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.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Auditory Cueing Device

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 Type: Interventional
• Enrollment (Anticipated): 47
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Emma K Stokes, PhD; Phone Number: 00353 1 896 2127; Email: estokes@tcd.ie
• Study Contact Backup: Name: Rose Galvin, BSc; Phone Number: 003531 896 3613; Email: rgalvin@tcd.ie

Study Locations

• Ireland
  • Cork, Ireland
    • Cork University Hospital
    • Contact: Eilis Ni Charthaigh, BSc; Phone Number: 353 21 454 6400
    • Principal Investigator: Eilis Ni Charthaigh, BSc
  • Dublin, Ireland
    • Royal Hospital Donnybrook
    • Contact: Ola Wyszumirska, BS c; Phone Number: 003531 4972844
    • Principal Investigator: Ola Wyszumirska
  • Dublin, Ireland
    • Saint James's Hospital
    • Contact: Sheila McCarthy, BSc; Phone Number: 0035314103000
    • Principal Investigator: Sheila McCarthy, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: iPod shuffle
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.	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 Names: iPod shuffle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freezing of Gait Questionnaire	Day 8, Day 15, Day 23 and 3 month follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Investigators: Principal Investigator: Emma K Stokes, PhD, University of Dublin, Trinity College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): December 1, 2008
• Study Completion (Anticipated): March 1, 2009

Study Registration Dates

• First Submitted: July 31, 2008
• First Submitted That Met QC Criteria: August 1, 2008
• First Posted (Estimate): August 4, 2008

Study Record Updates

• Last Update Posted (Estimate): December 31, 2008
• Last Update Submitted That Met QC Criteria: December 30, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: gait; mobility; Parkinson's disease; freezing; auditory cueing device
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 5-6-08