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)

Phase 1

• Conditions: Parkinson's Disease
• Interventions: Device: Auditory Cueing Device

• Registration Number: NCT00727467
• Lead Sponsor: University of Dublin, Trinity College

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.

Study Timeline

• Study First Submitted: 2008-07-31
• Status Verified: 2008-08
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-04
• Study Start: 2008-09
• Primary Completion: 2008-12
• Last Update Submitted: 2008-12-30
• Last Update Posted: 2008-12-31
• Study Completion: 2009-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Auditory Cueing Device	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.
B	Auditory Cueing Device	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.

Primary Outcome Measures

Name	Time	Method
Freezing of Gait Questionnaire	Day 8, Day 15, Day 23 and 3 month follow up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Royal Hospital Donnybrook; 🇮🇪 Dublin, Ireland

Cork University Hospital; 🇮🇪 Cork, Ireland

Saint James's Hospital; 🇮🇪 Dublin, Ireland