Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2020-10-01
2022-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Hoehn & Yahr stage I (H&YI)
\- 20 Hoehn \& Yahr stage I (early disease, minimal symptoms)
Auditory Cueing
Metronome beat to step in time with
Visual Cueing
Lines on the floor to step over
tactile Cueing
Vibration to step in time with (metronome like)
Hoehn & Yahr stage II (H&YII)
\- 30 Hoehn \& Yahr stage II (mild disease, no balance issues)
Auditory Cueing
Metronome beat to step in time with
Visual Cueing
Lines on the floor to step over
tactile Cueing
Vibration to step in time with (metronome like)
Hoehn & Yahr stage III (H&YIII)
\- 30 Hoehn \& Yahr stage III (moderate disease, balance issues)
Auditory Cueing
Metronome beat to step in time with
Visual Cueing
Lines on the floor to step over
tactile Cueing
Vibration to step in time with (metronome like)
Interventions
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Auditory Cueing
Metronome beat to step in time with
Visual Cueing
Lines on the floor to step over
tactile Cueing
Vibration to step in time with (metronome like)
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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Parkinson's Foundation
OTHER
Northumbria Healthcare NHS Foundation Trust
OTHER
Northumbria University
OTHER
Responsible Party
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Principal Investigators
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Samuel Stuart, PhD
Role: PRINCIPAL_INVESTIGATOR
Northumbria University
Locations
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Oregon Health & Science University
Portland, Oregon, United States
Northumbria University
Newcastle upon Tyne, , United Kingdom
Northumbria Healthcar NHS foundation trust
North Shields, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Physiotherapy Innovation Laboratory Website
Other Identifiers
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286383
Identifier Type: OTHER
Identifier Source: secondary_id
20/LO/1036
Identifier Type: OTHER
Identifier Source: secondary_id
PF-CRA-2073
Identifier Type: -
Identifier Source: org_study_id
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