NCT00368511

Brief Summary

We propose to obtain computerized dynamic posturography scores on patients in a (psycho)geriatric nursing home utilizing the CAPS system from Vestibular Technology. This instrument has been validated to measure human stability and is associated with a Fall Probability percentage. Subjects will be asked to stand on a platform with eyes open and closed for approximately 30 seconds. The data obtained will be utilized as a base for change which can be compared to an outcome of music listening and fall prevention. Previous investigations have demonstrated a decrease in fall rates associated with music listening. We would like to measure the changes in human stability associated with a potential decrease in fall rates. We would also like to use the history of falls of the tested individuals if available. In case fall statistics are available we respectfully request access to all falls data available from the involved geriatric nursing home . The falls data will be kept confidential and only used as a control statistic in our evaluation of fall rates after implementation of our applications. The music used will include Nolwenn Leroy, Mozart and other Dutch and French Singers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2006

Shorter than P25 for early_phase_1

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

August 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

7 months

First QC Date

August 23, 2006

Last Update Submit

May 5, 2008

Conditions

Keywords

Fall PreventionDynamic PosturographyNolwenn EffectMusic Listening

Outcome Measures

Primary Outcomes (1)

  • Historical Falls Data

    Historical

Study Arms (1)

1

NO INTERVENTION

Listening to music and posture changes

Procedure: Music Listening

Interventions

Listen to music and posture measurements

1

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be a full time in patient in a geriatric hospital in Holland

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carrick Institute for Graduate Studies-Gouda Netherlands

Gouda, Netherlands

Location

Study Officials

  • Roland Blaauw, DC, DABCN

    Carrick Institute for Graduate Studies

    STUDY DIRECTOR
  • Arjan Kuipers, DC, DABCN

    Carrick Institute for Graduate Studies

    PRINCIPAL INVESTIGATOR
  • Marko Blanker, MD, PhD

    Carrick Institute for Graduate Studies

    PRINCIPAL INVESTIGATOR
  • Frederick Carrick, PhD, FACCN, FICC

    Carrick Institute for Graduate Studies

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 24, 2006

Study Start

August 1, 2006

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations