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

Stroke and Aphasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02328573
• Other study ID #: GCO 16-1215
• Secondary ID: 001-14
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2014
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Joanne Loewy, DA
• Phone: 212-420-3484
• Email: joanne.loewy[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stroke victim, regardless of level of stroke

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Aphasia
• Stroke
• Stroke and Aphasia

Intervention

Behavioral:
• Communal singing

Locations

Country	Name	City	State
United States	Mount Sinai Beth Israel	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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