Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorNorthumbria University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Parkinson's Disease (PD)
Group B: Healthy Control (HC)
Trial outcomes
Primary outcomes
1
Stride Length
(m, mean ± standard deviation)
Time frame
Outcomes will be obtained in one visit (Day 1).2
Step Time
(s, mean ± standard deviation)
Time frame
Outcomes will be obtained in one visit (Day 1).3
Stride Time
(s, mean ± standard deviation)
Time frame
Outcomes will be obtained in one visit (Day 1).4
Cadence
(steps per minute, mean ± standard deviation)
Time frame
Outcomes will be obtained in one visit (Day 1).Other outcomes
1
Double Support Time
(s, mean ± standard deviation)
Time frame
Outcomes will be obtained in one visit (Day 1).2
Single Support Time
(s, mean ± standard deviation
Time frame
Outcomes will be obtained in one visit (Day 1).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northumbria University
Lead sponsor
DANU Sports Ltd
Collaborator
Source ClinicalTrials.gov