Using DANU smart socks to measure walking, balance, and fall risk in Parkinson's
Objective Mobility Assessment Using Wearable Technology for Clinical Application in Parkinson's Disease: From Validation to Fall Prediction
This project will test whether DANU smart socks can accurately measure gait and balance and help predict falls in people with Parkinson's.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Northumbria University Academic / other |
| Locations | 1 site (Newcastle upon Tyne) |
| Trial ID | NCT07281755 on ClinicalTrials.gov |
What this trial studies
This observational, repeated-measures project will compare metrics from DANU smart socks to laboratory gold-standard gait and balance equipment using the V3+ framework for biometric device validation. Participants with Parkinson's will attend two visits at Northumbria University to complete a series of motor tasks while wearing the socks, alongside clinical scales such as the MDS-UPDRS, MoCA, Freezing of Gait Questionnaire, and Falls Efficacy Scale. The study will examine analytical validity, reliability, usability, and relationships between DANU outcomes, clinical scores, past fall history, and prospective falls. Results will determine whether the sock-derived measures match reference standards and whether they relate to clinical measures and future fall risk.
Who should consider this trial
Good fit: Adults with a clinical diagnosis of Parkinson's disease (Hoehn & Yahr stages I–III) who can stand and walk unassisted for at least two minutes, have MoCA ≥21, and can attend two visits to Northumbria University are eligible.
Not a fit: People with more advanced Parkinson's (Hoehn & Yahr IV–V), significant cognitive impairment (MoCA <21), other neurological disorders, or recent lower-limb injury are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could provide objective, wearable measures of gait and balance to help identify people with Parkinson's who are at higher risk of falling.
How similar studies have performed: Wearable inertial sensors and pressure-sensing insoles have shown promise for gait measurement and fall risk prediction, but DANU smart socks are a relatively new form factor that requires formal validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of Parkinson's by a movement disorder specialist according to UK brain bank criteria. * Hoehn \& Yahr stages I-III * Able to attend Northumbria University, Newcastle Upon Tyne for study visits * Able to walk and stand unassisted for a minimum of 2-minutes Exclusion Criteria: * History of neurological disorders other than PD (e.g., Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.) * Montreal Cognitive Assessment (MoCA) score \< 21 * Injury to the lower extremities within the past 6-weeks.
Where this trial is running
Newcastle upon Tyne
- Northumbria University — Newcastle upon Tyne, United Kingdom (Recruiting)
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.