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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Dublin, Trinity College.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Dublin, Trinity College
ClinicalTrials.gov Identifier:
NCT00727467
First received: July 31, 2008
Last updated: December 30, 2008
Last verified: August 2008

July 31, 2008
December 30, 2008
September 2008
December 2008   (final data collection date for primary outcome measure)
Freezing of Gait Questionnaire [ Time Frame: Day 8, Day 15, Day 23 and 3 month follow up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00727467 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)
A Randomised Controlled Trial Evaluating the Effect of an Individual Auditory Cueing Device on Freezing and Gait Speed in People With Parkinson's Disease

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
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.
Other Name: iPod shuffle
  • Experimental: 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.

    Intervention: Device: Auditory Cueing Device
  • Active Comparator: 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.

    Intervention: Device: Auditory Cueing Device
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
47
March 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Emma K Stokes, PhD 00353 1 896 2127 estokes@tcd.ie
Contact: Rose Galvin, BSc 003531 896 3613 rgalvin@tcd.ie
Ireland
 
NCT00727467
5-6-08
Yes
Dr. Emma Stokes, University of Dublin, Trinity College
University of Dublin, Trinity College
Not Provided
Principal Investigator: Emma K Stokes, PhD University of Dublin, Trinity College
University of Dublin, Trinity College
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP