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临床试验/NCT03945006
NCT03945006已完成不适用

An Investigation of Balance, Trunk Impairment, and Fear of Falling in Multiple Sclerosis Patients With Incontinence

Ankara Yildirim Beyazıt University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年3月25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
36
试验地点
1
主要终点
Assessment of the Severity of Incontinence

研究概览

简要总结

The aim of the present study was to examine balance, trunk impairment, and fear of falling in MS patients with incontinence. Clinical symptoms of the MS patients are heterogenous, and they vary according to the lesion levels and the duration and the type of the disease. In the neurologic group,especially in MS patients, incontinence is observed even at early stages.

Pelvic floor muscles contribute to continence by stabilizing the bladder neck and increasing the intraurethral pressure. Furthermore, they mechanically support the spine and the pelvis.This mechanical support is attained through an increase in sacroiliac joint stiffness and intra-abdominal pressure changes, which are important for spinal control. Along with incontinence, this mechanical support deteriorates resulting in some problems. By this way, postural function of pelvic floor muscles may alter in individuals with incontinence, and thus, lumbopelvic stabilization may be negatively affected. In addition, the activity of trunk muscles changes in individuals with incontinence, which may result in spinal movement and affect the posture. Therefore, balance disorders may develop. Postural sways caused by balance disorders and the decrease in postural corrections have been listed among risk the factors associated with falling.

When literature is examined, there exists no study examining the effects of incontinence on balance, trunk impairment, and fear of falling in MS patients. For all these reasons, investigators think that incontinence in MS patients has an effect on balance, trunk impairment, and fear of fall.

详细描述

This study was aimed to investigate balance, trunk impairment, and fear of falling in MS patients with and without incontinence.

The study was conducted in 35 MS patients with an age range of 24-58 years. The patients were divided into two groups based on the occurrence of incontinence. A neurologic examination was performed using the EDSS by a neurologist.

Incontinence was measured with the Incontinence Severity Index (ISI), balance was measured with a Technobody® stabilometric platform, and fear of falling was measured with the Falls Efficacy Scale (FES).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
24 Years 至 58 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Multiple Sclerosis Disease
  • The level of disability should be between 0.5-4 according to EDSS
  • having a score of 24 or more in the Mini Mental Status Test

排除标准

  • Patients with acute attacks (six months prior to the study)
  • Mini-Mental State Examination (MMSE) score of less tahn 25 points
  • History of shoulder injury, surgery, medical problems or other neurological disorders in any of the participants

结局指标

主要结局

Assessment of the Severity of Incontinence

时间窗: 3 week

The Incontinence Severity Index (ISI) was used to assess the MS patients' incontinence severity. The first item is scored between 1 and 4 and the second item is scored between 1 and 3. The total score is calculated by the multiplication of these two answers. The index score is classified as 1-2 slight, 3-6 moderate, 8-9 severe, and 12 very severe.

次要结局

  • Trunk Impairment Assesment(3 week)
  • Static Balance Assessment(3 week)
  • Fear of Falling(3 week)

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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