Clinical trial NCT00727467: 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)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Keywords: auditory cueing device
Parkinson's disease
freezing
gait
mobility
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2008-08-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Freezing of Gait Questionnaire
timeFrame: Day 8, Day 15, Day 23 and 3 month follow up
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: Day 8, Day 15, Day 23 and three month follow-up
measure: Modified Falls Efficacy Scale
timeFrame: Day 8, Day 15, Day 23 and three month follow-up
measure: 10 Metre Walk Test
timeFrame: Day 8, Day 15, Day 23 and three month follow-up
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Royal Hospital Donnybrook
city: Dublin
country: Ireland
facility: Saint James's Hospital
Study officials:
affiliation: University of Dublin, Trinity College
name: Emma K Stokes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.