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临床试验/NCT06166004
NCT06166004已完成不适用

The Effects of Balance Trainer-Based Training on Balance and Trunk Control in Stroke Survivors

Ankara Yildirim Beyazıt University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年8月23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
42
试验地点
2
主要终点
Trunk Imapirment Scale

研究概览

简要总结

The trunk is reference and key region of body in terms of both mobility and stability. Sufficient stability in the trunk is essential for the execution of intentional extremity movements. Therefore, even in conditions with significant extremity impairment, such as stroke, trunk functionality is a crucial factor affecting the success of treatment. The Balance Trainer is a device used for balance rehabilitation. However, the patient's use of the trunk is also intense during trunk exercises. The aim of the study is to contribute to the literature by examining the development of trunk control, a component of both balance and stability, through the use of the Balance Trainer.

详细描述

Stroke is one of the leading causes of death in adults and significantly contributes to severe disability. Balance problems are among the most common issues following a stroke, affecting the patient's ability to sit, stand, transfer, and walk, thereby posing a risk of falls. Balance rehabilitation can be instrumental in addressing these challenges. For instance, clinicians may decide to allocate more time to safe transfers or wheelchair skills for individuals with a Berg Balance Scale (BBS) score below 12. Conversely, those scoring 29 or higher on the BBS may warrant an increase in the intensity and duration of walking training, as they are likely to progress to community-appropriate walking speeds.

The trunk, located at the body's center, plays a crucial role in organizing postural control and balance reactions. A healthy trunk is essential for the successful execution of both lower and upper extremity functions. Trunk control is necessary to provide a stable support base during the execution of lower and upper extremity movements, requiring active involvement of the trunk in daily life activities such as reaching.

The Balance-Trainer is a technology-based biofeedback-controlled system used in individuals with Multiple Sclerosis, Stroke, Muscle Diseases, and geriatric populations. The device includes balance exercises involving weight shifting in different directions through games like Collect Apples, Outline, Paddle War, and Evaluation of Movement. Reviewing the literature reveals that exercise devices incorporating virtual reality are effective in improving balance.

The research, designed as a prospective study with two parallel groups, aims to investigate the effects of balance training with the Balance-Trainer (BT) on trunk control, balance, and fall risk in stroke patients. The hypothesis is that balance training with BT will positively impact trunk control and balance. The study population consists of patients undergoing treatment for stroke (ICD.10 G.81 Hemiplegia) at Ankara City Hospital Physical Therapy and Rehabilitation Hospital.

Volunteers meeting the inclusion criteria from stroke patients receiving treatment at Ankara City Hospital Physical Therapy and Rehabilitation Hospital will be enrolled in the research. Participants involved in the study will continue their standard rehabilitation program. Those directed by their physician for BT will be included in the study group, while stroke patients voluntarily not receiving balance training with BT during their stroke clinic treatments will be included in the control group.

研究设计

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

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

  • Having the ICD-10 diagnosis code G.81 Hemiplegia
  • At least 3 weeks having passed since the diagnosis (Subacute and later periods)
  • Being 18 years of age or older
  • Having a Berg Balance Score between 21-40 (indicating an acceptable balance)

排除标准

  • Having a known additional neurological or orthopedic problem that could affect balance
  • Not being cognitively able to understand and perform exercises
  • Having a diagnosis date that is more than 2 years from the initial evaluation date

结局指标

主要结局

Trunk Imapirment Scale

时间窗: Baseline and 3 weeks later

It is a standardized scale designed for assessing the trunk after a stroke. It consists of three sections: static sitting balance, dynamic sitting balance, and coordination, with a maximum score of 23. In our research, it will be utilized to evaluate patients' trunk control after a stroke.

Berg Balance Scale

时间窗: Baseline and 3 weeks later

This is a simple and safe balance test designed to measure an individual's ability to maintain balance while performing functional tasks. The person is asked to perform 14 tasks, and scores are given based on the completion of each task. A score of 0 is assigned when the activity is not performed at all, while a score of 4 is given when the activity is completed independently. The highest possible score is 56, with 0-20 indicating balance impairment, 21-40 suggesting an acceptable balance, and 41-56 indicating good balance.

次要结局

  • Functional Ambulation Category(Baseline and 3 weeks later)
  • Falls Efficacy Scale-International(Baseline and 3 weeks later)
  • Functional Independence Measure(Baseline and 3 weeks later)

研究者

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

Murat Akıncı

Principal Investigator

Ankara City Hospital Bilkent

研究点 (2)

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