Gait Disorders in Parkinson's Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 主要终点
- To examine the relative phase variability or coherence between oscillating axial and appendicular components of gait in PD + FOG, compared to PD-FOG and healthy controls.
研究概览
简要总结
Background:
Parkinson s disease (PD) is a neurologic disorder that causes slowness, tremor, rigidity, and imbalance. Gait impairment is also common. There are 2 substudies: (1) Physiology of Freezing and Gait; (2) Vibratory Cueing. Healthy participants can join only Substudy 1.
Objective:
To study gait disorders in PD. Also, to test the effect of specific interventions for gait in people with PD.
Eligibility:
People ages 18 and older who:
Have PD with bilateral symptoms but can walk without a cane or walker
Are healthy
Design:
Participants will be screened in Protocols 93-N-0202 and 01-N-0206.
Both substudies include a physical exam and medical history.
Substudy 1:
Participants will have one 6-hour visit. They must wear a tank tops and shorts with tennis shoes during the visit. They will perform gait tasks. Markers placed on the skin will record movements. They will have an EEG: They will wear an electrode cap to record brain waves. They will wear special glasses to record eye movements. Participants with PD will hold their morning dose of PD drugs. They can choose to be admitted to the hospital the previous evening. Otherwise someone else or a taxi must bring them to the visit. They will first perform the study tasks off their drugs. Then they will take their drugs and repeat them.
Substudy 2:
Participants will have one 3-hour visit. A small vibratory device will be attached to their ankle. Reflective markers placed on the skin will record movements while they walk:
Without the device
With the device, but the vibrator off
With the device, with the vibrator on
With a magnet attached to the ankle
详细描述
The objective of this protocol is to study the physiology of gait disorders in Parkinson s disease as well as to test the effect of non-invasive interventions on gait function in patients with Parkinson s disease. To this end, this protocol will consist of two sub studies:
-
Sub Study 1: Physiology of Freezing of Gait in Parkinson Disease (abbrev: Physiology of FOG)
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Objective: To explore temporospatial gait parameters and joint kinematic patterns in patients with Parkinson disease and freezing of gait. In addition, tracking of eye movements and EEG patterns will also be studied in patients with Parkinson disease and freezing of gait.
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Study Population: 15 PD patients with freezing of gait, 15 patients without freezing of gait, 15 age and gender matched healthy volunteers
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Design: Prospective Exploratory study
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Outcome Measures: Phase variability and coherence of oscillating axial and appendicular components of gait in patients with PD and freezing of gait, visual gaze fixations and saccades during freezing or freezing-like events and when approaching a variable width doorway, EEG patterns during an episode of freezing of gait or freeze-like event. The study will also aim to look at the difference in the phenomenon of FOG in OFF and ON states.
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Sub Study 2: Effects of Rhythmic Vibratory Cueing to Improve Step Parameters in Parkinson Disease (abbrev. Vibratory Cueing)
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Objective: To study changes in gait variables of patients with PD by providing rhythmic vibratory stimuli at the ankle on one limb at preset parameters.
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Study population: 15 patients diagnosed as having Parkinson s Disease, Hoehn and Yahr stage 2-3.
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Design: Prospective interventional hypothesis testing study. We will evaluate the effects of rhythmic vibratory cueing on gait variables in PD. The effects of vibratory cueing will be tested compared to baseline gait variables and with the use of a magnet (which will be the open label placebo intervention to account to some extent, for the open label design).
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PD patients
pd patients using vibratory cueing device
干预措施: vibratory cueing device (Device)
PD patients 1
PD patients with freezing of gait
干预措施: vibratory cueing device (Device)
Healthy Volunteers
Age and gender matched healthy volunteers.
干预措施: Mobile Gait Trainer (Device)
PD patients no
PD patients without freezing of gait
干预措施: Mobile Gait Trainer (Device)
Healthy
HV using Mobile Gait Trainer
干预措施: Mobile Gait Trainer (Device)
结局指标
主要结局
To examine the relative phase variability or coherence between oscillating axial and appendicular components of gait in PD + FOG, compared to PD-FOG and healthy controls.
时间窗: ongoing
Changes in Stride length
时间窗: ongoing
次要结局
未报告次要终点