Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-04-24 @ 1:58 AM
Study NCT ID:
NCT02906956
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2016-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music and Adherence Home Programs Post Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2016-09-13', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Qualitative Feedback Interview', 'timeFrame': 'No more than 3 weeks post intervention period', 'description': 'One-to-one interview with supported communication strategies on the experience of the intervention and study materials.'}, {'measure': 'Intensity of Practice', 'timeFrame': '4 weeks', 'description': 'Rate of accelerations as measured by an activity monitor'}], 'primaryOutcomes': [{'measure': 'Number of sessions of practice', 'timeFrame': '4 weeks'}, {'measure': 'Duration of sessions of practice', 'timeFrame': '4 weeks'}, {'measure': 'Number of minutes of practice', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Canadian Occupational Performance Measure', 'timeFrame': 'Baseline and no more than one week post intervention period', 'description': 'Perceived occupational performance on activities of importance to the client'}, {'measure': 'Motor Activity Log', 'timeFrame': 'Baseline and no more than one week post intervention period', 'description': 'Perceived amount and quality of use of the affected upper extremity'}, {'measure': 'Western Aphasia Battery - Revised', 'timeFrame': 'Baseline', 'description': 'Measure of language impairment'}, {'measure': 'Cognitive Linguistic Quick Test', 'timeFrame': 'Baseline', 'description': 'Measure of cognition'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore whether adherence to upper extremity home programs changes when persons post stroke practice with preferred music.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 40-85\n* Mild to Moderate hemiparesis as determined by a score of 21 to 50 on the FM- UE\n* At least 6 months post stroke\n* American English as primary language\n\nExclusion Criteria:\n\n* Significant visual impairment as determined by "aphasia-friendly" and age appropriate screening\n* Significant hearing impairment as determined by self-report\n* Actively receiving occupational or physical therapy services for upper extremity motor recovery\n* Severe auditory comprehension impairment such that they cannot understand one-step directions as indicated by a WAB-R score below 8/10 on Sequential Commands Subtest\n* Sitting or standing blood pressure of 180/110 or HE \\> 100 bpm'}, 'identificationModule': {'nctId': 'NCT02906956', 'briefTitle': 'Music and Adherence Home Programs Post Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Duquesne University'}, 'officialTitle': 'Music and Adherence in Upper Extremity Home Programs Post Stroke', 'orgStudyIdInfo': {'id': '#2016/06/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preferred Music Playlist', 'description': 'All participants will have this phase twice in the protocol. See description in intervention section.', 'interventionNames': ['Behavioral: Preferred music playlist']}], 'interventions': [{'name': 'Preferred music playlist', 'type': 'BEHAVIORAL', 'description': 'Client will be instructed in a home program based on repetitive task practice principles and will complete this program with and without the use of a preferred music playlist during practice.', 'armGroupLabels': ['Preferred Music Playlist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15282', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duquesne University Speech, Hearing, Language Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Elena V Donoso Brown, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duquesne University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duquesne University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}