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临床试验/NCT05316896
NCT05316896Unknown不适用

Investigation of the Efficacy of Internal and External Perturbation Exercises on Functional Parameters in Stroke Rehabilitation

Medipol University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年4月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Change from baseline in balance on the Timed Up and Go Test at 4 weeks

研究概览

简要总结

Stroke is a serious medical condition that causes the death of brain cells as a result of blockage of a blood vessel that feeds the brain (ischemic stroke) or bleeding in or around the brain (hemorrhagic stroke). People who have had a stroke have a higher risk of falling than people who have not had a stroke at the same age. Lack of balance control not only increases the risk of falling, but also leads to fear of falling and reduces the integration of people with stroke into society.

The central nervous system uses two main postural strategies to maintain and restore balance when perturbed. These; are anticipatory and compensatory postural adjustments. Anticipatory postural adjustments control the position of the body's center of mass by activating the trunk and leg muscles prior to a forthcoming body perturbation, thus minimizing the risk of loosing equilibrium. Compensatory postural adjustment are initiated by sensory feedback signals and serve as a mechanism of restoration of the position of the center of mass after a perturbation has already occurred.

In this study, the investigators aimed to determine which one is more effective, unlike previous studies that showed that internal and external perturbation exercises were effective when applied together. For this purpose, the researchers the planned to investigate and compare the effects on balance, performance, activity and participation in individuals to whom only internal perturbations were applied and only external perturbations were applied.

The participants will be divided into 2 groups, as Group A and Group B, with 10 participants in each group, in a randomized controlled manner.

Treatment Protocol:

Conventional treatment was applied to participants included in both groups for 4 weeks, 5 days a week, 40-minute sessions. In addition to conventional treatment, 30 minutes of perturbation-based balance training was given to the participant in the study. Participants in Group A received internal perturbation training, and participants in Group B received external perturbation training.

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 (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral stroke history
  • Adults with chronic stroke (>6 months poststroke)
  • Ability to stand for at least 30 seconds without support

排除标准

  • Those with Parkinson's disease, amputation, severe osteoporosis
  • Those with uncontrolled diabetes, hypertension
  • In addition to stroke, the presence of any problem that may adversely affect balance
  • Areas below 24 in the mini mental state test

结局指标

主要结局

Change from baseline in balance on the Timed Up and Go Test at 4 weeks

时间窗: baseline and 4 weeks

For the timed up and go test, the patient gets up from the chair without arm support, walks 3 meters, returns and sits back in the chair. The total time it takes to complete the test is recorded in seconds using a stopwatch. The evaluation results are valid as they include maneuvers used in daily life. Individuals with independent balance and mobility skills complete the test in less than 10 seconds, individuals who complete it in more than 30 seconds are dependent on many activities and mobility skills in daily life.

Change from baseline in balance on the One Leg Standing Test at 4 weeks

时间窗: baseline and 4 weeks

One foot is lifted so that it does not touch the other leg and the time is measured with a stopwatch. At first the eyes are open. When the eye open test is completed, the test is done with the eyes closed and it is expected that he can maintain his balance for 30 seconds. An imbalance is considered if the lifted leg touches the other leg, the foot touches the floor, bounces or bounces, or anything in the environment is touched for support.

Change from baseline in balance 10-meter Walking Test at 4 weeks

时间窗: baseline and 4 weeks

In this test, the person is asked to walk at his own normal pace in a pre-measured 10-meter area. The time starts when the person's foot is on the starting line and ends when they cross the finish line. Two measurements are made and the best value is recorded in meters/second.

Change from baseline in dynamic and static balance on the Berg Balance Scale at 4 weeks

时间窗: baseline and 4 weeks

Berg balance scale is a valid and reliable test that measures both dynamic and static balance. It evaluates the body's ability to maintain position during 14 different activities in which the support surface decreases and the center of gravity changes, by observation. It is scored between 0-4 points, while at 0 the activity cannot be completed, at 4 it is completed independently. The total score is 56. If the score obtained at the end of the test is between 0-20, it is interpreted as poor balance skills, between 21-40 as acceptable balance and between 41-56 as advanced balance skills.

次要结局

  • Change from baseline in ambulation ability on the Functional Ambulation Classification (FAS) at 4 weeks(baseline and 4 weeks)
  • Change from baseline in balance on the 4-Step Climbing Test at 4 weeks(baseline and 4 weeks)
  • Motor development in stroke patients on the Brunnstrom Hemiplegia Recovery Staging at baseline(baseline)
  • Change from baseline in quality of life on the Stroke Impact Scale at 4 weeks(baseline and 4 weeks)
  • Change from baseline in daily life activities on the Nottingham Health Profile at 4 weeks(baseline and 4 weeks)
  • Assessment method for spasticity on the Modified Ashworth Scale at baseline(baseline)
  • Change from baseline in level of disability on the Barthel Index at 4 weeks(baseline and 4 weeks)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nagihan Bodur

Physiotherapist

Medipol University

研究点 (2)

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