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Trial record 8 of 14 for:    music therapy | Stroke

The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers

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ClinicalTrials.gov Identifier: NCT02328573
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
The study will focus on the impact of communal singing on patients with stroke and their personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. The second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care

Condition or disease Intervention/treatment Phase
Stroke and Aphasia Behavioral: Communal singing Not Applicable

Detailed Description:

The study will focus on the impact of communal singing on patients with stroke and their personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. The second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care.

All enrolled participants will be assessed on their mood, past music experience and music genre preference (music therapy assessment). They will complete the abridged Beck (BDI-2-fastscreen) questionnaire, the stoke and aphasia quality of life scale; a Likert which measures distress; the Western Aphasia Battery (WAB); the NIH Stroke Scale (SS); the Figely compassion scale; and the driving scene test (Stern and White); and the Rankin. In additional we will take saliva samples from all participants to measure hormone levels.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers
Study Start Date : April 2014
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia Caregivers

Arm Intervention/treatment
Experimental: Communal singing
Participants in the study group will join the choir and participate in a weekly hour rehearsal for six months and will be assessed for aphasia, mood, and quality of life outcomes
Behavioral: Communal singing
No Intervention: Control
The control group will not participate in the choir for the first six months. At the end of the six months study period, all participants will be evaluated again for changes in aphasia, language, mood and quality of life



Primary Outcome Measures :
  1. Change in mood and quality of life as indicated through saliva (cortisol and melatonin sampling) [ Time Frame: 6 months ]
    Cortisol and melatonin sampling will be conducted at baseline and at 6 months


Secondary Outcome Measures :
  1. Change in language aphasia outcome improvement [ Time Frame: 6 months ]
    We will use the following scales as 6 month measurements, and will compare these scores to the initial assessments: Speech Therapy Evaluation-Western Aphasia Battery NIH Stroke Scale and Aphasia Quality of Life Scale.


Other Outcome Measures:
  1. Change in motivation and verbal expression [ Time Frame: 6 ]
    We will use the following scales as 6 month measurements, and will compare these scores to the initial assessments: Likert Scale Mood (Beck-BDI 2)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stroke victim, regardless of level of stroke

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328573


Contacts
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Contact: Joanne Loewy, DA 212-420-3484 jloewy@chpnet.org

Locations
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United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Marie Grippo    212-420-2704    mgrippo@chpnet.org   
Principal Investigator: Joanne Loewy, DA         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Joane Loewy, DA Beth Israel Medical Center

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02328573     History of Changes
Other Study ID Numbers: GCO 16-1215
001-14 ( Other Identifier: Beth Israel Medical Center )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms