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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00727467

Enrollment

Registered

2008-08-04

Start date

2008-09-30

Completion date

2009-03-31

Last updated

2008-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

auditory cueing device, Parkinson's disease, freezing, gait, mobility

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.

Interventions

DEVICEAuditory 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Ireland

Contacts

Primary ContactEmma K Stokes, PhD

estokes@tcd.ie00353 1 896 2127

Backup ContactRose Galvin, BSc

rgalvin@tcd.ie003531 896 3613

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026