NCT07584993

Brief Summary

Introduction Parkinson's disease (PD) limits mobility by worsening gait/walking and increasing fall risk. Falls lead to injuries and reduce confidence in performing everyday tasks. That lowers a person's ability to participate in community activities such as going to the shops or visiting friends, which reduces their quality of life. Development of interventions for gait impairments and falls is a research priority for Parkinson's UK. Understanding gait Traditionally, one approach a physiotherapist may use to try and improve/retrain a person's gait is with an electronic metronome which is a device that "beeps" nearly every second. The physiotherapist sets the metronome beeping, and the person tries to step to each beep. However, success depends on the physio's expertise/experience. Regardless, beeping sounds are described as boring. Smartphone app An app may be the solution. Smartphones have many sensors, meaning they can accurately measure gait but also deliver retraining via music. That is possible by the creation of an "app" that can be downloaded and installed on anyone's smartphone. Research proposal The investigators have developed and validated an app (CuePD) that uses music for gait retraining, to make it more enjoyable by having people listen to their preferred music. The aim for this study is to get people with PD (PwPD) using CuePD in their home and when out walking for 12-weeks to determine: (i) how PwPD use and value CuePD and (ii) CuePD's ability to improve gait to reduce fall risk.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 13, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

April 28, 2026

Last Update Submit

May 8, 2026

Conditions

PARKINSON DISEASE (Disorder)

Keywords

WearablesPersonalised cueingGait retraining

Outcome Measures

Primary Outcomes (3)

  • Gait speed

    Assessed by the CuePD app on the person's own smartphone (attached to the lower back by a belt attachment) while walking for 1-min. CuePD uses validated gait algorithms (Wall et al https://doi.org/10.1016/j.eswa.2025.128090).

    24 weeks.

  • Stride length

    Assessed by the CuePD app on the person's own smartphone (attached to the lower back by a belt attachment) while walking for 1-min. CuePD uses validated gait algorithms (Wall et al https://doi.org/10.1016/j.eswa.2025.128090).

    24 weeks

  • Step time coefficient of variation

    Assessed by the CuePD app on the person's own smartphone (attached to the lower back by a belt attachment) while walking for 1-min. CuePD uses validated gait algorithms (Wall et al https://doi.org/10.1016/j.eswa.2025.128090).

    24 weeks

Secondary Outcomes (4)

  • Fall frequency

    24 weeks

  • Cost effectiveness

    24 weeks

  • Cost-utility analysis

    24-weeks

  • Perceptions

    24 weeks

Study Arms (2)

CuePD

EXPERIMENTAL

Receive use of the CuePD app.

Device: CuePD

Control

ACTIVE COMPARATOR

Use of reading material

Other: Control material

Interventions

CuePDDEVICE

Use of the CuePD smartphone app to listen to musical cues.

CuePD
Control materialOTHER

Reading of leaflet and information booklet

Control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to walk unaided.
  • Diagnosis of idiopathic Parkinson's.
  • Score ≥21/30 on Montreal Cognitive Assessment (MoCA) which is used to classify non-demented Parkinson's (Parkinson's dementia is \<21/30).
  • Uses a smartphone.

You may not qualify if:

  • Non-English speakers
  • Use of any mobility aids e.g., walking stick
  • History of stroke, traumatic brain injury or other neurological disorders (other than Parkinson's)
  • Unable to comply with the testing protocol or currently participating in another interfering research project.
  • Does not use a smartphone.
  • Body mass index ≥35 (i.e., severe to morbid obesity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, United Kingdom

Location

Related Publications (6)

  • CuePD: An IoT approach for Enhancing Gait Rehabilitation in older adults through Personalised Music Cueing. Conor Wall, Fraser Young, Peter McMeekin, Victoria Hetherington, Richard Walker, Rosie Morris, Gill Barry, Yunus Celik, Alan Godfrey. IEEE Sensors Letters. 8(10). 2024. https://doi.org/10.1109/LSENS.2024.3456855

    BACKGROUND

  • A scalable and personal approach to gait rehabilitation beyond the clinic. Conor Wall, Peter McMeekin, Victoria Hetherington, Rosie Morris, Rodrigo Vitorio, Richard Walker, Alan Godfrey. Volume 285, 1 August 2025, 128090. Expert Systems with Applications.

    BACKGROUND

  • McCue P, Del Din S, Hunter H, Lord S, Price CIM, Shaw L, Rodgers H, Rochester L, Moore SA. Auditory rhythmical cueing to improve gait and physical activity in community-dwelling stroke survivors (ACTIVATE): study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2020 May 19;6:68. doi: 10.1186/s40814-020-00605-1. eCollection 2020.

    PMID: 32467770BACKGROUND

  • Hausdorff JM, Lowenthal J, Herman T, Gruendlinger L, Peretz C, Giladi N. Rhythmic auditory stimulation modulates gait variability in Parkinson's disease. Eur J Neurosci. 2007 Oct;26(8):2369-75. doi: 10.1111/j.1460-9568.2007.05810.x.

    PMID: 17953624BACKGROUND

  • Nieuwboer A, Kwakkel G, Rochester L, Jones D, van Wegen E, Willems AM, Chavret F, Hetherington V, Baker K, Lim I. Cueing training in the home improves gait-related mobility in Parkinson's disease: the RESCUE trial. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):134-40. doi: 10.1136/jnnp.200X.097923.

    PMID: 17229744BACKGROUND

  • Totton N, Lin J, Julious S, Chowdhury M, Brand A. A review of sample sizes for UK pilot and feasibility studies on the ISRCTN registry from 2013 to 2020. Pilot Feasibility Stud. 2023 Nov 21;9(1):188. doi: 10.1186/s40814-023-01416-w.

    PMID: 37990337BACKGROUND

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Alan Godfrey, PhD

CONTACT

01912273642alan.godfrey@northumbria.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 13, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 13, 2026

Record last verified: 2026-04

Locations

GB(1)