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| ID | Type | Description | Link |
|---|---|---|---|
| 286383 | Other Identifier | IRAS | |
| 20/LO/1036 | Other Identifier | NHS Research Ethics Committee Reference |
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| Name | Class |
|---|---|
| Parkinson's Foundation | OTHER |
| Northumbria Healthcare NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory Cueing | Other | Metronome beat to step in time with |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stride Length (m) | Change in stride length with cueing | immediately after intervention |
| Change in Gait Speed (m/s) | Change in speed of walking with cueing |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Stuart, PhD | Contact | 01912233343 | sam.stuart@northumbria.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Samuel Stuart, PhD | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Active, not recruiting | Portland | Oregon | 97239 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40652355 | Derived | 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. | |
| 36395190 | Derived |
| Label | URL |
|---|---|
| Physiotherapy Innovation Laboratory Website | View source |
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Access to the datasets can be obtained by contacting the principle investigator.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 17, 2020 | Mar 31, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Visual Cueing | Other | Lines on the floor to step over |
|
| tactile Cueing | Other | Vibration to step in time with (metronome like) |
|
| immediately after intervention |
| Change in Stride Time (s) | Change in time taken to complete a stride when walking with cues | immediately after intervention |
| Change in Gait Variability (SD) | Change in variability (standard deviation; SD) of gait when walking with cues | immediately after intervention |
| Northumbria University |
| Recruiting |
| Newcastle upon Tyne |
| NE7 7XA |
| United Kingdom |
|
| Northumbria Healthcar NHS foundation trust | Recruiting | North Shields | NE29 8NH | United Kingdom |
|
| 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |