NCT02328573

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Apr 2014Jun 2026

Study Start

First participant enrolled

April 4, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2026

Expected
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

11.2 years

First QC Date

June 23, 2014

Last Update Submit

June 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in language aphasia outcome improvement

    6 months

Other Outcomes (1)

  • Change in motivation and verbal expression

    6

Study Arms (2)

Communal singing

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Communal singing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke victim, regardless of level of stroke

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

StrokeAphasia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joanne Loewy, DA

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor, Family Medicine & Community Health

Study Record Dates

First Submitted

June 23, 2014

First Posted

December 31, 2014

Study Start

April 4, 2014

Primary Completion

June 9, 2025

Study Completion (Estimated)

June 12, 2026

Last Updated

June 15, 2025

Record last verified: 2025-06

Locations