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临床试验/NCT04455607
NCT04455607已完成不适用

The Influence of a Perturbation Training on Balance Recovery of Old Adults - a Randomized Controlled Trial

Soroka University Medical Center6 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
6
主要终点
The step recovery thresholds and brain imaging (MRI)

研究概览

简要总结

Falls are major contributors for immobility and independency. Most falls in older adults occur during walking after a sudden unexpected loss of balance. It was well-established that balance can be improved by performance of a training program that provides perturbation (unexpected perturbations of balance). The main aim of the current study is to investigate the effects of two perturbation-training methods: 1) random perturbation training; vs. 2) block (non-random) perturbation training. We also aim to explore brain area's (as measured by MRI) that are related to balance function in older adults.

We hypothesize that response to an unexpected loss of balance is the balance responses will be improved in both training methods, but more in the random training method. We also hypothesize that brain function as seen in MRI will be improved in both training methods, more in the random training method.

As far as we know, there is a lack of studies investigating the learning effect of random vs. block non-random training on balance recovery responses while walking and exposure to unexpected loss of balance and on brain function.

详细描述

Goals:

  1. Determine the relationship between gait stability (as measured in the Lab) and brain function (MRI) in 50 old (70 years old and over) and 10 young adults (20-40 years old) that represent heathy brain.
  2. To determine which of the training intervention methods (25 older adults that participate in random training vs. 25 older adults that participate in block non-random training) are more beneficial for balance recovery responses and for improved brain function.

Methods: This study is a clinical investigation study. First stage - Individuals that show an interest in participating in the study will be exposed to a brief interview before further testing is performed to see if they fit the inclusion-exclusion criteria. Individuals who pass the interview a screening, and physical examination and the additional questionnaires and functional tests described below.

Second stage - Testing different motor learning paradigms for improving balance recovery ability: A convenience sample of 60 healthy subjects (10 young's, 50 older adults) will be recruited. After testing their clinical balance performance (Berg balance test, 6-minutes' walk and get up and go) and cognitive function (MOCA), All testing will occur on a specific motor-driven surface perturbation treadmill (BaMPer). The Gait protocol will include about 10-20 minutes of comfortable pace walking, than progressive unexpected surface perturbations will be added. The same protocol will be performed with during standing condition. Subjects will also walk on the treadmill without perturbations. The order of the different test conditions will be randomized.

Outcome measures: The stepping threshold as measured by the distance of the platform movements in centimeters will be measured. Quantitative parameters of the compensatory stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive parameters of the stepping strategy after perturbation

研究设计

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

入排标准

年龄范围
70 Years 至 120 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 70 years and older (with the young age of 20-40)
  • able to walk independently (without utilities treadmill or stick);
  • Be asked to invent a medical certificate which allows participation in exercise that requires walking twice a week.

排除标准

  • suffering from ischaemic heart disease which limits exercise and COPD and blood pressure is not controlled;
  • not suffering serious vision problems;
  • does not suffer from this problem: (a score of 24 or higher on MOCA);
  • a year after analyzing the type of hip replacement or knee or broken extremities;
  • Does not suffer any neurological diseases or stroke.

结局指标

主要结局

The step recovery thresholds and brain imaging (MRI)

时间窗: 60 minute

The stepping threshold as measured by the distance of the platform movements in centimeters will be measured. Quantitative parameters of the compensatory stepping/ and motor ability (i.e., step reaction time, step time, step length), descriptive parameters of the stepping strategy after perturbation (i.e., arm responses, upper body responses, leg step threshold and fall threshold). In addition we will be testing the correlation between brain activity using brain imaging in both to find whether improvement in motor function are correlated with brain function and anatomy.

次要结局

  • Postural stability(10 minutes)
  • Voluntary step test(6 minutes)
  • Berg Balance test(10 minutes)
  • kinematics of walking(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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