Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease
NCT ID: NCT07281794
Last Updated: 2025-12-22
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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ENROLLING_BY_INVITATION
60 participants
OBSERVATIONAL
2025-08-08
2027-09-30
Brief Summary
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Detailed Description
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Institutional ethics have been obtained (Project ID: 8543). Utilising an observational design, participants will be asked to attend one visit to Northumbria University, Newcastle Upon Tyne.
Visit 1: Participants will complete a series of clinical and cognitive measures including the Movement Disorders Society's-Unified Parkinson's Disease Rating Scale, Montreal Cognitive Assessment, Freezing of Gait Questionnaire and Falls Efficacy Scale to act as descriptive measures. Following this, the investigators will conduct a concurrent data collection throughout a battery of motor tasks. The DANU system will be used alongside APDM Mobility Lab throughout the full duration of data collection. Mobility assessments include a 2-Minute Walk Test, 3 walkway trials, a Timed Up and Go and a series of 2-Minute Balance tasks.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Parkinson's Disease (PD)
Participants with a clinical diagnosis of Parkinson's Disease meeting the described eligibility criteria will be recruited to take part within this study. The aim is to recruit 60 people with Parkinson's.
No interventions assigned to this group
Healthy Control (HC)
Aged-matched (over 50 years old) healthy controls who meet the described eligibility criteria will be recruited to participate in this study. The aim is to recruit 60 participants.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able to attend Northumbria University, Newcastle Upon Tyne for study visits.
* Able to walk and stand unassisted for a minimum of 2-minutes.
* Aged 50 years old or over
* Ability to attend Northumbria University, Newcastle Upon Tyne for study visits.
* Aged 50 years old or over.
* Able to walk and stand unassisted for a minimum of 2-minutes.
Exclusion Criteria
* Unable to walk or stand unaided.
* Montreal Cognitive Assessment (MoCA) score \< 21
* Significant issues unrelated to PD that may affect gait (e.g., musculoskeletal issues, back pain, recent surgery etc.)
* History of neurological disorders (e.g. Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)
* Significant issues that may affect walking (e.g., musculoskeletal issues, back pain, recent surgery etc.)
50 Years
ALL
Yes
Sponsors
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DANU Sports Ltd
UNKNOWN
Northumbria University
OTHER
Responsible Party
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GabriellaGatti
Postgraduate Research Student
Principal Investigators
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Rodrigo Vitorio, PhD
Role: PRINCIPAL_INVESTIGATOR
Northumbria University
Locations
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Northumbria University
Newcastle upon Tyne, , United Kingdom
Countries
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Related Links
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DANU Medical Website: Study Collaborator and Smart Sock System.
Other Identifiers
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8543b
Identifier Type: -
Identifier Source: org_study_id