跳至主要内容
临床试验/NCT04863560
NCT04863560Unknown不适用

Brain Activity Response to Cues During Gait in Parkinson's

Northumbria University3 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
3
主要终点
Change in cortical oxygenated hemoglobin (HbO2) signal during walking

研究概览

简要总结

Lay Summary:

Walking problems, such as slow and short steps, are very common in Parkinson's disease and lead to increased falls risk, as well as reduced mobility and quality of life. Walking issues are difficult to treat as medication interventions do not restore walking ability in people with Parkinson's, therefore physiotherapy approaches are used to help improve walking. Various physiotherapy strategies have been used, such as internal (thinking about bigger steps) or external prompts. External prompts include auditory (a metronome beat to step in time to), visual (lines to step over on the floor) and tactile (metronome-like vibration to step with) prompts that are very commonly used to improve walking in Parkinson's. However, the reason why walking improves in people with Parkinson's with these physiotherapy strategies is unknown, which has led to not all patients benefiting and only short-term walking improvements being seen.

The main issues are that it is unclear if these various internal or external prompt strategies are effective with the progression of Parkinson's disease, and it is unknown which type of strategy is most effective at different disease stages or with more severe walking impairment, such as freezing (the inability to progress walking for short periods despite wanting to do so). Being able to use specific brain regions to pay attention to different internal or external prompts has been suggested to be the reason why people with Parkinson's can overcome their walking problems, but this has not been tested. Therefore, this study will use state-of-the-art digital technology to measure walking and brain activity changes with different internal and external prompts. The investigators think that the walking improvement with different prompt strategies relies on the ability to activate specific brain regions, and that brain region activity in response to internal or external prompts will change at different stages of Parkinson's disease.

Ultimately, understanding the reasons why people benefit from these physiotherapy strategies and who benefits most from specific strategies will enable clinicians to provide more timely and efficient treatment for people with Parkinson's, and to develop more effective strategies to further improve walking.

研究设计

研究类型
Observational
观察模型
Cohort
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
否

入选标准

  • •Clinical diagnosis of Parkinson's by a movement disorder specialist according to United Kingdom (UK) brain bank criteria
  • •Hoehn & Yahr (H&Y) stage I-III
  • •Aged >50 years
  • •Able to walk and stand unaided
  • •Adequate hearing (as evaluated by the whisper test; stand 2m behind subject and whisper a 2 syllable word, subject repeats word) and vision capabilities (as measured using a Snellen chart - 6/18-6/12).
  • •Stable medication for the past 1 month and anticipated over a period of 6 months

排除标准

  • •Psychiatric co-morbidity (e.g., major depressive disorder as determined by Geriatric Depression Scale - short form (GDS-15); <10 [26])
  • •Clinical diagnosis of dementia or other severe cognitive impairment (Montreal cognitive assessment <21 [27])
  • •History of stroke, traumatic brain injury or other neurological disorders (other than PD, for the PD group)
  • •Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
  • •Unstable medical condition including cardio-vascular instability in the past 6 months
  • •Unable to comply with the testing protocol or currently participating in another interfering research project
  • •Interfering therapy

结局指标

主要结局

Change in cortical oxygenated hemoglobin (HbO2) signal during walking

时间窗: immediately after intervention

Change in cortical oxygenated hemoglobin (HbO2) measured while walking with cueing, which will be quantified with a wireless functional near infrared spectroscopy (fNIRS) system

Change in cortical power spectral densities during walking

时间窗: immediately after intervention

Change in cortical power spectral densities of EEG signals from cortex with cueing, which will be quantified with a mobile electroencephalography (EEG) system

次要结局

  • Change in Stride Length (m)(immediately after intervention)
  • Change in Gait Speed (m/s)(immediately after intervention)
  • Change in Stride Time (s)(immediately after intervention)
  • Change in Gait Variability (SD)(immediately after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验