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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
Pace University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 10, 2020
    Last Updated
    March 10, 2021
    Sponsor
    Pace University
    Collaborators
    Emory University
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    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
    result
    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
    result
    PubMed Identifier
    27445970
    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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    PubMed Identifier
    17030751
    Citation
    Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.
    Results Reference
    result
    PubMed Identifier
    15087552
    Citation
    van der Lee JH, Beckerman H, Knol DL, de Vet HC, Bouter LM. Clinimetric properties of the motor activity log for the assessment of arm use in hemiparetic patients. Stroke. 2004 Jun;35(6):1410-4. doi: 10.1161/01.STR.0000126900.24964.7e. Epub 2004 Apr 15.
    Results Reference
    result

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    Music After Stroke To Enhance Rehabilitation

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