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临床试验/NCT04223245
NCT04223245已完成不适用

A Comparison Of Home Exercises With Multimodal Real-time Sensory Feedback To The Same Exercise Program With No Enhanced Feedback on Walking Automaticity in People With Parkinson Disease.

Regis University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
2
主要终点
Changes in temporalspatial components of Gait

研究概览

简要总结

People with Parkinson Disease (PWPD) have significant problems with velocity, safety and dual tasking during walking that may be secondary to poor automaticity. Sensory functions, especially visual dependence and proprioceptive integration are critical for efficient walking and are often impaired. This home program compares the use of multimodal sensory feedback during stepping and balance exercises in PWPD to a group without the sensory feedback performing the same basic exercises.

详细描述

Parkinson disease impairs motor and sensory functions. Automaticity of gait is lost increasing the use of higher center control of walking, leading to cognitive fatigue, slower movement and motor errors. People with Parkinson disease (PWPD) improve motor performance when external sensory cues, which bypass the faulty basal ganglia, are used during interventions. Enhancing proprioceptive, visual and vestibular cues that are critical for walking has the potential to improve gait and decrease cognitive fatigue by restoring automaticity.

This is a single-blinded randomized controlled study with repeated measures to evaluate the effects of a home exercise program with or without the addition of multi-modal sensory feedback (MMSF) in real-time on automaticity of gait and balance. PWPDs are randomly assigned to one of 2 home exercise groups. There are two 6 week exercise sessions with a 6 week of no exercises inter-spaced between them. The exercises promote rapid and large movement in stepping activities, balance using self-perturbation through single, leg swings and standing on a compliant surface for sensory re-weighting. People in the experimental group perform the program with real-time with MMSF. Participants are to progress exercises in speed and distance as well as performing with eyes closed to improve proprioceptive processing and automaticity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

blinded to subject group assignment

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medical diagnosis of Parkinson Disease
  • A score of 26 or higher on the Mini-Mental Status Exam
  • Able to stand from sitting and take 5 steps without assistance
  • People who have been on the same dosages of medication for PD for 3 weeks or longer

排除标准

  • Participating in an exercise program for less than 3 months
  • Plans to change a current exercise program during the study
  • Changes in medications that affect PD or its sequelea

结局指标

主要结局

Changes in temporalspatial components of Gait

时间窗: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise

temporal and spacial components of gait measured with Gaitrite Mat

changes in balance

时间窗: baseline before exercise training, 6 weeks, 12 weeks and 18 weeks after initiation of exercise

single leg stance time, time standing on foam eyes closed, Mini-BESTest

Change in cognitive attention needed for gait

时间窗: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise

3 meter walk test performed at comfortable gait speed once and repeated while subtracting 3s from 100 to assess cognitive attention needed for walking tasks (automaticity)

Change in perceived difficulty during gait and ADLs,

时间窗: Baseline, 6 weeks, 12 weeks and 18 weeks after initiation of exercise

Parkinson Disease Questionnaire (PDQ-39)

次要结局

未报告次要终点

研究者

发起方
Regis University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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