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

NCT06941779 | Completed

• 3 other identifiers: CuePD32724124/PR/0684
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson's Disease (PD)

Keywords

Wearables; Personalised cueing; Gait retraining

Outcome Measures

Primary Outcomes (4)

• Gait speed (m/s)

  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)

  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

  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)

  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 Outcomes (8)

• Montreal Cognitive Assessment (MoCA)

  15 mins

• MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  40 mins

• Physical Activity Questionnaire Short Form (IPAQ-SF)

  5 mins

• Physical activity

  5 minutes

• Falls history

  5 mins

Study Arms (1)

Cueing

EXPERIMENTAL

Device: Cueing

Interventions

Cueing DEVICE

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.

Cueing

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• North Tyneside General Hospital: collaborator
• Northumbria Healthcare NHS Foundation Trust: collaborator

Study Sites (2)

Northumbria University

Newcastle, United Kingdom

Location

North Tyneside General Hospital

North Shields, United Kingdom

Location

Related Publications (14)

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  BACKGROUND

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  PMID: 16267188 BACKGROUND

• Voorrips LE, Ravelli AC, Dongelmans PC, Deurenberg P, Van Staveren WA. A physical activity questionnaire for the elderly. Med Sci Sports Exerc. 1991 Aug;23(8):974-9.

  PMID: 1956274 BACKGROUND

• Tolosa E, Garrido A, Scholz SW, Poewe W. Challenges in the diagnosis of Parkinson's disease. Lancet Neurol. 2021 May;20(5):385-397. doi: 10.1016/S1474-4422(21)00030-2.

  PMID: 33894193 BACKGROUND

• Sweeney D, Quinlan LR, Browne P, Richardson M, Meskell P, OLaighin G. A Technological Review of Wearable Cueing Devices Addressing Freezing of Gait in Parkinson's Disease. Sensors (Basel). 2019 Mar 13;19(6):1277. doi: 10.3390/s19061277.

  PMID: 30871253 BACKGROUND

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  PMID: 33547366 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• Mullensiefen D, Gingras B, Musil J, Stewart L. The musicality of non-musicians: an index for assessing musical sophistication in the general population. PLoS One. 2014 Feb 26;9(2):e89642. doi: 10.1371/journal.pone.0089642. eCollection 2014.

  PMID: 24586929 BACKGROUND

• Movement Disorder Society Task Force on Rating Scales for Parkinson's Disease. The Unified Parkinson's Disease Rating Scale (UPDRS): status and recommendations. Mov Disord. 2003 Jul;18(7):738-50. doi: 10.1002/mds.10473.

  PMID: 12815652 BACKGROUND

• Fiorente N, Calabro RS. Music in Parkinson's Disease Rehabilitation: Are We Heading in the Right Direction? Innov Clin Neurosci. 2023 Spring;20(4-6):11-13.

  PMID: 37387705 BACKGROUND

• Dotov DG, Cochen de Cock V, Geny C, Ihalainen P, Moens B, Leman M, Bardy B, Dalla Bella S. The role of interaction and predictability in the spontaneous entrainment of movement. J Exp Psychol Gen. 2019 Jun;148(6):1041-1057. doi: 10.1037/xge0000609.

  PMID: 31180717 BACKGROUND

• GBD 2016 Parkinson's Disease Collaborators. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953. doi: 10.1016/S1474-4422(18)30295-3. Epub 2018 Oct 1.

  PMID: 30287051 BACKGROUND

• Allen NE, Schwarzel AK, Canning CG. Recurrent falls in Parkinson's disease: a systematic review. Parkinsons Dis. 2013;2013:906274. doi: 10.1155/2013/906274. Epub 2013 Mar 5.

  PMID: 23533953 BACKGROUND

• Wall C, McMeekin P, Hetherington V, Morris R, Vitorio R, Walker R, Godfrey A. Retraining gait in Parkinson's Disease via a personalised app: A study protocol. PLoS One. 2026 Apr 15;21(4):e0346508. doi: 10.1371/journal.pone.0346508. eCollection 2026.

  PMID: 41984908 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 24, 2025
• Study Start: November 21, 2024
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-03

Locations

GB (2)