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

NCT07281794 | Recruiting

• 1 other identifier: 8543b
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease (PD); Healthy (Controls)

Keywords

DANU; Clinical Validation; Wearable Electronic Devices

Outcome Measures

Primary Outcomes (14)

• Stride Length

  (m, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Step Time

  (s, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Stride Time

  (s, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Cadence

  (steps per minute, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Ground Contact Time

  (s, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Swing Time

  (s, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Stride Velocity

  (m/s, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Gait Velocity

  (m/s, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Area of Ellipse

  (mm², mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Length of Ellipse

  (mm, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Width of Ellipse

  (mm, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Total Displacement

  (mm, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Medio-Lateral Range

  (mm, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

• Anterior-Posterior Range

  (mm, mean ± standard deviation)

  Outcomes will be obtained in one visit (Day 1).

Other Outcomes (2)

• Double Support Time

  Outcomes will be obtained in one visit (Day 1).

• Single Support Time

  Outcomes will be obtained in one visit (Day 1).

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited if they fulfill the exclaimed participation criteria and are located within the North East of England. Participants will be recruited from our existing laboratory database, word of mouth and through visiting local groups.

You may qualify if:

• 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

You may not qualify if:

• 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.)
• 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.
• 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.)

Sponsors & Collaborators

• Northumbria University: lead
• DANU Sports Ltd: collaborator

Study Sites (2)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, United Kingdom

RECRUITING

Northumbria University

Newcastle upon Tyne, United Kingdom

ENROLLING BY INVITATION

Related Links

• DANU Medical Website: Study Collaborator and Smart Sock System.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Rodrigo Vitorio, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella R Gatti, BSc

CONTACT

01912273343; gabriella.gatti@northumbria.ac.uk

Rodrigo Vitorio, PhD

CONTACT

01912273343; rodrigo.vitorio@northumbria.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Research Student

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: December 15, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)