NCT00304564

Brief Summary

Falls are the largest cause of death in the elderly and those in nursing homes have even a higher incidence of falling. The purpose of this study is to determine whether listening to the Music of Nolwenn Leroy daily is effective in fall prevention in those elderly patients who are residents in several Texas geriatric nursing home facilities. The music of Nolwenn Leroy has been shown to be effective in fall reduction in a different setting (Posturographic Changes and Fall Prevention associated with Music Therapy: The Nolwenn Effect (USA ClinicalTrials.gov Identifier: NCT00121693) )with results better than listening to Mozart of any other music. Another similar study (USA ClinicalTrials.gov Identifier:NCT00272272)is presently being conducted in a geriatric nursing home facility in Georgia. Dynamic posturographic measurments will be obtained from all residents and compared to normative age related data and utilized to measure stability changes in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 20, 2006

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

March 15, 2006

Last Update Submit

January 26, 2016

Conditions

Accidental Falls

Keywords

Posturography, Fall Prevention, Geriatrics, Nolwenn Effect

Outcome Measures

Primary Outcomes (2)

  • Dynamic Posturography

    immediate pre and post music listening

  • Historical Falls related Institutional Data

    From initial admissin to nursing home to present

Study Arms (1)

geriatric community

EXPERIMENTAL

Subject will stand on a computerized posturography force plate and stability scores are measured

Behavioral: Music Listening

Interventions

Music ListeningBEHAVIORAL

subjects listen to music

geriatric community

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Geriatric Nursing Home Resident must be able to hear music

You may not qualify if:

  • Deafness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carrick Institute for Graduate Studies

Flower Mound, Texas, 75028-7596, United States

Location

Study Officials

  • Frederick R Carrick, PhD, FACCN

    Carrick Institute for Graduate Studies

    STUDY DIRECTOR

  • Natalie J Engelbart, DC, DACNB

    Carrick Institute for Graduate Studies

    PRINCIPAL INVESTIGATOR

  • Michaele Sporaco, DC

    Carrick Institute for Graduate Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2006

First Posted

March 20, 2006

Study Start

February 1, 2006

Primary Completion

April 1, 2006

Study Completion

March 1, 2007

Last Updated

January 27, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)