Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
Study NCT ID:
NCT01097161
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2010-03-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stuttering and Apraxia of Speech: the Efficacy of an Intervention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013342', 'term': 'Stuttering'}, {'id': 'D001072', 'term': 'Apraxias'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013070', 'term': 'Speech Therapy'}], 'ancestors': [{'id': 'D012049', 'term': 'Rehabilitation of Speech and Language Disorders'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-01', 'studyFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2010-03-31', 'lastUpdatePostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stuttering', 'Apraxia of speech', 'Motor control', 'Prosody', 'Pitch range', 'Speech rate', 'fluency disorders'], 'conditions': ['Stuttering', 'Developmental Apraxia of Speech']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.letras.ufmg.br/labfon', 'label': 'Laboratório de Fonética da FALE - UFMG'}, {'url': 'http://portal2.saude.gov.br/sisnep/pesquisador', 'label': 'Conselho nacional de Saúde'}, {'url': 'http://www.fapemig.br', 'label': 'Fundação de Amparo à pesquisa do Estado de Minas Gerais'}]}, 'descriptionModule': {'briefSummary': "Subjects' utterances were submitted to acoustic analysis before and after the intervention program applied on prosodic basis.", 'detailedDescription': 'The study has the aim of developing knowledge, methodology and technique in the prosody area, for its application on the speech therapy, with the assistance of a feedback system - with WinpitchPro (Philippe Martin). A database was constituted on the basis of a patterned corpus (EUROM1) by its translation, recording and editing on .wav format. Throughout model-sentences, an experimental intervention program initiates with the participation of 2 adults with stuttering problem and 2 with apraxia of speech. The efficacy of the therapeutic procedure is tested on the basis of the acoustical and the statistical analyses which have compared the first and the second speech samples taken before and after the twenty (20) therapy sessions held in a prosody approach only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of stuttering\n* Clinical diagnosis of apraxia of speech\n* 18 years of age or older\n* Portuguese native language\n* Agreement by the participant to enroll on 20 therapy sessions scheduled in a 3 month period\n\nExclusion Criteria:\n\n* History of major medical illness unrelated to primary diagnosis of developmental stuttering and developmental apraxia of speech\n* Significant abnormalities on general physical and neurological examination unrelated to primary diagnosis'}, 'identificationModule': {'nctId': 'NCT01097161', 'acronym': 'SAS:EIP', 'briefTitle': 'Stuttering and Apraxia of Speech: the Efficacy of an Intervention Program', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'The Speech Prosody of People With Stuttering and Developmental Apraxia: the Efficacy of an Intervention Program', 'orgStudyIdInfo': {'id': 'SHA 0097/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Speech treatment on prosodic basis', 'description': 'Patients receive 20 therapy sessions over a course of 3 months, with one double session per week.', 'interventionNames': ['Behavioral: speech therapy with the assistance of an acoustical analysis program']}], 'interventions': [{'name': 'speech therapy with the assistance of an acoustical analysis program', 'type': 'BEHAVIORAL', 'description': 'Two weekly speech sessions realized on individual basis for three months period', 'armGroupLabels': ['Speech treatment on prosodic basis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30150340', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'R. Grão Pará, 85/404', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do estado de Minas Gerais', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Bernadette von Atzingen Santos Cardoso', 'oldOrganization': 'Laboratório de Fonética -UFMG'}}}}