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
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Device: Auditory Cueing Device
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Dublin, Trinity College:

Primary Outcome Measures:
  • Freezing of Gait Questionnaire [ Time Frame: Day 8, Day 15, Day 23 and 3 month follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 47
Study Start Date: September 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: iPod shuffle

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727467

Contacts
Contact: Emma K Stokes, PhD 00353 1 896 2127 estokes@tcd.ie
Contact: Rose Galvin, BSc 003531 896 3613 rgalvin@tcd.ie

Locations
Ireland
Cork University Hospital Not yet recruiting
Cork, Ireland
Contact: Eilis Ni Charthaigh, BSc    353 21 454 6400      
Principal Investigator: Eilis Ni Charthaigh, BSc         
Royal Hospital Donnybrook Not yet recruiting
Dublin, Ireland
Contact: Ola Wyszumirska, BS c    003531 4972844      
Principal Investigator: Ola Wyszumirska         
Saint James's Hospital Not yet recruiting
Dublin, Ireland
Contact: Sheila McCarthy, BSc    0035314103000      
Principal Investigator: Sheila McCarthy, BSc         
Sponsors and Collaborators
University of Dublin, Trinity College
Investigators
Principal Investigator: Emma K Stokes, PhD University of Dublin, Trinity College
  More Information

Additional Information:
No publications provided by University of Dublin, Trinity College

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Emma Stokes, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT00727467     History of Changes
Other Study ID Numbers: 5-6-08
Study First Received: July 31, 2008
Last Updated: December 30, 2008
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by University of Dublin, Trinity College:
auditory cueing device
Parkinson's disease
freezing
gait
mobility

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 30, 2014