Smart Wearable Device (gaitQ) That Helps People With Long-term Conditions Affecting Movement: Walk Better

University of Exeter2 个研究点分布在 1 个国家目标入组 98 人开始时间: 2023年9月15日最近更新: 2026年5月27日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Exeter
入组人数: 98
试验地点: 2
主要终点: Step length

研究概览研究设计入排标准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 study will be underpinned by the new MRC guidelines for developing a complex intervention with a participatory design methodology that uses evidence-based research and behaviour change models alongside COSMIN methodology for validating a measure. Research question: To what extent does gaitQ's smart cueing system improve people with long-term conditions including people with Parkinson's (PwP's) gait? Is it effective in the everyday environment? What factors are associated with good mobility? What is the impact of cueing on healthy people? Aims and objectives: To finalise the product development and evaluation comprising (1) algorithm refinement and (2) monitoring system development. To evaluate the reliability, concurrent validity, and potential for efficacy, as determined by responsiveness in response to the gaitQ product using gait data collected in laboratory environments. To prepare for market entry and NHS adoption: early economic modelling, pricing, marketing strategies, and early adopter partnerships.

Design: Participatory design with testing for validity, reliability and responsiveness Participants: This will involve healthy people and people with long-term conditions affecting their movement, including people with Parkinson's [PwP]. Additional patient groups will be investigated, including stroke, and people with hip/knee injuries.

Methods The Researchers will collect movement data using the gaitQ system, which monitors and cues, to both collect data and cue in the lab environment and investigate the reliability of the measure, concurrent validity of the metric to gold standard gait capture, the responsiveness of measures to the cueing system and usability for participants and clinical teams. To determine reliability, 60 participants will be invited to repeat testing on a second visit. Researchers will describe participants' conditions using standard questionnaires and their mobility and functioning.

详细描述

Detailed Description:

Mobility issues affect 1/3 of the adult population requiring rehabilitation. Current shortages in skilled rehabilitation professionals require novel approaches to address this unmet rehabilitation need. Rehabilitation typically sets out to monitor and support people to live life as they wish using appropriate therapies. Here the investigators propose to develop and test a gait device for people with mobility issues. The investigators will first focus on people with Parkinsons' (PwP) and then on people with other conditions affecting their movement, including stroke and arthritis. There are several practical challenges to bring cueing to the daily lives of PwP: PwP have difficulty multi-tasking. Basic rhythmic cueing methods do not adapt to changes in gait quality or the activities undertaken.

PwP habituates to cues that are constantly in action. These challenges limit the effectiveness and adoption of current cueing products by PwP. gaitQ is developing a smart cueing device that: 1) directly addresses these challenges enabling an effective, practical solution for everyday use; 2) aims to improve quality of life, and mental well-being and reduce fall risks; 3) supports more effective and accurate disease management; and 4) does this in a way that preserves PwP's discretion and privacy.

GaitQ:

The gaitQ system comprises two wearable devices worn on the back of the user's legs. The devices provide vibrational cues with specific patterns tailored to the user's walking characteristics to help them overcome FOG and FSG, and improve their normal gait quality, such as stride length and step symmetry. As Parkinson's gait symptoms contribute to a two-fold risk of falling in PwP, by enabling a more fluid and stable gait while reducing the occurrence of FOG and FSG, the gaitQ system sets out to help reduce the risk of falling. By the time of the trial, gaitQ device will be certified with UKCA certificate.

研究设计

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

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Eligibility Criteria This research will investigate the impact of the gaitQ product on a sufficiently large cohort of PwP, healthy controls and other potential conditions such as stroke and hip and knee replacements.
•Inclusion criteria
•Participants with long-term conditions affecting movement
•Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition-specific scales [stroke, multiple sclerosis, arthritis or osteoporosis]
•Able to self-report history of daily gait freezing and/or festination for people with PD or gait affected by condition
•Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carry out this level of exercise
•Adult (+18 years old)
•Normal or corrected-to-normal vision (Snellen Visual Acuity > 12/18) or safe to mobilise with support
•Montreal Cognitive assessment score >21 or ability to follow 2-stage commands
•Healthy participants
•With no long-term conditions affecting movement
•Able to walk unsupported or using an aid for at least 3 minutes and satisfactory completion of the Canadian PARQ and if over 69 used to carrying out this level of exercise
•Adult (+18 years old)
•Normal or corrected-to-normal vision (Snellen Visual Acuity > 12/18) or safe to mobilise with support
•Montreal Cognitive assessment score >21 or ability to follow 2 stage commands 7.1.2

排除标准

•Participants with long-term conditions affecting movement
•Any physical or mental condition affecting the ability to safely participate in this level of activity and capacity to understand testing as demonstrated by ability to safely follow commands and pass the PARQ by the research team.
•Cognitive impairment affecting the ability to safely participate and follow instructions
•Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)
•Any skin conditions or broken skin in the calf and behind the knee area
•Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system
•Healthy participants
•Any physical or mental condition affecting the ability to safely participate in this level of activity and capacity to understand testing as demonstrated by the ability to safely follow commands and pass the PARQ by the research team.
•Cognitive impairment affecting the ability to safely participate and follow instructions
•Any injury or disorder that may affect balance (other than Parkinson's or referring primary condition)
•Any skin conditions or broken skin in the calf and behind the knee area
•Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system