Brain Activity During Gait in Parkinson's
BARC-PD
Brain Activity Response to Cues During Gait in Parkinson's
3 other identifiers
observational
80
2 countries
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2020
Typical duration for all trials
3 active sites
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
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 6, 2021
CompletedFirst Posted
Study publicly available on registry
April 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedApril 28, 2021
April 1, 2021
2.2 years
April 6, 2021
April 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
immediately after intervention
Secondary Outcomes (4)
Change in Stride Length (m)
immediately after intervention
Change in Gait Speed (m/s)
immediately after intervention
Change in Stride Time (s)
immediately after intervention
Change in Gait Variability (SD)
immediately after intervention
Study Arms (3)
Hoehn & Yahr stage I (H&YI)
\- 20 Hoehn \& Yahr stage I (early disease, minimal symptoms)
Hoehn & Yahr stage II (H&YII)
\- 30 Hoehn \& Yahr stage II (mild disease, no balance issues)
Hoehn & Yahr stage III (H&YIII)
\- 30 Hoehn \& Yahr stage III (moderate disease, balance issues)
Interventions
Metronome beat to step in time with
Lines on the floor to step over
Vibration to step in time with (metronome like)
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northumbria Universitylead
- Parkinson's Foundationcollaborator
- Northumbria Healthcare NHS Foundation Trustcollaborator
Study Sites (3)
Oregon Health & Science University
Portland, Oregon, 97239, United States
Northumbria University
Newcastle upon Tyne, NE7 7XA, United Kingdom
Northumbria Healthcar NHS foundation trust
North Shields, NE29 8NH, United Kingdom
Related Publications (1)
Vitorio 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.
PMID: 36395190DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Stuart, PhD
Northumbria University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2021
First Posted
April 28, 2021
Study Start
October 1, 2020
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
April 28, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
Access to the datasets can be obtained by contacting the principle investigator.