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) - Full Text View

Sponsored by:	University of Dublin, Trinity College
Information provided by:	University of Dublin, Trinity College
ClinicalTrials.gov Identifier:	NCT00727467

Purpose

The primary aim of the study is to evaluate the effect of an IACD i.e. Apple iPod-shuffle, on freezing and gait speed in people with a diagnosis of PD through the implementation of a randomised controlled trial. A secondary aim of the study is to evaluate the impact of such a device on the quality of life of people with stroke through the administration of a self-report questionnaire. The IACD will be pre-loaded with an individualised auditory cueing frequency (metronome sound) matched to the walking speed of the individual with PD.

Condition	Intervention	Phase
Parkinson's Disease	Device: Auditory Cueing Device	Phase I Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Methamphetamine Parkinson's Disease

Drug Information available for: Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomised Controlled Trial Evaluating the Effect of an Individual Auditory Cueing Device on Freezing and Gait Speed in People With Parkinson's Disease

Further study details as provided by University of Dublin, Trinity College:

Primary Outcome Measures:

Freezing of Gait Questionnaire [ Time Frame: Day 8, Day 15, Day 23 and 3 month follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Timed Up and Go Test [ Time Frame: Day 8, Day 15, Day 23 and three month follow-up ] [ Designated as safety issue: No ]
Modified Falls Efficacy Scale [ Time Frame: Day 8, Day 15, Day 23 and three month follow-up ] [ Designated as safety issue: Yes ]
10 Metre Walk Test [ Time Frame: Day 8, Day 15, Day 23 and three month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	47
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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.	Device: 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: Active Comparator 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.	Device: 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.

Arms

Assigned Interventions

A: Experimental

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.

Device: 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: Active Comparator

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.

Device: 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.

Detailed Description:

The investigators calculated and pre-loaded 100 baseline frequencies (less 10%) in the sound of a metronome beat in an MP3 format (30 - 130 BPM) [38] onto a DVD-Rom. A user manual was created with a set of instructions that gives each physiotherapist a step-by-step guide on how to calculate the correct beat for their participants and how to successfully upload this beat onto the iPod. In addition physiotherapists in participating centres attended a training session on how to complete the tasks. A pack including the DVD-Rom, user manual, information leaflet and consent was sent to participating centres. Recruitment is due to commence in September 2008.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

PD
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:

attending physiotherapy at time of recruitment
unwilling to give informed consent
not medically stable
cognitive impairment (MMSE score less than 24)
acure co-morbidity that prevents mobility

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727467

Contacts

Contact: Emma K Stokes, PhD	00353 1 896 2127	estokes@tcd.ie
Contact: Rose Galvin, BSc	003531 896 3613	rgalvin@tcd.ie

Locations

Ireland
Royal Hospital Donnybrook
Dublin, Ireland
Saint James's Hospital
Dublin, Ireland
Cork University Hospital
Cork, Ireland

Sponsors and Collaborators

University of Dublin, Trinity College

Investigators

Principal Investigator:

Emma K Stokes, PhD

University of Dublin, Trinity College

More Information

Physiotherapy Research and Older People This link exits the ClinicalTrials.gov site

Responsible Party:	University of Dublin, Trinity College ( Dr. Emma Stokes )
Study ID Numbers:	5-6-08
Study First Received:	July 31, 2008
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00727467
Health Authority:	Ireland: Medical Ethics Research Committee

Keywords provided by University of Dublin, Trinity College:

auditory cueing device
Parkinson's disease
freezing
gait
mobility

Study placed in the following topic categories:

Methamphetamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Amphetamine
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009