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Home-based Motor Imagery for Gait Stability in Older Adults. A Cross-over Feasibility Study. (MIGS-F) (MIGS-F)

2019年8月5日 更新者:Roger Hilfiker、University of Applied Sciences of Western Switzerland

Home-based Motor Imagery Intervention for the Improvement of Gait Stability in Elderly Persons. A Cross-over Feasibility Study.

Gait stability is reduced as early as from age 40 to 50. Gait stability can be improved in patients with neurological diseases or in healthy elderly persons with exercises.

There is evidence that mental practice, also called motor imagery, the imagination of performing a movement, can also improve an activity or balance. The effective performance and the imagination of a task activates some overlapping central areas and neural networks, which might explain the improvements after motor imagery.

The investigators set out to test the feasibility of such a study using an open label randomized cross-over trial including 32 persons aged 40 years or more. The primary aim is to evaluate whether the instructions are clear, the intervention and the study procedures are acceptable and to assess the proportion of participants withdraw from the study (drop outs). Secondary aims are the assessment of between group differences in the changes of the gait stability.

研究概览

地位

未知

条件

详细说明

Gait stability is reduced as early as from age 40 to 50. Gait stability can be improved in patients with neurological diseases or in healthy elderly persons with exercises.

There is evidence that mental practice, also called motor imagery, the imagination of performing a movement, can also improve an activity or balance. The effective performance and the imagination of a task activates some overlapping central areas and neural networks, which might explain the improvements after motor imagery.

These "non-physical kind of training" modalities could be used in patients who are immobilized temporarily (bedridden because of non-chronic disease, infection etc.), or in those who are not allowed to charge their leg normally (e.g. postoperative phase of joint replacement or fractures), or it can be used in combination with physical exercises, or in the preparation of the physical exercise training (either skilling up phase or as a preparation to increase safety of physical exercises). In persons above 40 years of age, motor imagery could provide a sound exercise modality for tasks that are not easy to perform with real performance. For example, walking on slippery underground such as ice, walking on a small trail in some altitude, avoiding running dogs or cats on a sidewalk, or catching up after stumbling can be either difficult to exercise in reality or might be too dangerous in reality. Imaging one's performance in such difficult environments or situations might lead to better gait stability, improved reactions in these situations and thus probably to reduced falls frequency.

Gait stability can be estimated with the local dynamic stability, which is based on chaos theory, i.e. the maximal Lyapunov exponent, is strongly influenced by the sensorimotor balance system and is widely used for measuring gait stability.

In the future, the investigators plan a large scale randomized open label cross-over study to test whether nine sessions of motor imagery improve walking stability, measured with the Lyapunov Exponent.

To prepare this future study, the investigators set out to test the feasibility of such a study with a feasibility study using an open label randomized cross-over trial including 32 persons aged 40 years or more. The primary aim is to evaluate whether the instructions are clear, the intervention and the study procedures are acceptable and to assess the proportion of participants withdraw from the study (drop outs). Secondary aims are the assessment of between group differences in the changes of the gait stability.

研究类型

介入性

注册 (预期的)

32

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

    • Valais
      • Leukerbad、Valais、瑞士、3954
        • 招聘中
        • Hochschule für Gesundheit HES-SO Valais-Wallis
        • 接触:
          • Roger Hilfiker
          • 电话号码:0041796883490

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

40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:

  • 40 years old or older
  • Able to walk bout 100 meter, with or without walking aids, but without the help of a person or an ambulator

Exclusion Criteria:

  • Walking with an ambulator (Rollator)
  • No able to understand German

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:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control
Participants will be allowed to perform all usual activities but should refrain from performing the motor imagery exercises.
实验性的:Motor imagery

The motor imagery intervention is a non-pharmacological and non-invasive treatment often used in sport, music, or physical rehabilitation (Schuster, Hilfiker et al. 2011). Proposed tasks to be imagined by the participants are for example:

"Imagine you are walking on ice. During the first steps, you are slipping quite often, but as you walk on, your steps become more stable and you walk without problems over the ice. Try to imagine how you react when you slip on ice, how you try not to fall and to continue to walk normally" The motor imagery intervention will be performed independently by the study participants at home without supervision three times a week for three weeks.

The motor imagery intervention is a non-pharmacological and non-invasive treatment often used in sport, music, or physical rehabilitation (Schuster, Hilfiker et al. 2011). Proposed tasks to be imagined by the participants are for example:

"Imagine you are walking on ice. During the first steps, you are slipping quite often, but as you walk on, your steps become more stable and you walk without problems over the ice. Try to imagine how you react when you slip on ice, how you try not to fall and to continue to walk normally" The motor imagery intervention will be performed independently by the study participants at home without supervision three times a week for three weeks.

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
Composite Endpoint "feasibility"
大体时间:Immediately after the end of the both Intervention periods (week 6)

Combination of the following three parts:

Part 1: one question about the understandability of the exercises Part 2: one question about the acceptability of the whole study process Part 3: Finishing the whole study: Did the participant finish the whole study, i.e. all three test sessions and at least some session of motor imagery exercises (based on the exercise calendar)?

Immediately after the end of the both Intervention periods (week 6)

次要结果测量

结果测量
措施说明
大体时间
Adherence to the motor imagery exercises
大体时间:Immediately after the end of the first intervention periods (week 3)
The adherence to the motor imagery exercises will be assessed with a exercise calendar with a sheet for each of the three weeks. On each day of the calendar the exercises were shortly described and the participants can just check whether he has done that exercise and can state how many minute he or she has exercises that day (only motor imagery exercises).
Immediately after the end of the first intervention periods (week 3)
Change in the Lyapunov Exponent in the three acceleration axes "anterio-posterior", "medio-lateral" and "vertical"
大体时间:Immediately after the end of the first period (week 3)

The "first" endpoint for effectiveness is the change in the Lyapunov Exponent in the three acceleration axes "anterio-posterior", "medio-lateral" and "vertical". The Lyapunov Exponent is calculated based on the 4 times 30 meter walk test in normal speed.

For these tests, the participants wear normal clothes and normal shoes (same shoes at all three test sessions). The test will be performed in a 35 meter long corridor.

The participant starts walking with his normal speed, walks 30 meters and stops. He turns 180°, waits ten seconds and starts walking again the 30 meters. He repeats this until he has four series of 30 meters. The data will be stored after each participant on a portable computer in coded form. The Lyapunov Exponent is then calculated later in R (statistical software) and the mean over all four series is taken.

Immediately after the end of the first period (week 3)

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:Roger Hilfiker、School of Health Sciences, HES-SO Valais-Wallis

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

2016年2月1日

初级完成 (预期的)

2021年6月1日

研究完成 (预期的)

2021年9月1日

研究注册日期

首次提交

2016年2月7日

首先提交符合 QC 标准的

2016年2月23日

首次发布 (估计)

2016年2月29日

研究记录更新

最后更新发布 (实际的)

2019年8月6日

上次提交的符合 QC 标准的更新

2019年8月5日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • PHYVS2016-1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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