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临床试验/NCT06733077
NCT06733077招募中不适用

Development of Digital Diagnostics and Intervention Services for Parkinson's Disease

University of Exeter1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Step length

研究概览

简要总结

In this project, ocular motor, pupil and gait data in people with Parkinson's disease (PD) will be collected in order to develop machine learning models for the diagnosis and monitoring of PD. With this, the investigators aim to advance the state of the art in PD diagnosis and monitoring. By integrating the principles of machine learning with high-quality sensor data, more accurate and earlier diagnosis could potentially be achieved. Ocular motor and pupil data will be collected with the standard clinical examination and with neos, a medical device approved for objective ocular motor and pupil measurement. Gait will be collected using an IMU sensor and GaitQ senti, a consumer device that allows for an objective and continuous remote gait monitoring.

详细描述

Parkinson's disease (PD) is one of the most common neurodegenerative diseases worldwide, affecting 1% of the population older than 65.

Currently, PD diagnosis is based on history, clinical assessments, and neurological examination.

The most widely used criteria for diagnosis are the Movement Disorder Society (MDS) criteria and instrument (i.e. The MDS-UPDRS). Further information may be gained from people's subjective description of their symptoms and/or via some short walking tests, such as 3-meter Timed Up and Go (TUG) performed as a snapshot in the clinic. However, people's symptoms vary through and between days and subjective descriptions rely on their memory and observations at home. These recollections can be unreliable or lack enough detail (particularly when the person has cognitive impairment). Therefore, current PD diagnosis criteria are highly dependent on the person and on the diagnosing physician. This subjectivity may lead to a variability in the diagnosis. Furthermore, these clinical assessments are unable to accurately track disease progression over time, making it difficult to provide personalized care. Additionally, manual examinations lack precise measurement instruments, resulting in a low precision of observed measurements and the inability to detect early-stage, subclinical signs. An objective diagnosis based on quantitative data rather than subjective interpretation of clinical findings is important. Therefore, an early and accurate diagnosis of PD, as well as accurate disease progression monitoring, are still important challenges in PD.

Several oculo-visual abnormalities have been described in PD. Studies report an abnormal ocular motor function in 75-87.5% of people with PD. These dysfunctions may precede or follow motor symptoms and thus, the evaluation of ocular motor function may provide valuable information regarding early disease detection or disease progression. The most commonly reported ocular motor dysfunctions are impairments in saccades, smooth pursuit, and vergence.

Gait impairments are among the most common and disabling symptoms of PD. Gait impairments include freezing of gait (FOG), an inability to initiate or maintain normal walking patterns, often resulting in a stochastic stop/start gait, and festinating gait (FSG), which is a shortening of stride length with elevated step frequency, resulting in fast, shuffling steps. Both FOG and FSG contribute to an increased risk of falls (and fall-related injuries) in people with PD relative to the wider elderly population. Objective, and continuous remote gait monitoring would be highly important in people with PD, to objectively track gait impairments in real-time, and potentially contribute to objectively track disease progression, which may lead to personalized care for individuals with PD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • •Participants with Parkinson's [Phase 1,2,3,4]
  • •Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition specific scale [stroke, multiple sclerosis, arthritis or osteoporosis]
  • •Able to self-report history of daily gait freezing and/or festination for people with PD or gait and/or transfers affected by condition
  • •Able to walk unsupported or using an aid for at least 5 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
  • •Healthy participants [Phase 1,2,3]
  • •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

排除标准

  • •Participants with Parkinson's
  • •Any physical or mental condition affecting 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 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 knee area
  • •Deep brain stimulation or pacemaker implants or other implant that may interfere with the measurement system
  • •Medications likely to affect eye sight or use of virtual reality sytstem
  • •Healthy participants
  • •Any physical or mental condition affecting 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 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 knee area
  • •Deep brain stimulation or pacemaker implants or other implants that may interfere with the measurement system

研究组 & 干预措施

Feasibility of using the MachineMD and gaitQ devices

Experimental

To complete gaitQ and MachineMD digital feasibility assessment and intervention service development

干预措施: gait with cueing wearable device and neuro-ocular performance (Device)

结局指标

主要结局

Step length

时间窗: From lab visit 1 to lab visit 2 (up to 3 weeks).

Step length (measured in meters) during the gait tasks (TUG, 5 sit to stand, 15-m walk, 5-min walk).

Step rate

时间窗: From lab visit 1 to lab visit 2 (up to 3 weeks).

Step rate (measured in steps per minute) will be measured during the gait tasks (TUG, 5 sit to stand, 15-m walk, 5-min walk).

Step length symmetry index

时间窗: From lab visit 1 to lab visit 2 (up to 3 weeks).

Step length symmetry index will be calculated using the following equation: \[((R - L)/0.5 × (R + L)) × 100\], where R: right leg, L: left leg

Walking speed

时间窗: From lab visit 1 to lab visit 2 (up to 3 weeks).

Walking speed (meters per second) will be measured during the gait activities (TUG, 5 sit to stand, 15-m walk, 5-min walk).

Timed Up and Go test

时间窗: From lab visit 1 to lab visit 2 (up to 3 weeks).

The time (in seconds) to complete the Timed Up and Go task will be recorded.

Five times Sit to Stand

时间窗: From lab visit 1 to lab visit 2 (up to 3 weeks).

The time (in seconds) a person needs to stand up from a standard height chair and sit back down five times.

15-m Walk

时间窗: From lab visit 1 to lab visit 2 (up to 3 weeks).

The time (in seconds) needed to cover 15 meters in straight line walking

5-min Walk

时间窗: From lab visit 1 to lab visit 2 (up to 3 weeks).

The distance a participant walks in 5 minutes (measured in meters and can round to the nearest decimal place).

Safety of the gaitQ device

时间窗: From lab visit 1 to the end of the intervention (up to 6 weeks).

Safety of the gaitQ device will be assessed by recording the adverse events (expected and unexpected).

Usability of the gaitQ device

时间窗: From lab visit 1 to the end of the intervention (up to 6 weeks).

Usability of the gaitQ device will be assessed through successful establishment of a system usability scale target \>68 and through the number of therapy support sessions required.

Ocular motor and pupil function - Standard manual test

时间窗: From lab visit 1 to lab visit 2 (up to 3 weeks).

Ocular motor and pupil function scores derived from gaze (left, centre, right), ocular alignment, pupilary function, saccades (horizontal, vertical), smooth pursuit, visual field screening, and convergence.

Ocular motor and pupil function - Neos device

时间窗: From lab visit 1 to lab visit 2 (up to 3 weeks).

Ocular motor and pupil function scores derived from gaze (left, centre, right), ocular alignment, pupilary function, saccades (horizontal, vertical), smooth pursuit, visual field screening, and convergence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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