Back to resultsA 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)
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Phase 1
Locations
Ireland
Study Type
Interventional
Intervention
Auditory Cueing Device
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring auditory cueing device, Parkinson's disease, freezing, gait, mobility
Eligibility 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
Sites / Locations
- Cork University Hospital
- Royal Hospital Donnybrook
- Saint James's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Freezing of Gait Questionnaire
Secondary Outcome Measures
Timed Up and Go Test
Modified Falls Efficacy Scale
10 Metre Walk Test
Full Information
NCT ID
NCT00727467
First Posted
July 31, 2008
Last Updated
December 30, 2008
Sponsor
University of Dublin, Trinity College
1. Study Identification
Unique Protocol Identification Number
NCT00727467
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
March 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Dublin, Trinity College
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
auditory cueing device, Parkinson's disease, freezing, gait, mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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.
Arm Title
B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Auditory Cueing Device
Other Intervention Name(s)
iPod shuffle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Freezing of Gait Questionnaire
Time Frame
Day 8, Day 15, Day 23 and 3 month follow up
Secondary Outcome Measure Information:
Title
Timed Up and Go Test
Time Frame
Day 8, Day 15, Day 23 and three month follow-up
Title
Modified Falls Efficacy Scale
Time Frame
Day 8, Day 15, Day 23 and three month follow-up
Title
10 Metre Walk Test
Time Frame
Day 8, Day 15, Day 23 and three month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma K Stokes, PhD
Phone
00353 1 896 2127
Email
estokes@tcd.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Rose Galvin, BSc
Phone
003531 896 3613
Email
rgalvin@tcd.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma K Stokes, PhD
Organizational Affiliation
University of Dublin, Trinity College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eilis Ni Charthaigh, BSc
Phone
353 21 454 6400
First Name & Middle Initial & Last Name & Degree
Eilis Ni Charthaigh, BSc
Facility Name
Royal Hospital Donnybrook
City
Dublin
Country
Ireland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ola Wyszumirska, BS c
Phone
003531 4972844
First Name & Middle Initial & Last Name & Degree
Ola Wyszumirska
Facility Name
Saint James's Hospital
City
Dublin
Country
Ireland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila McCarthy, BSc
Phone
0035314103000
First Name & Middle Initial & Last Name & Degree
Sheila McCarthy, BSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
19077238
Citation
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.
Results Reference
derived
Learn more about this trial
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)
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