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

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: Enrolling by invitation
• Conditions: Stroke and Aphasia
• Intervention / Treatment: Behavioral: Communal singing

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

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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	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	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

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Joanne Loewy, DA, Beth Israel Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2014
• Primary Completion (Actual): June 9, 2025
• Study Completion (Estimated): June 12, 2026

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 (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: GCO 16-1215; 001-14 (Other Identifier: Beth Israel Medical Center)

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No