. The application can also be activated as a desktop application through "portable web server" installation systems, available for linux, windows and OS operating systems. In this form, the application can also be used in contexts without an Internet connection. The system is also accessible from tablets. RRT consists of a module of progressive reading exercises. The exercises are organized according to different types (syllables, words, non-words, short texts) and accompanied by a rhythmic-melodic stimulation, which is coordinated with a visual cue. Both remote (Rhythmic Reading Tele-Training, RRTT) and in presence administration (RRT) are available.

In presence RRT - online platform
Tele-RRT - prototype softwareBEHAVIORAL

Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.

Tele-RRT - prototype software
Tele-RRT - online platformBEHAVIORAL

RRT is a web application with a client-server structure developed in javascript/php language using open-source support libraries. The server-side system uses a LAMP stack (Linux, Apache, Mysql, Php) on Server Cloud. The application can also be activated as a desktop application through "portable web server" installation systems, available for linux, windows and OS operating systems. In this form, the application can also be used in contexts without an Internet connection. The system is also accessible from tablets. RRT consists of a module of progressive reading exercises. The exercises are organized according to different types (syllables, words, non-words, short texts) and accompanied by a rhythmic-melodic stimulation, which is coordinated with a visual cue. Both remote (Rhythmic Reading Tele-Training, RRTT) and in presence administration (RRT) are available.

Tele-RRT - online platform

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of the Sacred Heart

Milan, 20123, Italy

Location

Related Publications (1)

  • 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.

    PMID: 34828724DERIVED

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2021

First Posted

August 9, 2021

Study Start

April 15, 2020

Primary Completion

February 22, 2021

Study Completion

August 1, 2021

Last Updated

August 9, 2021

Record last verified: 2021-07

Locations

IT(1)