Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease

Northumbria University

Status: Invitation-only

Conditions: Healthy (Controls); Parkinson Disease (PD)

Study type: Observational

Funder types: Other

Identifiers

NCT07281794

8543b

Details and patient eligibility

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.)

Trial design

60 participants in 2 patient groups

Parkinson's Disease (PD)

Description:

Participants with a clinical diagnosis of Parkinson's Disease meeting the described eligibility criteria will be recruited to take part within this study. The aim is to recruit 60 people with Parkinson's.

Healthy Control (HC)

Description:

Aged-matched (over 50 years old) healthy controls who meet the described eligibility criteria will be recruited to participate in this study. The aim is to recruit 60 participants.