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

NCT07281755 | Recruiting

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

Brief Summary

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.

Conditions

Parkinson Disease(PD)

Keywords

DANU; Wearable Electronic Devices; Gait Analysis; Validity and Reliability; Mobility Assessment; Smart Socks

Outcome Measures

Primary Outcomes (14)

• Stride Length

  (m, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Step Time

  (s, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Stride Time

  (s, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Cadence

  (steps per minute, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Ground Contact Time

  (s, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Swing Time

  (s, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Stride Velocity

  (m/s, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Gait Velocity

  (m/s, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Area of Ellipse

  (mm², mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Length of Ellipse

  (mm, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Width of Ellipse

  (mm, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Total Displacement

  (mm, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Medio-Lateral Range

  (mm, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Anterior-Posterior Range

  (mm, mean ± standard deviation)

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

Other Outcomes (2)

• Double Support Time

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

• Single Support Time

  Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).

Study Arms (1)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

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.)
• Montreal Cognitive Assessment (MoCA) score \< 21
• Injury to the lower extremities within the past 6-weeks.

Sponsors & Collaborators

• Northumbria University: lead
• DANU Sports Ltd: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, United Kingdom

RECRUITING

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: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Researcher

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 (1)