Music After Stroke To Enhance Rehabilitation (MASTER)
Primary Purpose
Stroke, Acute, Expressive Aphasia, Movement, Abnormal
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ipod with music
ipod with books to listen
ipod only with usual care
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of LMCA stroke within prior 24 hours
- Not identified as critically ill
- Glascow Coma Scale > 8 at time of consent
- Resident of a home with a land line or cell phone
- Able to speak in English or Spanish prior to stroke event
- Presence of expressive aphasia at time of enrollment.
Exclusion Criteria:
- Stroke diagnosis other than LMCA territory stroke
- Unable to provide consent by patient or legally accountable person acting on behalf of the patient (healthcare proxy, healthcare power of attorney), Patient/ representative
- Does not speak English or Spanish prior to stroke event
- Have a diagnosis of end stage cancer, or other medical conditions that dramatically increase a risk of mortality within one year
- Any pre-existing communication disorder (including dementia)
- Patients that are deemed critically ill will not be included
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Music
oral books
usual care
Arm Description
music supplied by ipod
Listening to books on ipod
Usual care
Outcomes
Primary Outcome Measures
expressive aphasia measured by use of the WAB-R
Change in expressive aphasia will be measured by use of the WAB-R. Western Aphasia Battery-Revised (WAB- R).This instrument is intended to provide a standardized measure of aphasia type and severity. Implementation of the instrument takes 15 approximately minutes to complete. THE WAB-R identifies and classifies 8 aphasia types: Global, Broca's, Isolation, Transcortical Motor, Wernicke's, transcortical Sensory, Conduction and Anomic. The WAB-R assesses linguistic skills more frequently affected by aphasia. Participants will be assessed at enrollment, discharge from hospital and again at 1,3,6 months post stroke.
motor activity right hand as measured using the Motor Activity log
Change in right hand motor activity and function will be assessed using the Motor Activity Log. The Motor Activity Log (MAL) is a semi-structured interview for hemiparetic stroke patients to assess the use of their paretic arm and hand Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting). Participants will be assessed at enrollment, discharge from hospital and again at 1,3,6 months post stroke.
Depressive symptoms as measured using the PHQ-9
A change in depressive symptoms will be assessed using the PHQ-9. The PHQ-9 will be used for screening for depression, as it has been identified as the preferred (gold standard) screening tool for depression among post stroke patients in hospitals. The PHQ-9 takes less than 5 minutes to administer, and has been shown to have superior sensitivity and specificity.
Quality of life as measured using the 20 item short form survey (SF-20)
Change quality of life is assessed in this study, a 20-item short form survey (SF-20) will be used to assess quality of life. Participants will be assessed at enrollment, discharge from hospital and again at 1,3,6 months post stroke.
Secondary Outcome Measures
Full Information
NCT ID
NCT04441515
First Posted
June 10, 2020
Last Updated
March 10, 2021
Sponsor
Pace University
Collaborators
Emory University
1. Study Identification
Unique Protocol Identification Number
NCT04441515
Brief Title
Music After Stroke To Enhance Rehabilitation
Acronym
MASTER
Official Title
Music After Stroke To Enhance Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2021 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pace University
Collaborators
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Music that is familiar and preferred by patients has been shown to heighten neuroplasticity and can mitigate these disabilities. Therefore, this study seeks to explore the effect of providing patient preferred music to patients in the very early post stroke period (within 24 hours of a left cerebral artery stroke [LMCA]event) as a complementary modality to usual stroke care.
Detailed Description
Aim I. The primary aim of MASTER is to identify whether a potential relationship exists between an intervention of participant preferred music, when initiated within the first 24 hours following a left middle cerebral artery stroke, and a reduction in the following disabilities: Expressive aphasia, right hand functional deficit and post stroke depression. This aim will serve to address the first research hypothesis and address the relationship between These disabilities are well known sequalae among patients diagnosed with the most common form of stroke, a LMCA stroke. Participant preferred music within the first 24 hours following a LMCA stroke and a reduction in: Expressive aphasia, right hand functional deficit and post stroke depression, as these disabilities are well known sequalae among LMCA stroke patients.
Aim II. The second aim of MASTER is to identify if a relationship exists between an intervention of audible books, when initiated within the first 24 hours following a LMCA stroke, and a reduction in the following disabilities: Expressive aphasia, right hand functional deficit and post stroke depression.
Sufficient evidence exists to suggest that although listening to books stimulates cognitive function, the effect of melody and participant engagement in music is far superior to listening to words alone as the inherent rhythmicity of patient-favored music has been shown to strengthen synchronous neuronal connectivity, by modulating dopamine and inducing fine grained neuroanatomical changes in a recovering brain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Expressive Aphasia, Movement, Abnormal, Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music
Arm Type
Experimental
Arm Description
music supplied by ipod
Arm Title
oral books
Arm Type
Active Comparator
Arm Description
Listening to books on ipod
Arm Title
usual care
Arm Type
Placebo Comparator
Arm Description
Usual care
Intervention Type
Device
Intervention Name(s)
Ipod with music
Intervention Description
music of patient's preference provided 2 hours daily
Intervention Type
Device
Intervention Name(s)
ipod with books to listen
Intervention Description
2 hours of daily listening to books
Intervention Type
Device
Intervention Name(s)
ipod only with usual care
Intervention Description
participants given device only
Primary Outcome Measure Information:
Title
expressive aphasia measured by use of the WAB-R
Description
Change in expressive aphasia will be measured by use of the WAB-R. Western Aphasia Battery-Revised (WAB- R).This instrument is intended to provide a standardized measure of aphasia type and severity. Implementation of the instrument takes 15 approximately minutes to complete. THE WAB-R identifies and classifies 8 aphasia types: Global, Broca's, Isolation, Transcortical Motor, Wernicke's, transcortical Sensory, Conduction and Anomic. The WAB-R assesses linguistic skills more frequently affected by aphasia. Participants will be assessed at enrollment, discharge from hospital and again at 1,3,6 months post stroke.
Time Frame
6 months
Title
motor activity right hand as measured using the Motor Activity log
Description
Change in right hand motor activity and function will be assessed using the Motor Activity Log. The Motor Activity Log (MAL) is a semi-structured interview for hemiparetic stroke patients to assess the use of their paretic arm and hand Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting). Participants will be assessed at enrollment, discharge from hospital and again at 1,3,6 months post stroke.
Time Frame
6 months
Title
Depressive symptoms as measured using the PHQ-9
Description
A change in depressive symptoms will be assessed using the PHQ-9. The PHQ-9 will be used for screening for depression, as it has been identified as the preferred (gold standard) screening tool for depression among post stroke patients in hospitals. The PHQ-9 takes less than 5 minutes to administer, and has been shown to have superior sensitivity and specificity.
Time Frame
6 months
Title
Quality of life as measured using the 20 item short form survey (SF-20)
Description
Change quality of life is assessed in this study, a 20-item short form survey (SF-20) will be used to assess quality of life. Participants will be assessed at enrollment, discharge from hospital and again at 1,3,6 months post stroke.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of LMCA stroke within prior 24 hours
Not identified as critically ill
Glascow Coma Scale > 8 at time of consent
Resident of a home with a land line or cell phone
Able to speak in English or Spanish prior to stroke event
Presence of expressive aphasia at time of enrollment.
Exclusion Criteria:
Stroke diagnosis other than LMCA territory stroke
Unable to provide consent by patient or legally accountable person acting on behalf of the patient (healthcare proxy, healthcare power of attorney), Patient/ representative
Does not speak English or Spanish prior to stroke event
Have a diagnosis of end stage cancer, or other medical conditions that dramatically increase a risk of mortality within one year
Any pre-existing communication disorder (including dementia)
Patients that are deemed critically ill will not be included
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Millie Hepburn, PhD
Phone
9147733367
Email
mhepburnsmith@pace.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lori Sutherly, MS
Phone
4192960978
Email
lori.j.sutherly@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Millie Hepburn, PhD
Organizational Affiliation
Pace University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Flanagan J. (1978). A research approach to improving our quality of life. American Psychologist, 33, 138-147.
Results Reference
background
Citation
Kertesz, A. (2006). Western Aphasia Battery-Revised. San Antonio, TX: Pearson.
Results Reference
background
PubMed Identifier
23613966
Citation
Amengual JL, Rojo N, Veciana de Las Heras M, Marco-Pallares J, Grau-Sanchez J, Schneider S, Vaquero L, Juncadella M, Montero J, Mohammadi B, Rubio F, Rueda N, Duarte E, Grau C, Altenmuller E, Munte TF, Rodriguez-Fornells A. Sensorimotor plasticity after music-supported therapy in chronic stroke patients revealed by transcranial magnetic stimulation. PLoS One. 2013 Apr 17;8(4):e61883. doi: 10.1371/journal.pone.0061883. Print 2013.
Results Reference
result
PubMed Identifier
10350414
Citation
Carver DJ, Chapman CA, Thomas VS, Stadnyk KJ, Rockwood K. Validity and reliability of the Medical Outcomes Study Short Form-20 questionnaire as a measure of quality of life in elderly people living at home. Age Ageing. 1999 Mar;28(2):169-74. doi: 10.1093/ageing/28.2.169.
Results Reference
result
PubMed Identifier
22215032
Citation
Edmonds LA, Donovan NJ. Item-level psychometrics and predictors of performance for Spanish/English bilingual speakers on an object and action naming battery. J Speech Lang Hear Res. 2012 Apr;55(2):359-81. doi: 10.1044/1092-4388(2011/10-0307). Epub 2012 Jan 3.
Results Reference
result
PubMed Identifier
28093560
Citation
Fox K, Stryker M. Integrating Hebbian and homeostatic plasticity: introduction. Philos Trans R Soc Lond B Biol Sci. 2017 Mar 5;372(1715):20160413. doi: 10.1098/rstb.2016.0413.
Results Reference
result
PubMed Identifier
11556941
Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
result
PubMed Identifier
29367334
Citation
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24. Erratum In: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:
Results Reference
result
PubMed Identifier
19158063
Citation
Kim M, Tomaino CM. Protocol evaluation for effective music therapy for persons with nonfluent aphasia. Top Stroke Rehabil. 2008 Nov-Dec;15(6):555-69. doi: 10.1310/tsr1506-555.
Results Reference
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PubMed Identifier
10568646
Citation
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
Results Reference
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PubMed Identifier
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Citation
Scholz DS, Rohde S, Nikmaram N, Bruckner HP, Grossbach M, Rollnik JD, Altenmuller EO. Sonification of Arm Movements in Stroke Rehabilitation - A Novel Approach in Neurologic Music Therapy. Front Neurol. 2016 Jun 30;7:106. doi: 10.3389/fneur.2016.00106. eCollection 2016.
Results Reference
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17030751
Citation
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Results Reference
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PubMed Identifier
15087552
Citation
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Results Reference
result
Learn more about this trial
Music After Stroke To Enhance Rehabilitation
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