Objective Mobility Assessment Using Wearable Technology for Clinical Application in Parkinson's Disease: From Validation to Fall Prediction

February 11, 2026 updated by: GabriellaGatti, Northumbria University
The main objective of this observational trial is to explore the validity and reliability of DANU smart socks when used for mobility assessments in people with Parkinson's. Using a series of laboratory gold standard equipment, this project aims to compare the metrics observed by DANU to the reference standards. No intervention is included. Specifically, this study will explore metrics relating to walking (gait) and balance of a Parkinson's cohort through a series of motor tasks. Moreover, this study seeks to investigate the clinical validity of DANU outcome metrics exploring relationships with clinical scales, fall history and prospective falls.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background:

Mobility impairments are common in Parkinson's disease (PD) and increase the risk of falling. Data derived from wearable inertial measurement units can provide useful information regarding gait in different situations and environments, which may help to identify those at risk of falling. However, rigorous testing is required to evaluate whether new devices are fit for purpose. DANU Smart Socks are a multi-modal system for movement analysis, containing 15 silicone based capacitive pressure sensors and an IMU pod, with tri-axal accelerometers, gyroscope and magnetometers, currently at use within a sporting context. Potential has been highlighted for clinical use in people with Parkinson's (PwP). This study aims to evaluate the validity, reliability and usability of the DANU Sport System in PwP for balance and gait assessment. The V3+ framework for determining fit-for-purpose biometric monitoring devices will be employed, evaluating verification, usability, analytical and clinical validation.

Methods:

Institutional ethics have been obtained (Project ID: 8543). Utilising a a repeated measures observational design, participants will be asked to attend two visits 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. Following this, concurrent data collection will occur throughout a battery of motor tasks to observe gait/balance metrics. Laboratory references employed include Axivity AX6, Vicon 3D Motion Capture, APDM Mobility Lab, GAITRite and AMTI Force Plates. Mobility assessments include a 2-Minute Walk Test, 3 walkway trials, a Timed Up and Go and a series of 2-Minute Balance tasks.

Visit 2: Participants attend a second visit to repeat the mobility assessment previously detailed utilizing DANU Smart Socks and APDM Mobility Lab systems to explore test-retest reliability.

Wearable device (DANU) validity and reliability will be examined using intra-class correlation coefficients and Bland-Altman plots to compare to laboratory reference standards. Moreover time series plots will be employed to evaluate the raw data agreement.

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
        • Recruiting
        • Northumbria University
        • Sub-Investigator:
          • Alan Godfrey, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodrigo Vitorio, PhD
        • Sub-Investigator:
          • Rosie Morris, PhD
        • Sub-Investigator:
          • Samuel Stuart, PhD
        • Sub-Investigator:
          • Gabriella R Gatti, Bsc

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

No

Sampling Method

Non-Probability Sample

Study Population

Within laboratory testing, 60 people with Parkinson's (H&Y I-III) are aimed to be recruited from the North East region of England.

Description

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.

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)

People with a clinical diagnosis of Parkinson's Disease will be recruited to participate within the study. All participants must fit within the described eligibility criteria.

Within the verification and analytical validation phase 30 people with Parkinson's will be recruited and within clinical validation 60 individuals will be recruited.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stride Length
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(m, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Step Time
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(s, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Stride Time
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(s, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Cadence
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(steps per minute, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Ground Contact Time
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(s, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Swing Time
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(s, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Stride Velocity
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(m/s, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Gait Velocity
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(m/s, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Area of Ellipse
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm², mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Length of Ellipse
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Width of Ellipse
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Total Displacement
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Medio-Lateral Range
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Anterior-Posterior Range
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(mm, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double Support Time
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(s, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
Single Support Time
Time Frame: Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
(s, mean ± standard deviation)
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

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

  • 8543a

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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