Music After Stroke To Enhance Rehabilitation

NCT04441515 | Unknown

• 1 other identifier: MASTER1
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke, Acute; Expressive Aphasia; Movement, Abnormal; Depressive Disorder

Outcome Measures

Primary Outcomes (4)

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

Study Arms (3)

Music

EXPERIMENTAL

music supplied by ipod

Device: Ipod with music

oral books

ACTIVE COMPARATOR

Listening to books on ipod

Device: ipod with books to listen

usual care

PLACEBO COMPARATOR

Usual care

Device: ipod only with usual care

Interventions

Ipod with music DEVICE

music of patient's preference provided 2 hours daily

Music

ipod with books to listen DEVICE

2 hours of daily listening to books

oral books

ipod only with usual care DEVICE

participants given device only

usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pace University: lead
• Emory University: collaborator

Related Publications (13)

• Flanagan J. (1978). A research approach to improving our quality of life. American Psychologist, 33, 138-147.

  BACKGROUND

• Kertesz, A. (2006). Western Aphasia Battery-Revised. San Antonio, TX: Pearson.

  BACKGROUND

• 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.

  PMID: 23613966 RESULT

• 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.

  PMID: 10350414 RESULT

• 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.

  PMID: 22215032 RESULT

• 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.

  PMID: 28093560 RESULT

• 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.

  PMID: 11556941 RESULT

• 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.

  PMID: 29367334 RESULT

• 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.

  PMID: 19158063 RESULT

• 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.

  PMID: 10568646 RESULT

• 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.

  PMID: 27445970 RESULT

• 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.

  PMID: 17030751 RESULT

• 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.

  PMID: 15087552 RESULT

MeSH Terms

Conditions

Stroke; Aphasia, Broca; Dyskinesias; Depressive Disorder

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Mood Disorders; Mental Disorders

Study Officials

• Millie Hepburn, PhD

  Pace University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Millie Hepburn, PhD

CONTACT

9147733367; mhepburnsmith@pace.edu

Lori Sutherly, MS

CONTACT

4192960978; lori.j.sutherly@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 22, 2020
• Study Start: April 30, 2021
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share