DANU Smart Socks to measure walking and balance in Parkinson's
Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease
This project will test whether DANU Smart Socks can measure walking and balance in people with Parkinson's and compare their results with healthy adults of similar age.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Northumbria University Academic / other |
| Locations | 2 sites (Newcastle upon Tyne, Tyne and Wear and 1 other locations) |
| Trial ID | NCT07281794 on ClinicalTrials.gov |
What this trial studies
This is an observational, single-visit study at Northumbria University comparing people with Parkinson's (Hoehn and Yahr I–III) to age-matched healthy controls. Participants complete clinical and cognitive tests (including MDS-UPDRS and MoCA) and then perform a battery of mobility tasks while data are collected concurrently by the DANU Smart Socks and APDM Mobility Lab. Mobility tasks include a 2-minute walk, multiple walkway trials, Timed Up and Go, and 2-minute balance tasks. The goal is to see whether gait and balance metrics from the DANU system relate to Parkinson's symptoms, disease stage, and cognitive scores.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 or older with a clinical Parkinson's diagnosis (Hoehn and Yahr stages I–III), who can walk and stand unassisted for at least two minutes and can attend a single visit at Northumbria University.
Not a fit: People with advanced Parkinson's beyond Hoehn and Yahr stage III, significant cognitive impairment (MoCA <21), inability to walk or stand unaided, or other neurological/musculoskeletal conditions affecting gait are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could provide a simple wearable tool to help clinicians monitor gait and balance changes in people with Parkinson's.
How similar studies have performed: Wearable inertial sensor systems and lab platforms like APDM Mobility Lab have shown promise for quantifying gait and balance in Parkinson's, but the DANU Smart Socks are relatively new and require clinical validation.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Newcastle upon Tyne, Tyne and Wear and 1 other locations
- Northumbria University — Newcastle upon Tyne, Tyne and Wear, United Kingdom (Recruiting)
- Northumbria University — Newcastle upon Tyne, United Kingdom (Enrolling_by_invitation)
Study contacts
- Principal investigator: Rodrigo Vitorio, PhD — Northumbria University
- Study coordinator: Gabriella R Gatti, BSc
- Email: gabriella.gatti@northumbria.ac.uk
- Phone: 01912273343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.