Objective Mobility Assessment Using Wearable Technology for Clinical Application in Parkinson's Disease: From Validation to Fall Prediction

Northumbria University

Status: Invitation-only

Conditions: Parkinson Disease(PD)

Study type: Observational

Funder types: Other

Identifiers

NCT07281755

8543a

Details and patient eligibility

About

The main objective of this observational trial is to explore the validity and reliability of DANU smart socks when used for mobility assessments in people with Parkinson's. Using a series of laboratory gold standard equipment, this project aims to compare the metrics observed by DANU to the reference standards. No intervention is included. Specifically, this study will explore metrics relating to walking (gait) and balance of a Parkinson's cohort through a series of motor tasks. Moreover, this study seeks to investigate the clinical validity of DANU outcome metrics exploring relationships with clinical scales, fall history and prospective falls.

Full description

Background:

Mobility impairments are common in Parkinson's disease (PD) and increase the risk of falling. Data derived from wearable inertial measurement units can provide useful information regarding gait in different situations and environments, which may help to identify those at risk of falling. However, rigorous testing is required to evaluate whether new devices are fit for purpose. DANU Smart Socks are a multi-modal system for movement analysis, containing 15 silicone based capacitive pressure sensors and an IMU pod, with tri-axal accelerometers, gyroscope and magnetometers, currently at use within a sporting context. Potential has been highlighted for clinical use in people with Parkinson's (PwP). This study aims to evaluate the validity, reliability and usability of the DANU Sport System in PwP for balance and gait assessment. The V3+ framework for determining fit-for-purpose biometric monitoring devices will be employed, evaluating verification, usability, analytical and clinical validation.

Methods:

Institutional ethics have been obtained (Project ID: 8543). Utilising a a repeated measures observational design, participants will be asked to attend two visits 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. Following this, concurrent data collection will occur throughout a battery of motor tasks to observe gait/balance metrics. Laboratory references employed include Axivity AX6, Vicon 3D Motion Capture, APDM Mobility Lab, GAITRite and AMTI Force Plates. Mobility assessments include a 2-Minute Walk Test, 3 walkway trials, a Timed Up and Go and a series of 2-Minute Balance tasks.

Visit 2: Participants attend a second visit to repeat the mobility assessment previously detailed utilizing DANU Smart Socks and APDM Mobility Lab systems to explore test-retest reliability.

Wearable device (DANU) validity and reliability will be examined using intra-class correlation coefficients and Bland-Altman plots to compare to laboratory reference standards. Moreover time series plots will be employed to evaluate the raw data agreement.

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Parkinson's by a movement disorder specialist according to UK brain bank criteria.
• Hoehn & Yahr stages I-III
• Able to attend Northumbria University, Newcastle Upon Tyne for study visits
• Able to walk and stand unassisted for a minimum of 2-minutes

Exclusion criteria

• History of neurological disorders other than PD (e.g., Huntington's disease, stroke, traumatic brain injury, multiple sclerosis, Alzheimer's disease etc.)
• Montreal Cognitive Assessment (MoCA) score < 21
• Injury to the lower extremities within the past 6-weeks.

Trial design

60 participants in 1 patient group

Parkinson's Disease (PD)

Description:

People with a clinical diagnosis of Parkinson's Disease will be recruited to participate within the study. All participants must fit within the described eligibility criteria. Within the verification and analytical validation phase 30 people with Parkinson's will be recruited and within clinical validation 60 individuals will be recruited.