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)
1 other identifier
interventional
47
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2008
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2008
CompletedFirst Posted
Study publicly available on registry
August 4, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedDecember 31, 2008
August 1, 2008
3 months
July 31, 2008
December 30, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freezing of Gait Questionnaire
Day 8, Day 15, Day 23 and 3 month follow up
Secondary Outcomes (3)
Timed Up and Go Test
Day 8, Day 15, Day 23 and three month follow-up
Modified Falls Efficacy Scale
Day 8, Day 15, Day 23 and three month follow-up
10 Metre Walk Test
Day 8, Day 15, Day 23 and three month follow-up
Study Arms (2)
A
EXPERIMENTALOn 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.
B
ACTIVE COMPARATOROn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cork University Hospital
Cork, Ireland
Royal Hospital Donnybrook
Dublin, Ireland
Saint James's Hospital
Dublin, Ireland
Related Publications (1)
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.
PMID: 19077238DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emma K Stokes, PhD
University of Dublin, Trinity College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 31, 2008
First Posted
August 4, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2008
Study Completion
March 1, 2009
Last Updated
December 31, 2008
Record last verified: 2008-08