Healthy (Controls), Parkinson Disease (PD)
Conditions
Keywords
DANU, Clinical Validation, Wearable Electronic Devices
Brief summary
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.
Detailed description
Methods: Institutional ethics have been obtained (Project ID: 8543). Utilising an observational design, participants will be asked to attend one visit 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 to act as descriptive measures. Following this, the investigators will conduct a concurrent data collection throughout a battery of motor tasks. The DANU system will be used alongside APDM Mobility Lab throughout the full duration of data collection. Mobility assessments include a 2-Minute Walk Test, 3 walkway trials, a Timed Up and Go and a series of 2-Minute Balance tasks.
Interventions
None listed
Sponsors
Northumbria University
DANU Sports Ltd
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Parkinson's Group Inclusion Criteria:- Clinical diagnosis of Parkinson's by a movement disorder specialist according to UK brain bank criteria. * 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 Parkinson's Group
Exclusion criteria
* 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.) Healthy Control Inclusion Criteria: * Ability to attend Northumbria University, Newcastle Upon Tyne for study visits. * Aged 50 years old or over. * Able to walk and stand unassisted for a minimum of 2-minutes. Healthy Control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stride Length | Outcomes will be obtained in one visit (Day 1). | (m, mean ± standard deviation) |
| Step Time | Outcomes will be obtained in one visit (Day 1). | (s, mean ± standard deviation) |
| Stride Time | Outcomes will be obtained in one visit (Day 1). | (s, mean ± standard deviation) |
| Cadence | Outcomes will be obtained in one visit (Day 1). | (steps per minute, mean ± standard deviation) |
| Ground Contact Time | Outcomes will be obtained in one visit (Day 1). | (s, mean ± standard deviation) |
| Swing Time | Outcomes will be obtained in one visit (Day 1). | (s, mean ± standard deviation) |
| Stride Velocity | Outcomes will be obtained in one visit (Day 1). | (m/s, mean ± standard deviation) |
| Gait Velocity | Outcomes will be obtained in one visit (Day 1). | (m/s, mean ± standard deviation) |
| Area of Ellipse | Outcomes will be obtained in one visit (Day 1). | (mm², mean ± standard deviation) |
| Length of Ellipse | Outcomes will be obtained in one visit (Day 1). | (mm, mean ± standard deviation) |
| Width of Ellipse | Outcomes will be obtained in one visit (Day 1). | (mm, mean ± standard deviation) |
| Total Displacement | Outcomes will be obtained in one visit (Day 1). | (mm, mean ± standard deviation) |
| Medio-Lateral Range | Outcomes will be obtained in one visit (Day 1). | (mm, mean ± standard deviation) |
| Anterior-Posterior Range | Outcomes will be obtained in one visit (Day 1). | (mm, mean ± standard deviation) |
Countries
United Kingdom
Contacts
CONTACTGabriella R Gatti, BSc
CONTACTRodrigo Vitorio, PhD
PRINCIPAL_INVESTIGATORRodrigo Vitorio, PhD
Northumbria University
Outcome results
None listed