Parkinson DiseaseBARC-PDNCT04863560
Brain Activity During Gait in Parkinson's
An observational study of Parkinson Disease, run by Northumbria University at 3 sites in 2 countries.
Trial summary
Lay Summary: Walking problems, such as slow and short steps, are very common in Parkinson's disease and lead to increased falls risk, as well as reduced mobility and quality of life. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Auditory Cueing, Visual Cueing and tactile Cueing
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Oct 2020to 30 Nov 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve 80 participants with PD, who will be split into groups dependent on the severity of their disease (classified with the Hoehn and Yahr (H\&Y) scale); n=20 H\&Y stage I (early disease, minimal symptoms); n=30 H\&Y stage II (mild disease, no balance issues); n=30 H\&Y stage III (moderate disease, balance issues). Within the H\&Y stage II and III groups, we will also ensure recruitment of a sub-group of n=15 individuals who self-report FOG within each group (n=30 total with FOG), which will provide a sub-group for further data analysis. We will limit FOG sub-group recruitment to these groups as we do not expect any individuals with FOG to be in H\&Y stage I.
Who may be able to join
- Clinical diagnosis of Parkinson's by a movement disorder specialist according to United Kingdom (UK) brain bank criteria
- Hoehn \& Yahr (H\&Y) stage I-III
- Aged >50 years
- Able to walk and stand unaided
- Adequate hearing (as evaluated by the whisper test; stand 2m behind subject and whisper a 2 syllable word, subject repeats word) and vision capabilities (as measured using a Snellen chart - 6/18-6/12).
- Stable medication for the past 1 month and anticipated over a period of 6 months
Who cannot join
- Psychiatric co-morbidity (e.g., major depressive disorder as determined by Geriatric Depression Scale - short form (GDS-15); <10 [26])
- Clinical diagnosis of dementia or other severe cognitive impairment (Montreal cognitive assessment <21 [27])
- History of stroke, traumatic brain injury or other neurological disorders (other than PD, for the PD group)
- Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
- 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
- Interfering therapy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites, 2 recruiting
- Recruiting
Northumbria University
Newcastle upon Tyne, NE7 7XA
Samuel Stuart, PhD, 01912233343, sam.stuart@northumbria.ac.uk
Rosie Morris, PhD, rosie.e.morris@northumbria.ac.uk
- Recruiting
Northumbria Healthcar NHS foundation trust
North Shields, NE29 8NH
Richard Walker, 01912932709, richard.walker@northumbria-healthcare.nhs.uk
United States1 site
- Active, not recruiting
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Brain Activity Response to Cues During Gait in Parkinson's
Lay Summary:
Walking problems, such as slow and short steps, are very common in Parkinson's disease and lead to increased falls risk, as well as reduced mobility and quality of life. Walking issues are difficult to treat as medication interventions do not restore walking ability in people with Parkinson's, therefore physiotherapy approaches are used to help improve walking. Various physiotherapy strategies have been used, such as internal (thinking about bigger steps) or external prompts. External prompts include auditory (a metronome beat to step in time to), visual (lines to step over on the floor) and tactile (metronome-like vibration to step with) prompts that are very commonly used to improve walking in Parkinson's. However, the reason why walking improves in people with Parkinson's with these physiotherapy strategies is unknown, which has led to not all patients benefiting and only short-term walking improvements being seen.
Read more
The main issues are that it is unclear if these various internal or external prompt strategies are effective with the progression of Parkinson's disease, and it is unknown which type of strategy is most effective at different disease stages or with more severe walking impairment, such as freezing (the inability to progress walking for short periods despite wanting to do so). Being able to use specific brain regions to pay attention to different internal or external prompts has been suggested to be the reason why people with Parkinson's can overcome their walking problems, but this has not been tested. Therefore, this study will use state-of-the-art digital technology to measure walking and brain activity changes with different internal and external prompts. The investigators think that the walking improvement with different prompt strategies relies on the ability to activate specific brain regions, and that brain region activity in response to internal or external prompts will change at different stages of Parkinson's disease.
Ultimately, understanding the reasons why people benefit from these physiotherapy strategies and who benefits most from specific strategies will enable clinicians to provide more timely and efficient treatment for people with Parkinson's, and to develop more effective strategies to further improve walking.
- Conditions
- Parkinson Disease
- Being tested
- Auditory Cueing, Visual Cueing, tactile Cueing
- Keywords
- Parkison's disease, Gait, functional near infrared spectroscopy, electroencephalography, Inertial Sensors, Brain activity, Cueing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory CueingOther
Metronome beat to step in time with
Visual CueingOther
Lines on the floor to step over
tactile CueingOther
Vibration to step in time with (metronome like)
| Study group | Role | What they receive |
|---|---|---|
| Hoehn & Yahr stage I (H&YI) | - 20 Hoehn \& Yahr stage I (early disease, minimal symptoms) Receives: Other: Auditory Cueing; Other: Visual Cueing; Other: tactile Cueing | |
| Hoehn & Yahr stage II (H&YII) | - 30 Hoehn \& Yahr stage II (mild disease, no balance issues) Receives: Other: Auditory Cueing; Other: Visual Cueing; Other: tactile Cueing | |
| Hoehn & Yahr stage III (H&YIII) | - 30 Hoehn \& Yahr stage III (moderate disease, balance issues) Receives: Other: Auditory Cueing; Other: Visual Cueing; Other: tactile Cueing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cortical oxygenated hemoglobin (HbO2) signal during walking
Change in cortical oxygenated hemoglobin (HbO2) measured while walking with cueing, which will be quantified with a wireless functional near infrared spectroscopy (fNIRS) system
Measured: immediately after intervention
Change in cortical power spectral densities during walking
Change in cortical power spectral densities of EEG signals from cortex with cueing, which will be quantified with a mobile electroencephalography (EEG) system
Measured: immediately after intervention
Secondary outcomes (4)
Change in Stride Length (m)
Change in stride length with cueing
Measured: immediately after intervention
Change in Gait Speed (m/s)
Change in speed of walking with cueing
Measured: immediately after intervention
Change in Stride Time (s)
Change in time taken to complete a stride when walking with cues
Measured: immediately after intervention
Change in Gait Variability (SD)
Change in variability (standard deviation; SD) of gait when walking with cues
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Oct 2020
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Foundation, Northumbria Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Samuel Stuart, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863560
- Sponsor's protocol ID
- PF-CRA-2073
- Other IDs
- 286383, 20/LO/1036
- Acronym
- BARC-PD
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to the datasets can be obtained by contacting the principle investigator.
Publications
Vitorio R, Morris R, Graham L, Das J, Walker R, McDonald C, Mancini M, Stuart S. Effects of Internal and External Cues on Brain Activity and Gait in Parkinson's Disease: Findings From BARC-PD. Neurorehabil Neural Repair. 2025 Oct;39(10):826-838. doi: 10.1177/15459683251351876. Epub 2025 Jul 13.
PubMed 40652355Vitorio R, Morris R, Das J, Walker R, Mancini M, Stuart S. Brain activity response to cues during gait in Parkinson's disease: A study protocol. PLoS One. 2022 Nov 17;17(11):e0275894. doi: 10.1371/journal.pone.0275894. eCollection 2022.
PubMed 36395190
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activity Response to Cues During Gait in Parkinson's
- ClinicalTrials.gov ID
- NCT04863560
- Acronym / sponsor ID
- BARC-PD / PF-CRA-2073
- Conditions
- Parkinson Disease
- Keywords
- Parkison's disease, Gait, functional near infrared spectroscopy, electroencephalography, Inertial Sensors, Brain activity, Cueing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Parkinson's Foundation, Northumbria Healthcare NHS Foundation Trust
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 28 Apr 2021 (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.
Lay Summary:
Walking problems, such as slow and short steps, are very common in Parkinson's disease and lead to increased falls risk, as well as reduced mobility and quality of life. Walking issues are difficult to treat as medication interventions do not restore walking ability in people with Parkinson's, therefore physiotherapy approaches are used to help improve walking. Various physiotherapy strategies have been used, such as internal (thinking about bigger steps) or external prompts. External prompts include auditory (a metronome beat to step in time to), visual (lines to step over on the floor) and tactile (metronome-like vibration to step with) prompts that are very commonly used to improve walking in Parkinson's. However, the reason why walking improves in people with Parkinson's with these physiotherapy strategies is unknown, which has led to not all patients benefiting and only short-term walking improvements being seen.
The main issues are that it is unclear if these various internal or external prompt strategies are effective with the progression of Parkinson's disease, and it is unknown which type of strategy is most effective at different disease stages or with more severe walking impairment, such as freezing (the inability to progress walking for short periods despite wanting to do so). Being able to use specific brain regions to pay attention to different internal or external prompts has been suggested to be the reason why people with Parkinson's can overcome their walking problems, but this has not been tested. Therefore, this study will use state-of-the-art digital technology to measure walking and brain activity changes with different internal and external prompts. The investigators think that the walking improvement with different prompt strategies relies on the ability to activate specific brain regions, and that brain region activity in response to internal or external prompts will change at different stages of Parkinson's disease.
Ultimately, understanding the reasons why people benefit from these physiotherapy strategies and who benefits most from specific strategies will enable clinicians to provide more timely and efficient treatment for people with Parkinson's, and to develop more effective strategies to further improve walking.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hoehn & Yahr stage I (H&YI) | – | Other: Auditory Cueing, Other: Visual Cueing, Other: tactile Cueing- 20 Hoehn \& Yahr stage I (early disease, minimal symptoms) |
| Hoehn & Yahr stage II (H&YII) | – | Other: Auditory Cueing, Other: Visual Cueing, Other: tactile Cueing- 30 Hoehn \& Yahr stage II (mild disease, no balance issues) |
| Hoehn & Yahr stage III (H&YIII) | – | Other: Auditory Cueing, Other: Visual Cueing, Other: tactile Cueing- 30 Hoehn \& Yahr stage III (moderate disease, balance issues) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve 80 participants with PD, who will be split into groups dependent on the severity of their disease (classified with the Hoehn and Yahr (H\&Y) scale); n=20 H\&Y stage I (early disease, minimal symptoms); n=30 H\&Y stage II (mild disease, no balance issues); n=30 H\&Y stage III (moderate disease, balance issues). Within the H\&Y stage II and III groups, we will also ensure recruitment of a sub-group of n=15 individuals who self-report FOG within each group (n=30 total with FOG), which will provide a sub-group for further data analysis. We will limit FOG sub-group recruitment to these groups as we do not expect any individuals with FOG to be in H\&Y stage I.
Key inclusion criteria (6 listed)
- Clinical diagnosis of Parkinson's by a movement disorder specialist according to United Kingdom (UK) brain bank criteria
- Hoehn \& Yahr (H\&Y) stage I-III
- Aged >50 years
- Able to walk and stand unaided
- Adequate hearing (as evaluated by the whisper test; stand 2m behind subject and whisper a 2 syllable word, subject repeats word) and vision capabilities (as measured using a Snellen chart - 6/18-6/12).
Key exclusion criteria (7 listed)
- Psychiatric co-morbidity (e.g., major depressive disorder as determined by Geriatric Depression Scale - short form (GDS-15); <10 [26])
- Clinical diagnosis of dementia or other severe cognitive impairment (Montreal cognitive assessment <21 [27])
- History of stroke, traumatic brain injury or other neurological disorders (other than PD, for the PD group)
- Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
- Unstable medical condition including cardio-vascular instability in the past 6 months
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 |
|---|---|---|
| Auditory CueingMetronome beat to step in time with | Other | Hoehn & Yahr stage I (H&YI), Hoehn & Yahr stage II (H&YII), Hoehn & Yahr stage III (H&YIII) |
| Visual CueingLines on the floor to step over | Other | Hoehn & Yahr stage I (H&YI), Hoehn & Yahr stage II (H&YII), Hoehn & Yahr stage III (H&YIII) |
| tactile CueingVibration to step in time with (metronome like) | Other | Hoehn & Yahr stage I (H&YI), Hoehn & Yahr stage II (H&YII), Hoehn & Yahr stage III (H&YIII) |
Primary outcome
Change in cortical oxygenated hemoglobin (HbO2) signal during walking
Time frame: immediately after intervention
Change in cortical oxygenated hemoglobin (HbO2) measured while walking with cueing, which will be quantified with a wireless functional near infrared spectroscopy (fNIRS) system
Change in cortical power spectral densities during walking
Time frame: immediately after intervention
Change in cortical power spectral densities of EEG signals from cortex with cueing, which will be quantified with a mobile electroencephalography (EEG) system
4 secondary outcomes
Change in Stride Length (m)
Time frame: immediately after intervention
Change in Gait Speed (m/s)
Time frame: immediately after intervention
Change in Stride Time (s)
Time frame: immediately after intervention
Change in Gait Variability (SD)
Time frame: immediately after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 40652355Vitorio R, Morris R, Graham L, Das J, Walker R, McDonald C, Mancini M, Stuart S. Effects of Internal and External Cues on Brain Activity and Gait in Parkinson's Disease: Findings From BARC-PD. Neurorehabil Neural Repair. 2025 Oct;39(10):826-838. doi: 10.1177/15459683251351876. Epub 2025 Jul 13.
- Derived from this study: PubMed 36395190Vitorio R, Morris R, Das J, Walker R, Mancini M, Stuart S. Brain activity response to cues during gait in Parkinson's disease: A study protocol. PLoS One. 2022 Nov 17;17(11):e0275894. doi: 10.1371/journal.pone.0275894. eCollection 2022.
- Physiotherapy Innovation Laboratory WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Access to the datasets can be obtained by contacting the principle investigator.
Related trials for Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
Parkinsons Disease (PD)
RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Parkinson's Disease, Dementia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
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.
Samuel Stuart, PhD principal investigator
Northumbria University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Northumbria University at 3 sites in 2 countries.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Stuart, PhD (01912233343, sam.stuart@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cortical oxygenated hemoglobin (HbO2) signal during walking (time frame: immediately after intervention). The study lists 2 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 NCT04863560, which also lists 2 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 28 Apr 2021.