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临床试验/NCT04674319
NCT04674319已完成不适用

Attending to External Cues and Movement Strategies in Parkinson Disease: Feasibility in Ecological Setting.

Galit Yogev-Seligmann1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Swing time percent- Physiological measurement of gait

研究概览

简要总结

People with Parkinson's disease use compensatory strategies to overcome typical gait disturbances. These strategies rely on attentional mechanisms, however people with Parkinson disease suffer of decline in cognitive function. Therefore, the current study aims at exploring brain engagement and focus of attention process during walking with these compensatory strategies, in people with Parkinson disease. Such exploration would assist in understanding the feasibility of the compensatory strategies in daily lives of people with Parkinson's disease.

详细描述

External cues and cognitive movement strategies are common compensatory modes that people with Parkinson's disease can use to overcome typical gait disturbances. It is suggested that these modes utilize alternative neural pathways, bypassing the impaired basal ganglia motor circuits in the brain. In addition, both compensatory modes, in particular the movement cognitive strategies, are suggested to rely on attentional mechanisms.

Cognitive deficits are common in PwP and include among others, impairment of attention, particularly in tasks requiring internal control of attention. Considering that gait compensatory modes may rely on cognitive function, in particular the cognitive movement strategies, it is not clear whether People with Parkinson's disease can engaged with these strategies for a prolonged time or distance as in many cases required in daily living.

Therefore, the objectives of this study are 1) to test the effect of compensatory modes- external cueing and cognitive movement strategy on gait in prolonged walking. 2) to test whether people with Parkinson's disease can stay engaged and focus their attention to these compensatory modes for prolonged time. 3) to test whether subject's cognitive function is related to the ability to stay engaged with these compensatory modes. Subjects are recruited from a community physical- therapy groups for people with Parkinson's disease. Healthy older adults will be recruited from the community and will serve as a control group. Participants are invited for two separate evaluation sessions that includes: 1. Assessment of background characteristic: demographic details, severity of disease ( assessed by the Unified Parkinson's Disease Rating Scale-UPDRS), Levodopa Equivalent Dose (LED), freezing of gait questionnaire (FOG-Q) and Montreal cognitive assessment (MoCA).

  1. Evaluation of gait while attending to external cues and cognitive movement strategy.

  2. Evaluation of brain engagement during gait 4. Computerized cognitive assessment

研究设计

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

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for people with Parkinson's disease:
  • •Diagnosis of Parkinson's disease
  • •Age of 50-85
  • •Able to walk independently in daily lives.
  • •Inclusion Criteria for the control group:
  • •Age of 50-85
  • •Able to walk independently in daily lives.

排除标准

  • •for people with Parkinson's disease:
  • •Use of assistive hearing device
  • •Suffer of hearing impairment (by self-declaration)
  • •Suffer of dementia (MoCa test score above 21)
  • •Suffer of any orthopedic condition
  • •Pains or other health condition that may affect gait except of PD
  • •Exclusion Criteria for the control group:
  • •Use of assistive hearing device
  • •Suffer of hearing impairment (by self-declaration)
  • •Suffer of dementia (MoCa test score above 21)
  • •Suffer of any orthopedic condition
  • •Pains or other health condition that may affect gait

研究组 & 干预措施

Brain engagement while using compesatory modes for walking

Experimental

Brain engagemnent (recruitment of attention) is measured during four walking conditions

干预措施: external cues and cogntive movement strategies (Behavioral)

结局指标

主要结局

Swing time percent- Physiological measurement of gait

时间窗: Through study completion, an average of 1 year

Swing time percent (the percent of time from the total time of one gait cycle that one leg is in the air is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps.These sensors are measuring swing time percent (unit are given in percents)

Electrical activity (eeg) of the brain-phisyological measure of electircal signals

时间窗: Through study completion, an average of 1 year

During the walking, measure of attention recruitment during walking is applied by a single-channel EEG system (Brain-MARC LTD). The system simplifies EEG analysis to adjust the extraction of relevant attention-related markers from ongoing EEG. EEG is sampled using the MindWave dry electrode system \[25\], with one frontal electrode (∼Fpz) and one reference electrode on the earlobe. The sampled data are transferred through a wireless connection to the experiment computer, where the signal is processed. An algorithm is calaculating

Gait speed- Physiological measurement of gait

时间窗: Through study completion, an average of 1 year

Gait speed is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps. These sensors are measuring gait speed (meters per second).

Step length- Physiological measurement of gait

时间窗: Through study completion, an average of 1 year

Step length is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps. These sensors are measuring step length (cm).

Cadence- Physiological measurement of gait

时间窗: Through study completion, an average of 1 year

Cadence is measured with the Mobility Lab OPAL system (APDM, USA) consisting of three small inertial measurement units (IMU sensors including 3D accelerometers and 3D gyroscopes sampled at 128 Hz, MobilityLab, APDM Inc., Portland, OR). IMUs were attached at the participant's ankles, and lumbar region using elastic Velcro straps.These sensors are measuring cadence (number of steps taken in 1 minute).

次要结局

  • Cognitive function Go-NoGo Response Inhibition(Through study completion, an average of 1 year)
  • Cognitive function-Stroop Interference(Through study completion, an average of 1 year)
  • Cognitive function-Staged Information Processing Speed(Through study completion, an average of 1 year)
  • Cognitive function-Finger Tapping(Through study completion, an average of 1 year)
  • Cognitive function-'Catch' Game(Through study completion, an average of 1 year)
  • Cognitive function-Problem Solving(Through study completion, an average of 1 year)
  • Cognitive function-executive function index score(Through study completion, an average of 1 year)
  • Cognitive function-Attention index score(Through study completion, an average of 1 year)
  • Cognitive function-Information Processing Speed index score(Through study completion, an average of 1 year)
  • Cognitive function-motor skills index score(Through study completion, an average of 1 year)

研究者

发起方
Galit Yogev-Seligmann
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Galit Yogev-Seligmann

Prinicipal Investigator

University of Haifa

研究点 (1)

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