CuePD: Investigating the Effect of Personalised Auditory Cueing on Gait in Parkinson's Disease (CuePD)

April 28, 2026 updated by: Northumbria University

Parkinson's Disease (PD) is a major cause of disability, globally. PD affects a person's movement speed, fluency, quality, and ease of walking. PD has the fastest-growing incidence rate, with its prevalence expected to double over the next three decades, currently affecting 10 million people worldwide. PD often leads to disturbances in walking/gait characteristics such as abnormal/variable stride lengths and step times. Those disturbances increase the risk of falls, with about 39% of people with PD (PwPD) experiencing an average of 20.8 falls/year.

Research has examined cueing by leveraging auditory, visual, and tactile cues to normalize variable gait characteristics and improve mobility to reduce falls. Auditory cueing is the most effective at improving gait and most practical to apply in all settings (via headphones) but one size does not fit all when using auditory cueing paradigms i.e., there is a need for personalised approaches to ensure cueing interventions are tailored to the individual and their specific functional limitations. Furthermore, the long-term effectiveness of auditory mechanisms (e.g., metronome-based repetitive beep) suffer from their lack of continuous engagement.

This research project aims to examine personalised auditory cueing to improve gait in PwPD. Inertial sensors will capture and analyze validated gait-related characteristics and personalised auditory cues will be examined for their ability to correct variable gait. To reduce burden on PwPD (i.e., minimal number of wearable sensors) and to streamline data capture and deliver auditory cues, a single smartphone will be used only.

The project involves a multidisciplinary study between Computing and Exercise and Rehabilitation at Northumbria University, testing cueing modalities in a controlled laboratory environment under trained researcher supervision. The study will enrol PwPD, focusing on the ability of personalised auditory cueing to improve gait and PwPD preference of auditory cues.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A researcher will contact identified participants to explain the study further and provide the approved patient information sheet (PIS, via post or email - subject to the potential participant's preference). If after reading the information the potential participant is agreeable, arrangements will be made to book a suitable date and time to visit the Clinical Gait Laboratory, Coach Lane Campus, Northumbria University. Arrangements will be made to ensure the participant has clarity on how s/he can attend the Lab e.g., mode of transport and accessibility.

Upon attending the gait lab informed written consent procedures will be undertaken, then participants (n=60) will be required to answer some demographic questions, such as education level, falls history and activity level. They they will complete pen and paper based clinical assessments such as the Unified Parkinson's Disease Rating scale (UPDRS), Montreal Cognitive Assessment (MoCA), Falls Efficacy Scale-International (FES-I), Falls History Questionnaire, International Physical Activity Questionnaire and Physical Activity questionnaire for Elderly.

Upon completion of the above pen-and-paper tasks, all participants will engage in walking/gait-based tests that assess the effectiveness of a personalised auditory cueing on their gait. All assessments will take place at the Coach Lane Clinical Gait Lab, Northumbria University. During the session, all participants will be asked to wear a smartphone on their person (lower-back via belt attachment), as well as a pair of headphones over their ears and a wearable sensor on each of their feet (the latter are commercial reference standard wearables will be worn on the feet as a gold standard comparison to verify gait data from the smartphone).

Participants will then be asked to perform a series of forward walks around a 25m loop for 1 minute while trying to match their steps to the metronome and musical beats. Walk #1 will determine baseline stepping cadence for each participant. During walks #2-#4 the participant will listen to metronome and musical beats at a +10% increase on the cadence measured during walk #1. After walks #2 and #3, participants will (i) count backwards in their head from 30 to 0 in increments of 1 to disengage psychological responses evoked by each cueing modality and minimize any carryover effects and (ii) perform a 1 min walk with no cue at usual pace.

Specifically, walks and wash-out are:

  • Walk 1: Walk for 1-minute at usual pace to determine baseline gait cadence (listening to no sound or no music),

    >> No washout,

  • Walk 2: Walk for 1-minute with metronome cueing set at +10% baseline cadence,

    >> Washout (count backwards from 30 to 0 in increments of 1 + 1min walk no cue),

  • Walk 3: Walk for 1-minute with instrumental music cueing set at +10% baseline cadence,

    >> Washout (count backwards from 30 to 0 in increments of 1 + 1min walk no cue),

  • Walk 4: Walk for 1-minute with vocal music cueing set at +10% baseline cadence.

After the walks, all participants will be asked to answer some questions in the form of a semi-structured interview to explore their experiences of the personalised auditory cueing, administered via a smartphone (System Usability Scale). Goldsmiths Musical Sophistication Index will be used to examine participants' musical experience and skills, and provide valuable insights into the potential of the personalised auditory cueing approach to enhance gait in PwPD. Total time for lab participation is approx 1-hour. The immediate impact of personalised auditory cueing on gait performance in participants will be evaluated based on the collected data and participants' experiences.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Newcastle, United Kingdom
        • Northumbria University
      • North Shields, United Kingdom
        • North Tyneside General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Able to walk unaided.
  • Diagnosis of idiopathic PD, as defined by the UK Brain Bank criteria.
  • Score ≥21/30 on Montreal Cognitive Assessment (MoCA) which is used to classify non-demented PD (PD dementia is <21/30).

Exclusion Criteria:

  • Non-English speakers
  • History of stroke, traumatic brain injury or other neurological disorders (other than PD)
  • Acute lower back or lower extremity pain, peripheral neuropathy, and musculoskeletal disorders that would affect tasks.
  • Unstable medical condition including cardio-vascular instability in the past 6 months
  • Unable to comply with the testing protocol or currently participating in another interfering research project

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cueing
Device: Cueing
Inertial sensors (via a smartphone worn on the lower back) will capture and analyze validated gait-related characteristics (via a gold-standard inertial system worn on both feet). Personalised auditory cues (via smartphone) will be examined for their ability to correct variable gait. To reduce burden on participants (i.e., minimal number of wearable sensors) and to streamline data capture and deliver auditory cues, a single smartphone and a gold standard reference (2 inertial wearables on each foot) will only be used. All devices attached over clothes via belt attachments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed (m/s)
Time Frame: 1 hour
Average speed of walking in metres per second (m/s) during a 1 minute walk. Measured by the smartphone/IMU via gait-based algorithms located on the lower back.
1 hour
Step length (m)
Time Frame: 1 hour
Distance between consecutive steps measured in metres (m). Measured by the smartphone/IMU via gait-based algorithms located on the lower back.
1 hour
Step time variability
Time Frame: 1 hour
Coefficient of variation of step time (between consecutive steps). Derrived from the smartphone/IMU via gait-based algorithms located on the lower back. This outcome will determine variability between steps as a proxy for gait stability.
1 hour
Cadence (steps/minute)
Time Frame: 1 hour
Calculated as number of steps achieved in one minute (i.e., steps/minute). Derrived from the smartphone/IMU via gait-based algorithms located on the lower back to quantify steps during the 1-min walk.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA)
Time Frame: 15 mins
Administered as a screening tool to exclude those with cognitive impairment with <21 being a cut-off point for PwPD. The MoCA will be used as a standardised neuropsychological test acknowledged as a valid and efficient tool for the rapid screening of global cognitive dysfunction (Nasreddine, 2005). It is used to examine diverse cognitive domains including attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation.
15 mins
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame: 40 mins
Commonly employed to evaluate both motor and non-motor symptoms associated with PD (MDSTF, 2003). This scale consists of four main sections, each targeting a specific area of evaluation. The first part examines non-motor experiences that occur during daily living, while the second part assesses motor experiences during daily living. The third part evaluates motor examination, while the fourth part focuses on assessing complications related to therapy. To determine the severity of the symptoms, the UPDRS is scored based on a total of 195 points, where higher scores suggest increasing levels of disability.
40 mins
Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame: 5 mins
The International Physical Activity Questionnaire Short Form (IPAQ-SF) will be used to assesses the types of intensity of physical activity and sitting time to estimate total physical activity in MET-min/week and time spent sitting (Craig, 2003).
5 mins
Physical activity
Time Frame: 5 minutes
In addition to the IPAQ-SF and to concisely capture physical activity across a range of habitual tasks a secondary physical activity questionnaire will be used. Specifically, the physical activity questionnaire for the elderly with a reference period of 1-year will be used to understand functional household (e.g., cleaning) and community-based activities e.g., shopping (Voorips, 1991).
5 minutes
Falls history
Time Frame: 5 mins
Falls incidence, cause, location and consequences in the previous 12-months will be assessed by a questionnaire based on recommendations (Lamb 2005, Lord 2007), that leads with the question "In the past year, have you had any fall including a slip or trip in which you lost your balance and landed on the floor or ground or lower level?" (Yardley, 2005).
5 mins
Falls efficacy
Time Frame: 5 mins
Used to measure fear of falling in the people with PD (Yardley, 2005). This short, validated measure will assess fear of falling during both basic and demanding activities (physical and social) using a scale from 1 (Not at all concerned) to 4 (Very concerned) across 16 scenarios.
5 mins
Musical sophistication
Time Frame: 10 mins
Goldsmiths Musical Sophistication Index (Gold-MSI): A 39-item (scored from 1 to 7) self-report designed to assess musicality across five subscales: active engagement (AE), perceptual abilities (PA), musical training (MT), singing abilities (SA), and emotional response (ER) to music (Müllensiefen, 2014). This tool evaluates and provides the detailed extent and nature of musical experiences and skills, but also provides a broader score on musicality, General Music Sophistication (GMS), ranging from 32 to 126. For this study, the scale will be used to assess if there was a relationship between an individual's general music sophistication and their adherence to the beat of the music cues. Furthermore, the relationship between an individual's subscale results and beat adherence will also be assessed.
10 mins
System usability
Time Frame: 5 mins.
System Usability Scale (SUS). This will evaluate perceptions of the app's usability, complexity, and overall satisfaction (Brooke, 2013). The SUS produces a composite score that ranges from 0 to 100, calculated by first adjusting the responses from a set of ten questions. For odd-numbered questions, the process involves subtracting one from each score, whereas for even-numbered questions, the score is subtracted from five, resulting in adjusted values that fall between 0 and 4. These adjusted values are subsequently summed together, and the total is multiplied by 2.5 to derive the final SUS score, with higher scores reflecting superior usability.
5 mins.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Collaborators

North Tyneside General Hospital
Northumbria Healthcare NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Actual)

March 19, 2026

Study Completion (Actual)

March 19, 2026

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CuePD
  • 327241 (Other Identifier: Integrated Research Application System)
  • 24/PR/0684 (Other Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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