Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-30 @ 1:03 PM
Study NCT ID:
NCT04471935
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Speech Hero Home Therapy for Aphasia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001039', 'term': 'Aphasia, Broca'}], 'ancestors': [{'id': 'D001037', 'term': 'Aphasia'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'irussell@flintrehab.com', 'phone': '3392232676', 'title': 'Ian Russell', 'organization': 'Flint Rehabilitation Devices'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'At Home Speech Hero Therapy', 'description': 'At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'At Home Speech Hero Therapy', 'description': 'At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for at least 10 hours over a 4-week period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately Post-Treatment, an average of 4 weeks', 'description': 'Number of participants able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues. Speech Hero will be deemed feasible for this population if at least 5 participants are able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Score on Western Aphasia Battery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'At Home Speech Hero Therapy', 'description': 'At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for at least 10 hours over a 4-week period.'}], 'classes': [{'title': 'Spontaneous Speech', 'categories': [{'measurements': [{'value': '3', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Auditory Verbal Comprehension', 'categories': [{'measurements': [{'value': '-1', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Repetition', 'categories': [{'measurements': [{'value': '2', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'Naming and Word Finding', 'categories': [{'measurements': [{'value': '6', 'spread': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Post-Treatment, an average of 4 weeks', 'description': 'Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. The Western Aphasia Battery (WAB) is comprised of 8 subscales. For this study the subscales of spontaneous speech, auditory verbal comprehension, repetition, naming and word finding were used. Results reported as change in score from baseline to post-treatment (each subscale score is on 0-100% scale with higher score representing less impairment).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Score on Boston Naming Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'At Home Speech Hero Therapy', 'description': 'At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for at least 10 hours over a 4-week period.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately Post-Treatment, an average of 4 weeks', 'description': 'Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cueing and after semantic cueing. Results reported as change in score from baseline to post-treatment (score for Boston Naming Test (BNT) is on 0-100% scale with higher score representing less impairment).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'At Home Speech Hero Therapy', 'description': 'At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Deemed ineligible to participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'At Home Speech Hero Therapy', 'description': 'At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '47', 'spread': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-12', 'size': 187274, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-12T18:37', 'hasProtocol': True}, {'date': '2021-12-15', 'size': 567822, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-12-15T14:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2020-07-07', 'resultsFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-12', 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks', 'timeFrame': 'Immediately Post-Treatment, an average of 4 weeks', 'description': 'Number of participants able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues. Speech Hero will be deemed feasible for this population if at least 5 participants are able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues.'}], 'secondaryOutcomes': [{'measure': 'Change in Score on Western Aphasia Battery', 'timeFrame': 'Immediately Post-Treatment, an average of 4 weeks', 'description': 'Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. The Western Aphasia Battery (WAB) is comprised of 8 subscales. For this study the subscales of spontaneous speech, auditory verbal comprehension, repetition, naming and word finding were used. Results reported as change in score from baseline to post-treatment (each subscale score is on 0-100% scale with higher score representing less impairment).'}, {'measure': 'Change in Score on Boston Naming Test', 'timeFrame': 'Immediately Post-Treatment, an average of 4 weeks', 'description': 'Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cueing and after semantic cueing. Results reported as change in score from baseline to post-treatment (score for Boston Naming Test (BNT) is on 0-100% scale with higher score representing less impairment).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Broca Aphasia']}, 'descriptionModule': {'briefSummary': "The investigators will run an at-home usability study of a newly developed speech therapy app called Speech Hero with 10 individuals with Broca's aphasia in the chronic stage of stroke. The Speech Hero app allows users to perform rhythm-based speech exercises at home. For this study participants will be instructed to use Speech Hero for at least 10 hours over a 4-week period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Broca's aphasia due to stroke,\n* \\>6 months post stroke\n* sufficient motor function of the unaffected upper extremity to tap on a table while speaking\n\nExclusion Criteria:\n\n* Incidence of other neurological diseases (though individuals with apraxia will be included)\n* age \\<85"}, 'identificationModule': {'nctId': 'NCT04471935', 'briefTitle': 'Speech Hero Home Therapy for Aphasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Flint Rehabilitation Devices, LLC'}, 'officialTitle': 'Speech Hero: a Rhythm-based Speech Therapy App for Individuals With Aphasia', 'orgStudyIdInfo': {'id': '1R43DC018771-01', 'link': 'https://reporter.nih.gov/quickSearch/1R43DC018771-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'At home Speech Hero therapy', 'interventionNames': ['Device: At home Speech Hero therapy app']}], 'interventions': [{'name': 'At home Speech Hero therapy app', 'type': 'DEVICE', 'description': 'Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 4-week period.', 'armGroupLabels': ['At home Speech Hero therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75080', 'city': 'Richardson', 'state': 'Texas', 'country': 'United States', 'facility': 'Callier Center at University of Texas Dallas', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}], 'overallOfficials': [{'name': 'Yune Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Flint Rehabilitation Devices, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Texas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}