Parkinson's Disease (PD)CuePDNCT06941779
CuePD: Investigating the Effect of Personalised Auditory Cueing on Gait in Parkinson's Disease
A study testing Cueing in people with Parkinson's Disease (PD), run by Northumbria University at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Cueing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 21 Nov 2024to 19 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Northumbria University
Newcastle
North Tyneside General Hospital
North Shields
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Cueing
- Keywords
- Wearables, Personalised cueing, Gait retraining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CueingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cueing | Experimental | Not described Receives: Device: Cueing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hour
Secondary outcomes (8)
Montreal Cognitive Assessment (MoCA)
Administered as a screening tool to exclude those with cognitive impairment with <21 being a cut-off point for PwPD. The MoCA will be used as a standardised neuropsychological test acknowledged as a valid and efficient tool for the rapid screening of global cognitive dysfunction (Nasreddine, 2005). It is used to examine diverse cognitive domains including attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation.
Measured: 15 mins
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Commonly employed to evaluate both motor and non-motor symptoms associated with PD (MDSTF, 2003). This scale consists of four main sections, each targeting a specific area of evaluation. The first part examines non-motor experiences that occur during daily living, while the second part assesses motor experiences during daily living. The third part evaluates motor examination, while the fourth part focuses on assessing complications related to therapy. To determine the severity of the symptoms, the UPDRS is scored based on a total of 195 points, where higher scores suggest increasing levels of disability.
Measured: 40 mins
Physical Activity Questionnaire Short Form (IPAQ-SF)
The International Physical Activity Questionnaire Short Form (IPAQ-SF) will be used to assesses the types of intensity of physical activity and sitting time to estimate total physical activity in MET-min/week and time spent sitting (Craig, 2003).
Measured: 5 mins
Physical activity
In addition to the IPAQ-SF and to concisely capture physical activity across a range of habitual tasks a secondary physical activity questionnaire will be used. Specifically, the physical activity questionnaire for the elderly with a reference period of 1-year will be used to understand functional household (e.g., cleaning) and community-based activities e.g., shopping (Voorips, 1991).
Measured: 5 minutes
Falls history
Falls incidence, cause, location and consequences in the previous 12-months will be assessed by a questionnaire based on recommendations (Lamb 2005, Lord 2007), that leads with the question "In the past year, have you had any fall including a slip or trip in which you lost your balance and landed on the floor or ground or lower level?" (Yardley, 2005).
Measured: 5 mins
Falls efficacy
Used to measure fear of falling in the people with PD (Yardley, 2005). This short, validated measure will assess fear of falling during both basic and demanding activities (physical and social) using a scale from 1 (Not at all concerned) to 4 (Very concerned) across 16 scenarios.
Measured: 5 mins
Musical sophistication
Goldsmiths Musical Sophistication Index (Gold-MSI): A 39-item (scored from 1 to 7) self-report designed to assess musicality across five subscales: active engagement (AE), perceptual abilities (PA), musical training (MT), singing abilities (SA), and emotional response (ER) to music (Müllensiefen, 2014). This tool evaluates and provides the detailed extent and nature of musical experiences and skills, but also provides a broader score on musicality, General Music Sophistication (GMS), ranging from 32 to 126. For this study, the scale will be used to assess if there was a relationship between an individual's general music sophistication and their adherence to the beat of the music cues. Furthermore, the relationship between an individual's subscale results and beat adherence will also be assessed.
Measured: 10 mins
System usability
System Usability Scale (SUS). This will evaluate perceptions of the app's usability, complexity, and overall satisfaction (Brooke, 2013). The SUS produces a composite score that ranges from 0 to 100, calculated by first adjusting the responses from a set of ten questions. For odd-numbered questions, the process involves subtracting one from each score, whereas for even-numbered questions, the score is subtracted from five, resulting in adjusted values that fall between 0 and 4. These adjusted values are subsequently summed together, and the total is multiplied by 2.5 to derive the final SUS score, with higher scores reflecting superior usability.
Measured: 5 mins.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start21 Nov 2024
- Primary completion19 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941779
- Sponsor's protocol ID
- CuePD
- Other IDs
- 327241, 24/PR/0684
- Acronym
- CuePD
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16267188Voorrips 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.
PubMed 1956274Tolosa 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.
PubMed 33894193Sweeney 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.
PubMed 30871253Rose 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.
PubMed 33547366Nasreddine 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.
PubMed 15817019Mullensiefen 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.
PubMed 24586929Movement 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.
PubMed 12815652Fiorente 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.
PubMed 37387705Dotov 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.
PubMed 31180717GBD 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.
PubMed 30287051Allen 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.
PubMed 23533953Wall 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.
PubMed 41984908
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CuePD: Investigating the Effect of Personalised Auditory Cueing on Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06941779
- Acronym / sponsor ID
- CuePD / CuePD
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Wearables, Personalised cueing, Gait retraining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cueing | Experimental | Device: Cueing |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CueingInertial 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. | Device | Cueing |
Primary outcome
Gait speed (m/s)
Time frame: 1 hour
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.
Step length (m)
Time frame: 1 hour
Distance between consecutive steps measured in metres (m). Measured by the smartphone/IMU via gait-based algorithms located on the lower back.
Step time variability
Time frame: 1 hour
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.
Cadence (steps/minute)
Time frame: 1 hour
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.
8 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: 15 mins
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 40 mins
Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: 5 mins
Physical activity
Time frame: 5 minutes
Falls history
Time frame: 5 mins
Falls efficacy
Time frame: 5 mins
Musical sophistication
Time frame: 10 mins
System usability
Time frame: 5 mins.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- BackgroundBrooke J. SUS: a retrospective. Journal of usability studies. 2013;8: 29-40. https://dl.acm.org/doi/10.5555/2817912.2817913
- Background: PubMed 16267188Yardley 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.
- Background: PubMed 1956274Voorrips 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.
- Background: PubMed 33894193Tolosa 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.
- Background: PubMed 30871253Sweeney 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.
- Background: PubMed 33547366Rose 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.
- Background: PubMed 15817019Nasreddine 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.
- Background: PubMed 24586929Mullensiefen 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.
- Background: PubMed 12815652Movement 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.
- Background: PubMed 37387705Fiorente 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.
- Background: PubMed 31180717Dotov 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.
- Background: PubMed 30287051GBD 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.
- Individual participant dataSharing planned: Undecided
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Effect of Physical Activity on the Course of Parkinson's Disease in Patients With Bilateral DBS-STN Stimulation.
Parkinson Disease, Deep Brain Stimulation
RecruitingPhase 2
RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
Adjustment Disorder
Not yet recruiting
Closed-Loop Therapeutic Refinement Using Local Field Potentials in Parkinson's Disease
Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cueing in people with Parkinson's Disease (PD), run by Northumbria University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (m/s) (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06941779, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.