Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT03199092
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2017-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rhythmic Reading Training Compared to 'Abilmente' Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004410', 'term': 'Dyslexia'}], 'ancestors': [{'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Text reading accuracy expressed in number of errors change', 'timeFrame': '1 month', 'description': "Text reading accuracy expressed in number of errors The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts."}, {'measure': 'Text reading speed expressed in syllables per seconds change', 'timeFrame': '1 month', 'description': "The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts."}, {'measure': 'Word reading speed expressed in syllables per seconds change', 'timeFrame': '1 month', 'description': "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)."}, {'measure': 'Word reading accuracy expressed in number of errors change', 'timeFrame': '1 month', 'description': "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)."}, {'measure': 'Pseudo-word reading speed expressed in syllables per seconds change', 'timeFrame': '1 month', 'description': "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)."}, {'measure': 'Pseudo-word reading accuracy expressed in number of errors change', 'timeFrame': '1 month', 'description': "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)."}, {'measure': 'Text reading accuracy expressed in number of errors change', 'timeFrame': '2.5 months', 'description': "Text reading accuracy expressed in number of errors The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts."}, {'measure': 'Text reading speed expressed in syllables per seconds change', 'timeFrame': '2.5 months', 'description': "The ability to read aloud a text was assessed using the Italian standardized test 'Prove di lettura MT', which provides speed and accuracy scores in reading aloud age-normed texts."}, {'measure': 'Word reading speed expressed in syllables per seconds change', 'timeFrame': '2.5 months', 'description': "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)."}, {'measure': 'Word reading accuracy expressed in number of errors change', 'timeFrame': '2.5 months', 'description': "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)."}, {'measure': 'Pseudo-word reading speed expressed in syllables per seconds change', 'timeFrame': '2.5 months', 'description': "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)."}, {'measure': 'Pseudo-word reading accuracy expressed in number of errors change', 'timeFrame': '2.5 months', 'description': "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)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reading', 'Developmental Dyslexia', 'Music', 'Rhythm', 'Intervention'], 'conditions': ['Developmental Dyslexia']}, 'descriptionModule': {'briefSummary': "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 a multimodal intervention comprising different methodology, called 'Abilmente'. All interventions were delivered for a period ranging 1-2,5 months, in 60 minutes biweekly sessions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)\n* exclusion criteria for the use of tDCS (e.g. epilepsy, pregnancy).'}, 'identificationModule': {'nctId': 'NCT03199092', 'briefTitle': "Rhythmic Reading Training Compared to 'Abilmente' Method", 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': "Effectiveness of Intervention for Developmental Dyslexia: Rhythmic Reading Training Compared to 'Abilmente' Method", 'orgStudyIdInfo': {'id': 'RRT-Abilmente'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RRT+sat', 'description': 'RRT in combination with specific auditory training (sat) administered for a total of 20 hours over 10 weeks (60 minutes biweekly sessions).', 'interventionNames': ['Behavioral: RRT+sat']}, {'type': 'EXPERIMENTAL', 'label': 'Abilmente', 'description': 'Abilmente method administered for a total of 10 hours over 5 weeks (60 minutes biweekly sessions).', 'interventionNames': ['Behavioral: Abilmente']}], 'interventions': [{'name': 'RRT+sat', 'type': 'BEHAVIORAL', 'description': '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. For this study, RRT was delivered in combination with a specific auditory training involving several music games specifically designed for improving auditory processing abilities typically compromised in children with DD.', 'armGroupLabels': ['RRT+sat']}, {'name': 'Abilmente', 'type': 'BEHAVIORAL', 'description': "'Abilmente' method is an intervention for DD that comprises several validated treatments resulting in a proposal tailored to meet individual needs and features.", 'armGroupLabels': ['Abilmente']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20123', 'city': 'Milan', 'country': 'Italy', 'facility': 'Catholic University of the Sacred Heart', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Studio Abilmente', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Alessandro Antonietti, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Catholic University of the Sacred Heart'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD candidate', 'investigatorFullName': 'Alice Cancer', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}