Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease
Recruiting · NCT07281794 · Observational (researchers observe without assigning treatment) · Lead sponsor: Northumbria University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.)
Where it is running
2 locations listed.
- Northumbria University - Newcastle upon Tyne, United Kingdom
- Northumbria University - Newcastle upon Tyne, Tyne and Wear, United Kingdom