Music After Stroke To Enhance Rehabilitation

Not Applicable

• Conditions: Expressive Aphasia; Stroke, Acute; Depressive Disorder; Movement, Abnormal
• Interventions: Device: ipod with books to listen; Device: Ipod with music; Device: ipod only with usual care

• Registration Number: NCT04441515
• Lead Sponsor: Pace University

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.

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-22
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-11
• Study Start: 2021-04-30
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral books	ipod with books to listen	Listening to books on ipod
Music	Ipod with music	music supplied by ipod
usual care	ipod only with usual care	Usual care

Primary Outcome Measures

Name	Time	Method
expressive aphasia measured by use of the WAB-R	6 months	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	6 months	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.
Quality of life as measured using the 20 item short form survey (SF-20)	6 months	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.
Depressive symptoms as measured using the PHQ-9	6 months	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.