CuePD: Investigating the Effect of Personalised Auditory Cueing on Gait in Parkinson's Disease
NCT ID: NCT06941779
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2024-11-21
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cortical Correlates of Gait in Parkinson's Disease: Impact of Medication and Cueing
NCT05818189
Brain Activity During Gait in Parkinson's
NCT04863560
The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease
NCT03253965
Model-based Cueing-as-needed for Walking in Parkinson's Disease
NCT06073028
Effect of Haptic Cueing on Long-Range Autocorrelations in Parkinson's Disease Gait Variability
NCT05790759
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cueing
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
50 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
North Tyneside General Hospital
OTHER_GOV
Northumbria Healthcare NHS Foundation Trust
OTHER
Northumbria University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northumbria University
Newcastle, , United Kingdom
North Tyneside General Hospital
North Shields, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Brooke J. SUS: a retrospective. Journal of usability studies. 2013;8: 29-40. https://dl.acm.org/doi/10.5555/2817912.2817913
Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196.
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.
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.
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.
Rose D, Ott L, Guerin SMR, Annett LE, Lovatt P, Delevoye-Turrell YN. A general procedure to measure the pacing of body movements timed to music and metronome in younger and older adults. Sci Rep. 2021 Feb 5;11(1):3264. doi: 10.1038/s41598-021-82283-4.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
327241
Identifier Type: OTHER
Identifier Source: secondary_id
24/PR/0684
Identifier Type: OTHER
Identifier Source: secondary_id
CuePD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.