Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinson Disease (PD), Healthy (Controls). Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Stride Length [Time frame: Outcomes will be obtained in one visit (Day 1).]
- Step Time [Time frame: Outcomes will be obtained in one visit (Day 1).]
- Stride Time [Time frame: Outcomes will be obtained in one visit (Day 1).]
- Cadence [Time frame: Outcomes will be obtained in one visit (Day 1).]
- Ground Contact Time [Time frame: Outcomes will be obtained in one visit (Day 1).]
- Swing Time [Time frame: Outcomes will be obtained in one visit (Day 1).]
- Stride Velocity [Time frame: Outcomes will be obtained in one visit (Day 1).]
- Gait Velocity [Time frame: Outcomes will be obtained in one visit (Day 1).]
- Area of Ellipse [Time frame: Outcomes will be obtained in one visit (Day 1).]
- Length of Ellipse [Time frame: Outcomes will be obtained in one visit (Day 1).]
Eligibility 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 Exclusion Criteria:
- History of neurological disorders (e.g. Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)
- Significant issues that may affect walking (e.g., musculoskeletal issues, back pain, recent surgery etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United Kingdom · 2 centers
- Northumbria University — Newcastle upon Tyne
- Northumbria University — Newcastle upon Tyne
Identifiers
NCT: NCT07281794 · 8543b