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 volunteersQualifiers
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
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Stride Length
(m, mean ± standard deviation)
Step Time
(s, mean ± standard deviation)
Stride Time
(s, mean ± standard deviation)
Cadence
(steps per minute, mean ± standard deviation)
Other outcomes
Double Support Time
(s, mean ± standard deviation)
Single Support Time
(s, mean ± standard deviation)
Sponsors and contacts
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Northumbria University
Lead sponsor
DANU Sports Ltd
Collaborator