NCT07281794 Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease
| NCT ID | NCT07281794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northumbria University |
| Condition | Parkinson Disease (PD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-08-08 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This observational study aims to explore the use of the DANU Smart Socks for gait and balance assessment in people with Parkinson's (PwP). The study will compare walking and balance outcomes produced by DANU from people with Parkinson's (PwP) and a group of healthy individuals of similar age. The project aims to investigate if the gait and balance data collected are linked to measures of Parkinson's symptoms such as disease progression and cognitive abilities. Gait and balance outcomes will be obtained through one observational laboratory visit.
Eligibility Criteria
Parkinson's Group Inclusion Criteria:- Clinical diagnosis of Parkinson's by a movement disorder specialist according to UK brain bank criteria. * PD stages I-III (Hoehn and Yahr Rating Scale) * 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 Parkinson's Group Exclusion Criteria: * History of neurological disorders other than PD (e.g., Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.) * 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.) Healthy Control Inclusion Criteria: * 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. Healthy Control Exclusion Criteria: * 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.)
Contact & Investigator
Rodrigo Vitorio, PhD
PRINCIPAL INVESTIGATOR
Northumbria University
Frequently Asked Questions
Who can join the NCT07281794 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Parkinson Disease (PD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07281794 currently recruiting?
Yes, NCT07281794 is actively recruiting participants. Contact the research team at gabriella.gatti@northumbria.ac.uk for enrollment information.
Where is the NCT07281794 trial being conducted?
This trial is being conducted at Newcastle upon Tyne, United Kingdom, Newcastle upon Tyne, United Kingdom.
Who is sponsoring the NCT07281794 clinical trial?
NCT07281794 is sponsored by Northumbria University. The principal investigator is Rodrigo Vitorio, PhD at Northumbria University. The trial plans to enroll 60 participants.
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