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

Northumbria University2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2025年8月8日最近更新: 2026年2月12日

试验速览

阶段: 不适用
状态: 招募中
发起方: Northumbria University
入组人数: 60
试验地点: 2
主要终点: Stride Length

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Cross Sectional

入排标准

年龄范围: 50 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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.)

研究组 & 干预措施

Healthy Control (HC)

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.

Parkinson's Disease (PD)

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.