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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorNorthumbria University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Parkinson's Disease (PD)

Trial outcomes

Primary outcomes

1

Stride Length

(m, mean ± standard deviation)

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

Step Time

(s, mean ± standard deviation)

Time frame
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
3

Stride Time

(s, mean ± standard deviation)

Time frame
Outcomes will be obtained on Visit 1 (Day 1) and Visit 2 (Day 8).
4

Cadence

(steps per minute, mean ± standard deviation)

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

Secondary outcomes

Other outcomes

1

Double Support Time

(s, mean ± standard deviation)

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

Single Support Time

(s, mean ± standard deviation)

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northumbria University

Lead sponsor

DANU Sports Ltd

Collaborator