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)

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00727467
• Other study ID #: 5-6-08
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 31, 2008
• Last updated: December 30, 2008
• Start date: September 2008
• Est. completion date: March 2009

Study information

• Verified date: August 2008
• Source: University of Dublin, Trinity College
• Contact: Emma K Stokes, PhD
• Phone: 00353 1 896 2127
• Email: estokes[@]tcd.ie
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 47
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
Ireland	Cork University Hospital	Cork
Ireland	Royal Hospital Donnybrook	Dublin
Ireland	Saint James's Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freezing of Gait Questionnaire		Day 8, Day 15, Day 23 and 3 month follow up	Yes
Secondary	Timed Up and Go Test		Day 8, Day 15, Day 23 and three month follow-up	No
Secondary	Modified Falls Efficacy Scale		Day 8, Day 15, Day 23 and three month follow-up	Yes
Secondary	10 Metre Walk Test		Day 8, Day 15, Day 23 and three month follow-up	No

External Links

•   Physiotherapy Research and Older People