Clinical trial NCT06941779: CuePD: Investigating the Effect of Personalised Auditory Cueing on Gait in Parkinson's Disease
Official title: CuePD: Investigating the Effect of Personalised Auditory Cueing on Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson&#39;s Disease (PD)
Keywords: Wearables
Personalised cueing
Gait retraining
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: North Tyneside General Hospital
name: Northumbria Healthcare NHS Foundation Trust
First posted: 2025-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait speed (m/s)
timeFrame: 1 hour
measure: Step length (m)
timeFrame: 1 hour
measure: Step time variability
timeFrame: 1 hour
measure: Cadence (steps/minute)
timeFrame: 1 hour
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 15 mins
measure: MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 40 mins
measure: Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: 5 mins
measure: Physical activity
timeFrame: 5 minutes
measure: Falls history
timeFrame: 5 mins
measure: Falls efficacy
timeFrame: 5 mins
measure: Musical sophistication
timeFrame: 10 mins
measure: System usability
timeFrame: 5 mins.
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Northumbria University
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
Study officials:
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