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

February 11, 2026 updated by: GabriellaGatti, Northumbria University
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Newcastle upon Tyne, United Kingdom
        • Enrolling by invitation
        • Northumbria University
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom
        • Recruiting
        • Northumbria University
        • Sub-Investigator:
          • Alan Godfrey, PhD
        • Contact:
        • Contact:
          • Rodrigo Vitorio, PhD
          • Phone Number: 01912156078
        • Sub-Investigator:
          • Gabriella Gatti, BSc
        • Principal Investigator:
          • Rodrigo Vitorio, PhD
        • Sub-Investigator:
          • Rosie Morris, PhD
        • Sub-Investigator:
          • Samuel Stuart, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stride Length
Time Frame: Outcomes will be obtained in one visit (Day 1).
(m, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Step Time
Time Frame: Outcomes will be obtained in one visit (Day 1).
(s, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Stride Time
Time Frame: Outcomes will be obtained in one visit (Day 1).
(s, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Cadence
Time Frame: Outcomes will be obtained in one visit (Day 1).
(steps per minute, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Ground Contact Time
Time Frame: Outcomes will be obtained in one visit (Day 1).
(s, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Swing Time
Time Frame: Outcomes will be obtained in one visit (Day 1).
(s, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Stride Velocity
Time Frame: Outcomes will be obtained in one visit (Day 1).
(m/s, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Gait Velocity
Time Frame: Outcomes will be obtained in one visit (Day 1).
(m/s, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Area of Ellipse
Time Frame: Outcomes will be obtained in one visit (Day 1).
(mm², mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Length of Ellipse
Time Frame: Outcomes will be obtained in one visit (Day 1).
(mm, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Width of Ellipse
Time Frame: Outcomes will be obtained in one visit (Day 1).
(mm, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Total Displacement
Time Frame: Outcomes will be obtained in one visit (Day 1).
(mm, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Medio-Lateral Range
Time Frame: Outcomes will be obtained in one visit (Day 1).
(mm, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Anterior-Posterior Range
Time Frame: Outcomes will be obtained in one visit (Day 1).
(mm, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double Support Time
Time Frame: Outcomes will be obtained in one visit (Day 1).
(s, mean ± standard deviation)
Outcomes will be obtained in one visit (Day 1).
Single Support Time
Time Frame: Outcomes will be obtained in one visit (Day 1).
(s, mean ± standard deviation
Outcomes will be obtained in one visit (Day 1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Collaborators

DANU Sports Ltd

Investigators

  • Principal Investigator: Rodrigo Vitorio, PhD, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 16, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8543b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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