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Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Health checks and monitoring — no treatment given
Type of study: Observational (no treatment given)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Not specified by the sponsor
How long the study runs: Study runs about 25 months (dates as stated)
About the drug or intervention: Not specified by the sponsor
Patient visit burden: Not specified by the sponsor

Type of study: Observing health over time
Ages: 50 Years and over
Who: All
Number of participants: 60
Started: 2025-08-08
Last checked: 2025-09

Plain English Summary

What is this study?

• Testing a new treatment for parkinson disease (pd)
• Clinical study - 60 participants
• This observational study aims to explore the use of the DANU Smart Socks for gait and balance assessment in people with Parkinson's (PwP)

Who can take part?

• Ages 50 Years and over
• Diagnosed with parkinson disease (pd)

Where?

• Newcastle upon Tyne - Northumbria University
• Newcastle upon Tyne - Northumbria University

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Methods: 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.

Parkinson Disease (PD)Healthy (Controls)

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 50 Years and over
Who can join: All genders

What the study is looking for

✓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

Who cannot take part

✗History of neurological disorders other than PD (e.g., Huntington's disease, stroke, traumatic brain injury,...
✗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:

See the full 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 Is This Study? (2 UK sites)

Northumbria University

Newcastle upon Tyne, United Kingdom

Recruiting

Site contact (verified)

Rodrigo Vitorio, PhDPrincipal Investigator

Gabriella Gatti, BSc01912156078 gabriella.gatti@northumbria.ac.uk

Rodrigo Vitorio, PhD01912156078

Northumbria University

Newcastle upon Tyne, United Kingdom

ENROLLING_BY_INVITATION

Hospital R&D contact (matched)

Research and Development

researchanddevelopment@nhct.nhs.uk 0191 2934087

How to Get in Touch

Gabriella R Gatti, BSc

Sponsor contact

CONTACT

01912273343 gabriella.gatti@northumbria.ac.uk

Rodrigo Vitorio, PhD

Sponsor contact

CONTACT

01912273343 rodrigo.vitorio@northumbria.ac.uk

Data sourced from ClinicalTrials.gov · Last verified: 2025-09