About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

CuePD
Device
Use of the CuePD smartphone app to listen to musical cues.
Control material
Other intervention
Reading of leaflet and information booklet

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: CuePDExperimental treatment 1 intervention

Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame

24 weeks.

2

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).

Time frame

24 weeks

3

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).

Time frame

24 weeks

Secondary outcomes

1

Fall frequency

Use of a self-report falls diary to make a record of any fall or near fall event. The diary will consist of a calendar for participants to make a good record of the day and time as well as space to try and capture context of the event.

Time frame

24 weeks

2

Cost effectiveness

Client Services Receipt Inventory (CSRI) questionnaire. CSRI collects data on service use and has been used in many evaluations of health and social care interventions over the past 30-years. It records the interviewee's use of health and social care services, accommodation and living situation, income, employment and benefits. Service use data are combined with appropriate unit costs to generate total care costs/participant.

Time frame

24 weeks

3

Cost-utility analysis

The EQ-5D is a brief scale to measure health related quality of life (HRQoL) across 5-dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each domain participants are asked to rate their current health using a five-point scale, describing the extent to which they can perform activities ("No problems" to "Unable to perform"). It also includes a visual analogue scale on which participants mark their current status between 0 (worst health they can imagine) and 100 (best health they can imagine). Quality Adjusted Life Years (QALYs) will be derived from the EQ-5D scores for the cost-utility analysis.

Time frame

24-weeks

4

Perceptions

Participants (control and intervention) will be invited to focus groups to expand findings. Consenting views of (maximum) 10 CuePD intervention and 10 control participants will be sought in a series of focus groups. Focus groups will be separate to the main study and undertaken after the 12-week outcome assessments. Questions (e.g., did a care encourage use?) will explore participant experiences and factors influencing adherence. Focus groups will be voice recorded and transcripts will be analysed to identify themes and connections. A thematic analysis will analyse the focus group data as it is a flexible method that allows themes to emerge from the data and has previously been used by the team to analyse data following discussions relating to the technology to assess gait and reduce fall risk within PD. The thematic approach can produce insights via the participants voice to help answer the research questions.

Time frame

24 weeks

Retraining Gait in Parkinson's Disease Via a Personalised App

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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