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临床试验/NCT05794542
NCT05794542已完成不适用

Cue X as a Treatment for People With Parkinson's Disease

University of Leeds1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
EQ-5D-5L (This is the registered name of the outcome measure)

研究概览

简要总结

Parkinson's disease is a progressive neurological condition which affects more than 145,000 people in the United Kingdom (UK) today. The main symptoms are tremor (uncontrolled shaking), slowness of movement and difficulty starting movements (termed 'freezing'). Daily exercise is recommended to help with these symptoms.

Rehabilitation can help to maintain a person's balance, ability to walk and help to prevent falls. This can allow people living with Parkinson's to maintain their independence for longer. Rehabilitation is usually carried out at face-to-face appointments in outpatient departments in hospitals.

STROLLL (www.strolll.co) is a company that have created a programme of activities called Cue X, to be used on augmented reality glasses. Augmented reality glasses merge computer generated images and sounds with the real world. Cue X has been created specifically to help people with Parkinson's.

We are aiming to recruit 50 participants through referrals from specialist doctors, nurses and physiotherapists in Leeds Teaching Hospitals National Health Service (NHS) Trust. We will ask these health care professionals to give potential participants an information sheet outlining the project. A more detailed participant information sheet will be sent by post or email to those interested.

There will be an initial hospital appointment where written consent will be asked for and an initial assessment completed. Participants will do a personalised, daily rehabilitation programme using Cue X on augmented reality glasses for 6 weeks at home (monitored remotely by a physiotherapist). A final assessment and review will be done in hospital.

The purpose of this project is to see if people with Parkinson's can use the glasses and do exercises in their own homes. Benefits could include fewer trips to the hospital for appointments and a more engaging way of participating in rehabilitation.

If successful, this could lead further research into this technology as a new way of delivering rehabilitation.

详细描述

Parkinson's disease is a condition that affects the brain. It is the world's fastest growing neurological condition which affects more than 145,000 people in the United Kingdom (UK) today. No one knows exactly why the condition develops and there is currently no cure for Parkinson's.

The symptoms associated with Parkinson's are usually mild at first, but can become worse over time. The main symptoms are tremor (uncontrolled shaking), slowness of movement and difficulty starting movements. People with Parkinson's often have problems with walking and balance because of these. This can make normal daily activities more difficult.

It is generally recommended that adults are physically active every day to reduce the effects of sedentary behaviour. UK Department of Health and Social Care guidelines for the adult population recommend 150 minutes of moderate intensity physical activity (equivalent to 30 minutes per day, 5 days a week) or 75 minutes of vigorous intensity physical activity a week (gov.uk, 2019). This is no different for people living with Parkinson's. Indeed, people living with Parkinson's are encouraged to engage in a daily exercise programme to maintain their mobility, independence, and quality of life. However, it can be difficult to do exercises because of the disabling symptoms affecting movement. In addition, as gait and balance ability deteriorate, and the fear of falls increases, maintaining an exercise programme becomes more difficult, leading to being less able to do everyday activities and declining quality of life.

Rehabilitation can help people living with Parkinson's to maintain their mobility and independence, as well as assisting in preventing falls. People usually attend outpatient appointments with a specialist rehabilitation team for assessment and are commenced on a treatment programme of advice, exercises and activities. People are reviewed regularly at face-to-face appointments, with treatment plans adjusted as needed.

One particular problem that many people report with their mobility is 'freezing' when walking (termed 'freezing of gait' or FoG). This is when a person stops and is unable to take their next step. Previous research has shown that there are ways to help people when they freeze using visual or auditory cues to provide 'prompts' to take the next step. For example, putting taped lines on the floor to step over, a light on a walking stick or listening to the beat of a metronome. Most of the existing technology relies on someone else being present, carrying a walking aid or the lines being in fixed places on the floor.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Age >= 18 years Confirmed Parkinson's diagnosis Under the care of a consultant or Parkinson's specialist nurse in Leeds. Able to walk indoors with or without a walking aid

排除标准

  • Age < 18 years Skin condition on head or face that prevents wearing the headset Cognitive impairment causing inability to consent Unable to walk at any time Severe visual impairment resulting in inability to see the augmented reality information Epilepsy Mental health condition causing hallucinations

结局指标

主要结局

EQ-5D-5L (This is the registered name of the outcome measure)

时间窗: At 6 weeks: on completion of the intervention

5-level EuroQoL-5 dimension: health related quality of life assessment

次要结局

  • Lindop Parkinson's Assessment Scale(At 6 weeks: on completion of the intervention)
  • The Parkinson's Disease Questionnaire (PDQ-39)(At 6 weeks: on completion of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Rory O'Connor

Charterhouse Professor of Rehabilitation Medicine

University of Leeds

研究点 (1)

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