A Randomised Controlled Trial (RCT) to Evaluate Use of an Individual Auditory Cueing Device's (IACD's) on Freezing and Gait in People With Parkinson's Disease (PD)
NCT ID: NCT00727467
Last Updated: 2008-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
47 participants
INTERVENTIONAL
2008-09-30
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A
On Days 1-8 of the trial, participants in Group A will be given the iPod with some music on the device to allow all participants to become familiar with the device i.e. turning device on and off, increasing and decreasing the volume. They will be instructed to use the device only when sitting at home, and that the device should not be turned on when walking or performing any mobility related or daily tasks.
On Days 8-15, participants in Group A will be allocated to the 'intervention' phase. Each participant will be given an iPod containing an auditory cue in the form of a continuous metronome beat, individualised to the patient's walking frequency (less 10%).Participants will be instructed to listen to the cueing when they are performing any mobility related tasks. On Days 15-23, participants in Group A will be allocated to the 'control' phase. During this time period, participants will be provided with the iPod shuffle containing no music or metronome beat.
Auditory Cueing Device
Each participant will be given an iPod containing an auditory cue in the form of a continuous metronome beat, individualised to the patient's walking frequency (less 10%).Participants will be instructed to listen to the cueing when they are performing any mobility related tasks.
B
On Days 1-8 of the trial, participants in Group B will be given the iPod with some music on the device to allow all participants to become familiar with the device. They will be instructed to use the device only when sitting at home, and that the device should not be turned on when walking or performing any mobility related or daily tasks.
On Days 8-15, participants in Group B will be allocated to the 'control' phase. During this time period, participants will be provided with the iPod shuffle containing no music or metronome beat. On Days 15-23, participants in Group B will be allocated to the 'intervention phase'. Each participant will be given an iPod containing an auditory cue in the form of a continuous metronome beat, individualised to the patient's walking frequency (less 10%).Participants will be instructed to listen to the cueing when they are performing any mobility related tasks.
Auditory Cueing Device
Each participant will be given an iPod containing an auditory cue in the form of a continuous metronome beat, individualised to the patient's walking frequency (less 10%).Participants will be instructed to listen to the cueing when they are performing any mobility related tasks.
Interventions
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Auditory Cueing Device
Each participant will be given an iPod containing an auditory cue in the form of a continuous metronome beat, individualised to the patient's walking frequency (less 10%).Participants will be instructed to listen to the cueing when they are performing any mobility related tasks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* medically stable
* willing to give informed consent
* freeze at least once per week (minimum score of 2 on item 3 of the FOGQ) for at least 2 seconds(minimum score of 1 on item 4 of FOGQ)
* MMSE Score greater than 24
Exclusion Criteria
* unwilling to give informed consent
* not medically stable
* cognitive impairment (MMSE score less than 24)
* acure co-morbidity that prevents mobility
18 Years
90 Years
ALL
No
Sponsors
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University of Dublin, Trinity College
OTHER
Responsible Party
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University of Dublin, Trinity College
Principal Investigators
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Emma K Stokes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Dublin, Trinity College
Locations
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Cork University Hospital
Cork, , Ireland
Royal Hospital Donnybrook
Dublin, , Ireland
Saint James's Hospital
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Eilis Ni Charthaigh, BSc
Role: primary
Ola Wyszumirska, BS c
Role: primary
Sheila McCarthy, BSc
Role: primary
References
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Ledger S, Galvin R, Lynch D, Stokes EK. A randomised controlled trial evaluating the effect of an individual auditory cueing device on freezing and gait speed in people with Parkinson's disease. BMC Neurol. 2008 Dec 11;8:46. doi: 10.1186/1471-2377-8-46.
Other Identifiers
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5-6-08
Identifier Type: -
Identifier Source: org_study_id