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

February 13, 2024 updated by: Joanne Loewy, Icahn School of Medicine at Mount Sinai
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • Mount Sinai Beth Israel
        • Contact:
        • Principal Investigator:
          • Joanne Loewy, DA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stroke victim, regardless of level of stroke

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Joanne Loewy, DA, Beth Israel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2014

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimated)

December 31, 2014

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 16-1215
  • 001-14 (Other Identifier: Beth Israel Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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