Back to resultsMusic and Adherence Home Programs Post Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Preferred music playlist
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Duquesne University Speech, Hearing, Language Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Preferred Music Playlist
Arm Description
All participants will have this phase twice in the protocol. See description in intervention section.
Outcomes
Primary Outcome Measures
Number of sessions of practice
Duration of sessions of practice
Number of minutes of practice
Secondary Outcome Measures
Canadian Occupational Performance Measure
Perceived occupational performance on activities of importance to the client
Motor Activity Log
Perceived amount and quality of use of the affected upper extremity
Western Aphasia Battery - Revised
Measure of language impairment
Cognitive Linguistic Quick Test
Measure of cognition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02906956
Brief Title
Music and Adherence Home Programs Post Stroke
Official Title
Music and Adherence in Upper Extremity Home Programs Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duquesne University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to explore whether adherence to upper extremity home programs changes when persons post stroke practice with preferred music.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preferred Music Playlist
Arm Type
Experimental
Arm Description
All participants will have this phase twice in the protocol. See description in intervention section.
Intervention Type
Behavioral
Intervention Name(s)
Preferred music playlist
Intervention 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.
Primary Outcome Measure Information:
Title
Number of sessions of practice
Time Frame
4 weeks
Title
Duration of sessions of practice
Time Frame
4 weeks
Title
Number of minutes of practice
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
Perceived occupational performance on activities of importance to the client
Time Frame
Baseline and no more than one week post intervention period
Title
Motor Activity Log
Description
Perceived amount and quality of use of the affected upper extremity
Time Frame
Baseline and no more than one week post intervention period
Title
Western Aphasia Battery - Revised
Description
Measure of language impairment
Time Frame
Baseline
Title
Cognitive Linguistic Quick Test
Description
Measure of cognition
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Qualitative Feedback Interview
Description
One-to-one interview with supported communication strategies on the experience of the intervention and study materials.
Time Frame
No more than 3 weeks post intervention period
Title
Intensity of Practice
Description
Rate of accelerations as measured by an activity monitor
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena V Donoso Brown, PhD
Organizational Affiliation
Duquesne University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duquesne University Speech, Hearing, Language Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15282
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Music and Adherence Home Programs Post Stroke
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