Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07281794

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northumbria University, Newcastle upon Tyne, Tyne and Wear, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. Stride Length

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

    (m, mean ± standard deviation)

  2. Step Time

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

    (s, mean ± standard deviation)

  3. Stride Time

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

    (s, mean ± standard deviation)

  4. Cadence

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

    (steps per minute, mean ± standard deviation)

  5. Ground Contact Time

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

    (s, mean ± standard deviation)

  6. Swing Time

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

    (s, mean ± standard deviation)

  7. Stride Velocity

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

    (m/s, mean ± standard deviation)

  8. Gait Velocity

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

    (m/s, mean ± standard deviation)

  9. Area of Ellipse

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

    (mm², mean ± standard deviation)

  10. Length of Ellipse

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

    (mm, mean ± standard deviation)

  11. Width of Ellipse

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

    (mm, mean ± standard deviation)

  12. Total Displacement

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

    (mm, mean ± standard deviation)

  13. Medio-Lateral Range

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

    (mm, mean ± standard deviation)

  14. Anterior-Posterior Range

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

    (mm, mean ± standard deviation)

Other outcomes

  1. Double Support Time

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

    (s, mean ± standard deviation)

  2. Single Support Time

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

    (s, mean ± standard deviation

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella R Gatti, BSc

CONTACT

[email protected]

01912273343

Rodrigo Vitorio, PhD

CONTACT

[email protected]

01912273343

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • DANU Sports Ltd

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 15, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.