The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers
Primary Purpose
Stroke and Aphasia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communal singing
Sponsored by
About this trial
This is an interventional treatment trial for Stroke and Aphasia
Eligibility Criteria
Inclusion Criteria:
- Stroke victim, regardless of level of stroke
Exclusion Criteria:
- None
Sites / Locations
- Mount Sinai Beth IsraelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Communal singing
Control
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in mood and quality of life as indicated through saliva (cortisol and melatonin sampling)
Cortisol and melatonin sampling will be conducted at baseline and at 6 months
Secondary Outcome Measures
Change in language aphasia outcome improvement
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.
Full Information
NCT ID
NCT02328573
First Posted
June 23, 2014
Last Updated
March 14, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT02328573
Brief Title
The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers
Official Title
The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2014 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
Participants can attend zoom or live.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke and Aphasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Communal singing
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Communal singing
Primary Outcome Measure Information:
Title
Change in mood and quality of life as indicated through saliva (cortisol and melatonin sampling)
Description
Cortisol and melatonin sampling will be conducted at baseline and at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in language aphasia outcome improvement
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in motivation and verbal expression
Description
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)
Time Frame
6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stroke victim, regardless of level of stroke
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne Loewy, DA
Phone
212-420-3484
Email
joanne.loewy@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Loewy, DA
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Grippo
Phone
212-420-2704
Email
marie.grippo@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Joanne Loewy, DA
12. IPD Sharing Statement
Learn more about this trial
The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers
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