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Speed of Processing Training in Patients With Parkinson's Disease and Healthy Older Adults

2018年3月22日 更新者:Amy Amara, MD、University of Alabama at Birmingham

The Effect of Speed of Processing Training on Pedestrian Behavior in Patients With Parkinson's Disease and Healthy Older Adults

The purpose of this prospective, within-subject randomized cross-over design study is to determine if a computer training program (Speed of Processing Training - SOPT) improves safe pedestrian behavior in patients with Parkinson's disease and in healthy older adults in a virtual reality pedestrian environment. Pedestrian injury poses significant risk to healthy older adults and patients with Parkinson's disease. Several age-related changes, including slowing of visual processing speed, increase risky pedestrian behavior. This study will determine if SOPT improves pedestrian behavior in patients with Parkinson's disease and healthy older adults and evaluate the persistence of the SOPT training effects.

研究概览

详细说明

Pedestrian injury poses significant risk to healthy older adults and patients with Parkinson's disease. Several age-related changes, including slowing of visual processing speed, increase risky pedestrian behavior. Persons with Parkinson's disease (PD) are at even higher risk of pedestrian injury due to motor and non-motor symptoms. Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms including slowness, tremor, stiffness, and balance problems. Visual processing speed abnormalities, anxiety, and cognitive problems are common non-motor symptoms.

The Useful Field of View (UFOV®) test is a measure of visual processing speed. The UFOV® test is performed on a touch-screen computer that displays objects in the central and peripheral visual fields for brief durations. Successful performance on the test requires integration of visual sensory information and higher-order cognitive processing. Our own research has shown that the UFOV® test performance correlates with pedestrian behavior in PD patients.

Speed of Processing Training (SOPT) is a computer-based training that uses visual exercises to improve cognitive processing. The training involves identifying and localizing visual information quickly in increasingly demanding visual displays. SOPT has been demonstrated to improve performance on the UFOV test in healthy older adults and PD patients. It is hypothesized that SOPT training will improve pedestrian safety in healthy older adults and PD patients.

In the proposed study, we will use a within-subject, randomized, controlled, cross-over design to evaluate if a computer training program (Speed of Processing Training - SOPT) improves safe pedestrian behavior in patients with Parkinson's disease and in healthy older adults in a virtual reality pedestrian environment and if the effects of training persist long-term.

研究类型

介入性

注册 (实际的)

88

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alabama
      • Birmingham、Alabama、美国、35233
        • University of Alabama at Birmingham

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria Parkinson's disease Subjects:

  • Subjects with a clinical diagnosis of idiopathic Parkinson's disease based on the presence of bradykinesia and one or both of the following: rest tremor and/or rigidity
  • On stable medications for at least 4 weeks prior to entering the study and expected to not need any medication changes for the duration of the study
  • Age ≥50 at the time of entry into the study
  • Age of onset of Parkinson's disease 45 - 85 years old
  • Asymmetric onset of PD
  • Progressive motor symptoms of PD
  • Hoehn and Yahr stages 1-4
  • Ability to walk up and down a single stair step
  • Access to a computer with internet

Exclusion Criteria Parkinson's disease Subjects:

  • Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
  • Neuroleptic treatment at time of onset of Parkinsonism
  • Active treatment with a neuroleptic at time of study entry
  • History of multiple strokes with stepwise progression of Parkinsonism
  • History of multiple head injuries
  • Inability to walk without assistance, including a cane, wheelchair, or walker
  • Cognitive dysfunction that would prevent subject's ability to perform virtual reality simulation, speed of processing training, or complete questionnaire
  • Blindness
  • Any medical condition that, based on discretion of the PI, would prevent the subject's ability to participate in the study

Inclusion Criteria Control Subjects:

  • Age ≥50 at the time of entry into the study
  • On stable medications for at least 4 weeks prior to entering the study and expected to not need any medication changes for the duration of the study
  • Ability to walk up and down a single stair step
  • Access to a computer with internet

Exclusion criteria Control Subjects:

  • Parkinson's disease or other neurodegenerative disorder
  • Inability to walk without assistance, including a cane, wheelchair, or walker
  • Cognitive dysfunction that would prevent subject's ability to perform virtual reality simulation, speed of processing training, or complete questionnaires
  • Blindness
  • Any medical condition that, based on the discretion of the PI, would prevent the subject's ability to participate in the study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Control Initial Training Group
Healthy Controls will receive initial SOPT training and will be compared against controls in the delayed training group and the PD subjects in the initial training group
This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.
其他名称:
  • InSight (registered trademark of Posit Science, Inc.)
有源比较器:Control Delayed Training Group
Healthy Controls will receive delayed SOPT training and will be compared against controls in the initial training group and the PD subjects in the delayed training group
This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.
其他名称:
  • InSight (registered trademark of Posit Science, Inc.)
其他:PD Initial Training Group
PD subjects will received initial SOPT training and will be compared against PD subjects in the delayed training group and the control subjects in the initial training group
This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.
其他名称:
  • InSight (registered trademark of Posit Science, Inc.)
其他:PD Delayed Training Group
PD subjects will receive delayed SOPT training and will be compared against PD subjects in the initial training group and the control subjects in the delayed training group
This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.
其他名称:
  • InSight (registered trademark of Posit Science, Inc.)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Time to contact
大体时间:3 months
Difference in time to contact between baseline and immediate post-training assessments in PD and healthy controls
3 months

次要结果测量

结果测量
措施说明
大体时间
Useful Field of View (UFOV)
大体时间:3 months
Difference in UFOV total score between baseline and immediate post-training assessments in PD and healthy controls
3 months
Executive function (MoCA, Trails, Stroop)
大体时间:3 months
Difference in MoCA, Trails, and Stroop between baseline and immediate post-training assessments in PD and healthy controls
3 months
Vigilance
大体时间:3 months
Differences in vigilance as measured by psychomotor vigilance task between baseline and immediate post-training assessments in PD and healthy controls
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Amy Amara, MD, PhD、University of Alabama at Birmingham

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年2月1日

初级完成 (实际的)

2018年2月1日

研究完成 (实际的)

2018年2月1日

研究注册日期

首次提交

2016年10月7日

首先提交符合 QC 标准的

2016年10月7日

首次发布 (估计)

2016年10月11日

研究记录更新

最后更新发布 (实际的)

2018年3月26日

上次提交的符合 QC 标准的更新

2018年3月22日

最后验证

2018年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • X150203003
  • 5P30AG022838 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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