Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 9:30 PM
Study NCT ID:
NCT01163461
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2010-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001037', 'term': 'Aphasia'}], '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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'diane.kendall@va.gov', 'phone': '206-762-1010', 'title': 'Dr. Diane Kendall (PI)', 'organization': 'VAMC Puget Sound'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Single Group Open Trial', 'description': '28 individuals were randomized to receive either immediate speech therapy, or delayed speech therapy (following a 6 week delay period to control for Hawthorne effects). All participants received 60 hours of speech therapy 2 hours/day, 5 days/week for 6 weeks. Language behaviors were testing before, after and 3 months later.', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'No adverse events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Social circumstances'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Speech Production', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Aphasia Therapy', 'description': 'Single group, open trail where 28 individuals with aphasia received 60 hours of therapy'}], 'classes': [{'title': '% change immediately post treatment', 'categories': [{'measurements': [{'value': '5.27', 'spread': '8.09', 'groupId': 'OG000'}]}]}, {'title': '% change 3 months post treatment', 'categories': [{'measurements': [{'value': '5.28', 'spread': '7.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to one week post treatment termination and three months post treatment termination', 'description': 'percent change in the number of untrained words spoken correctly', 'unitOfMeasure': '% change score of untrained real words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Delayed Aphasia Therapy', 'description': '14 individuals were randomized to received aphasia therapy following a 6-week control delay phase. Upon completion of the 6-week control phase, they received 60 hours of behavioral therapy'}, {'id': 'FG001', 'title': 'Immediate Aphasia Therapy', 'description': '14 individuals were randomized to received 60 hours of aphasia therapy immediately following testing. (no delay)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral Aphasia Therapy', 'description': 'Single group, open trail where 28 individuals with aphasia received 60 hours of therapy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2014-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-30', 'studyFirstSubmitDate': '2010-07-14', 'resultsFirstSubmitDate': '2014-09-29', 'studyFirstSubmitQcDate': '2010-07-14', 'lastUpdatePostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-07-09', 'studyFirstPostDateStruct': {'date': '2010-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech Production', 'timeFrame': 'Baseline to one week post treatment termination and three months post treatment termination', 'description': 'percent change in the number of untrained words spoken correctly'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aphasia']}, 'referencesModule': {'references': [{'pmid': '23695900', 'type': 'RESULT', 'citation': 'Kendall DL, Hunting Pompon R, Brookshire CE, Minkina I, Bislick L. An analysis of aphasic naming errors as an indicator of improved linguistic processing following phonomotor treatment. Am J Speech Lang Pathol. 2013 May;22(2):S240-9. doi: 10.1044/1058-0360(2012/12-0078).'}]}, 'descriptionModule': {'briefSummary': "This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called 'aphasia'. Individuals who participate in this study will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).", 'detailedDescription': 'The study design was a single group (n=26) with repeated testing (3 times) pre- and post-treatment. All participants received the same treatment protocol (described in detail in Appendix A and in Minkina et al. (under review)). In order to control for improvement in language function related to passage of time, and for the effect of repeated exposure to outcome measures, individuals were randomly assigned to one of two conditions: delayed treatment or immediate treatment (Figure 2). Participants who were randomized to the delayed group received repeated testing three times before and three times after a six-week delay. During the delay phase they were permitted to participate in usual speech-language care (e.g., conversation groups and individual therapy).\n\nStandardized assessments and outcome measures (described in detail below) were administered prior to the start of treatment (for both immediate and delayed groups), at the end of the delay phase (delayed group only), immediately after treatment termination, and at three months post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* left hemisphere stroke\n* monolingual English speaking\n* right handed\n* presence of aphasia\n\nExclusion Criteria:\n\n* preexisting neurological condition'}, 'identificationModule': {'nctId': 'NCT01163461', 'briefTitle': 'Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Real Word Effects in Phonological Treatment for Word Retrieval', 'orgStudyIdInfo': {'id': 'C6572-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Treatment', 'description': 'individuals will receive 60 hours of speech therapy', 'interventionNames': ['Behavioral: speech therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed Treatment', 'description': 'individuals will receive 60 hours of speech therapy after 6 week delay period', 'interventionNames': ['Behavioral: speech therapy']}], 'interventions': [{'name': 'speech therapy', 'type': 'BEHAVIORAL', 'description': 'individuals will receive 60 hours of behavioral speech therapy', 'armGroupLabels': ['Delayed Treatment', 'Immediate Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Diane L. Kendall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Puget Sound Health Care System Seattle Division, Seattle, WA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}