- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02906956
Music and Adherence Home Programs Post Stroke
July 12, 2019 updated by: Duquesne University
Music and Adherence in Upper Extremity Home Programs Post Stroke
The purpose of this study is to explore whether adherence to upper extremity home programs changes when persons post stroke practice with preferred music.
Study Overview
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15282
- Duquesne University Speech, Hearing, Language Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 40-85
- Mild to Moderate hemiparesis as determined by a score of 21 to 50 on the FM- UE
- At least 6 months post stroke
- American English as primary language
Exclusion Criteria:
- Significant visual impairment as determined by "aphasia-friendly" and age appropriate screening
- Significant hearing impairment as determined by self-report
- Actively receiving occupational or physical therapy services for upper extremity motor recovery
- 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
- Sitting or standing blood pressure of 180/110 or HE > 100 bpm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Preferred Music Playlist
All participants will have this phase twice in the protocol.
See description in intervention section.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of sessions of practice
Time Frame: 4 weeks
|
4 weeks
|
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Duration of sessions of practice
Time Frame: 4 weeks
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4 weeks
|
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Number of minutes of practice
Time Frame: 4 weeks
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Canadian Occupational Performance Measure
Time Frame: Baseline and no more than one week post intervention period
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Perceived occupational performance on activities of importance to the client
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Baseline and no more than one week post intervention period
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Motor Activity Log
Time Frame: Baseline and no more than one week post intervention period
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Perceived amount and quality of use of the affected upper extremity
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Baseline and no more than one week post intervention period
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Western Aphasia Battery - Revised
Time Frame: Baseline
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Measure of language impairment
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Baseline
|
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Cognitive Linguistic Quick Test
Time Frame: Baseline
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Measure of cognition
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Baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Qualitative Feedback Interview
Time Frame: No more than 3 weeks post intervention period
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One-to-one interview with supported communication strategies on the experience of the intervention and study materials.
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No more than 3 weeks post intervention period
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Intensity of Practice
Time Frame: 4 weeks
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Rate of accelerations as measured by an activity monitor
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elena V Donoso Brown, PhD, Duquesne University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
September 13, 2016
First Submitted That Met QC Criteria
September 19, 2016
First Posted (Estimate)
September 20, 2016
Study Record Updates
Last Update Posted (Actual)
July 16, 2019
Last Update Submitted That Met QC Criteria
July 12, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #2016/06/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.