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临床试验/NCT06534177
NCT06534177尚未招募不适用

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

University of Exeter0 个研究点目标入组 80 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Home/community validation

研究概览

简要总结

People with Parkinson's have infrequent clinical consultation (once every 12-18 months) and limited rehabilitation.

Assessment play an important role in these consultations to help clinicians understand patients' health status and disease progression necessary to adjust treatment plans. The current way of measuring is the UPDRS which needs a clinician to do this and takes 30 minutes. There is a strong need for more frequent and accurate Parkinson's assessments in the clinic and at home to detect changes early and then give appropriate support and drug and physiotherapy quickly. There is a need to develop good home digital physiotherapy tools to increase the amount of therapy. Here the investigators are testing new digital technologies to do these assessments in the home and clinic and a new digital physiotherapy device in the home. The investigators aim to conduct a clinical study with 50 people with Parkinson's (50 from UK) with the UPDRS, (a rating scale that is commonly used in clinical settings to evaluate the progression of Parkinson's disease) and 30 healthy adults. The investigators will develop and investigate if two new digital devices, one the MachineMD that measures eye movement and one the gaitQ that measures gait can be used instead of the MDS-UPDRS (motor) using digital gait and ophthalmic features in the clinic setting. The investigators will investigate the effect of a physiotherapy gait intervention gaitQ Tempo in the home context for two weeks and of doing the gait measure at home. The investigators will determine the potential of the gaitQ intervention to improve key gait metrics in order to collect clinical evidence and of using the gaitQ as a cuing system over a 2-week period on gait and other movement measures in the home and community

详细描述

Diagnosis: The current state of the art in diagnosing PD primarily revolves around clinical assessments based on symptomatology and neurological examination. The most widely used criteria for diagnosis are Movement Disorder Society (MDS) criteria and instrument (i.e. The MDSUPDRS). These criteria are highly dependent on the expertise of the diagnosing physician, and thus, are subject to variability. Furthermore, these clinical assessments are unable to accurately track disease progression over time, making it difficult to provide personalized care.

Assessment: plays an important role in these consultations to help clinicians understand patients' health status and disease progression necessary to adjust treatment plans. Current clinical methods rely on the UPDRS a standard clinical outcome measure that requires clinical expertise and training and is thus measured at clinical appointments.

Further information may be gained from patients' 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, patients' 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 patient has cognitive impairment). Walking tests, although quick to perform, show high variability due to natural fluctuations of the Parkinson's symptoms throughout the day, on/off medication status as well as the 'performing' effects when doing activities in a clinical setting. Consequently, Parkinson's care regimes are often provided on a trial-and-error basis, with resulting general delay in offering care, with early signs of disease progression often missed until conditions become more severe, and interventions such as physiotherapy are often provided too late. Hence, there is a strong need for more frequent and accurate Parkinson's assessments in a real-world environment to enable more targeted care and preventative measures and interventions via early detection of disease inflection points. Here the investigators propose to evaluate three digital approaches to see if they provide further information to support clinical decision making using gait and ophthalmic features. The current state-of-the-art in neurological diagnostics includes a range of traditional clinical examination techniques, such as manual neuro-ocular and neuro-motor function assessments, as well as more technologically advanced tools, such as imaging technologies (e.g., MRI) and electrophysiological tests (e.g., ECG). While these methods have undoubtedly contributed to significant advances in the detection and management of neurological disorders, they also present several limitations that digital approaches overcome. Traditional examinations of neurological function, such as manual assessments [UPDRS], are heavily reliant on the expertise and subjective judgment of specialized neurologists. This leads to known inconsistencies in interpreting and scoring patient performance over time, particularly in the case of neurodegenerative diseases like Parkinson's disease (PD), where patients typically consult different resident neurologists over several years.

Additionally, manual examinations lack precise measurement instruments, resulting in a low precision of observed measurements (typically ~ 2 cm) and the inability to detect early-stage, subclinical signs. PD is a complex and progressive neurodegenerative disorder with significant variability in clinical manifestations and disease progression.

Its diagnosis and monitoring remain a challenge, primarily relying on clinical examinations that are subjective and often do not capture the full extent of symptom fluctuations.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • 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 long-term conditions affecting movement
  • 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 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

结局指标

主要结局

Home/community validation

时间窗: 2 weeks

To describe the feasibility of daily measuring in the home of gaitQ tempo to determine usability and acceptability from metrics and completion of measures

Reliability testing of GaitQ wearable device

时间窗: 2 weeks

To determine the extent of the reliability of the digital measures in the context of test-retest reliability taken over 2 weeks in a lab/clinic setting

Lab validation of MachineMD opthalamic device vs UPDRS

时间窗: 2 weeks

To determine criterion validity to the UPDRS by describing the extent of the relationship of the digital measures taken during mobility testing and neuro-Opthalmic testing in the lab/clinic to the UPDRS

Reliability data collection for determining minimally important differnce

时间窗: 2 weeks

To determine initial values of the gaitQ of minimally important difference in relation to the TUG scores taken during the same period in the home sertting

Determine intervention potential

时间窗: 2 weeks

To determine the potential for effect of the gaitQ intervention to improve key gait metrics taken during the standard tasks of TUG, 5-minute walk and 15 m walk, in order to collect clinical evidence as determined by responsiveness, of using the gaitQ as a cuing system over a 2-week period on gait and other movement measures in the home and community

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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