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临床试验/NCT05325359
NCT05325359Unknown不适用

Validity and Reliability of L Test in Persons With Multiple Sclerosis

Firat University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月7日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Timed Get Up and Go Test

研究概览

简要总结

Multiple Sclerosis (MS), a chronic inflammatory disease of the central nervous system, is a disease characterized by myelin, oligodendrocyte and axon damage [1]. Research continues on the autoimmune, infectious, environmental, vascular and genetic origins of this disease, which affects approximately 2.5 million people in the world and is seen 2-3 times more in women than in men. Although the signs and symptoms of the disease vary according to the location of the lesion; Loss of balance and strength, spasticity, sensory disturbances, fatigue, ataxia, autonomic dysfunction, and decreased visual acuity is frequently observed.

There are no studies in the literature investigating the validity and reliability of this test in individuals with MS. Reliability is population-specific and it is important to investigate the reliability of the L test in MS patients. Therefore, the aim of our study is to reveal the test-retest reliability and validity of the L test.

详细描述

General Information about the Research, Rationale and Objectives:

Multiple Sclerosis (MS), a chronic inflammatory disease of the central nervous system, is a disease characterized by myelin, oligodendrocyte and axon damage [1]. Research continues on the autoimmune, infectious, environmental, vascular and genetic origins of this disease, which affects approximately 2.5 million people in the world and is seen 2-3 times more in women than in men [1, 2]. Although the signs and symptoms of the disease vary according to the location of the lesion; Loss of balance and strength, spasticity, sensory disturbances, fatigue, ataxia, autonomic dysfunction, and decreased visual acuity are frequently observed [1].

Abnormalities and losses in balance management are frequently seen in individuals with MS [3-6] . This abnormality, together with other risk factors, increases the risk of falling [7] and causes limitations in patients' activities of daily living. Studies on balance problems in elderly individuals are frequently investigated in the literature. However, the frequency of falls in this population was found to be 1.5 falls per year [8], while another study investigating individuals with MS found an average of 9 falls per year [7]. In order to develop fall prevention or reduction strategies, it is necessary to evaluate different aspects of motor impairment and to accurately identify factors contributing to falls [9-11]. Since falls among MS patients have a multifactorial etiology, multiple evaluations are necessary to explore the balance problem.

Although various scales have been developed to evaluate the functional level of MS patients [12, 13], the use of frequently applied scales in this patient group allows the results to be compared with other studies and other pathologies. In addition, the use of frequently applied scales does not require special training of raters. Previous studies have used the Berg Balance Scale, the Functional Reach Test, the Timed Get Up and Walk test, and general measures of fall risk (eg, questioning the date of fall) [14-16]. These tests primarily assess the ability to walk forward, turn back, and take a step.

The reliability of the TUG in people with MS has ranged from 'good' to 'excellent' [17,18], but the TUG is only an opportunity for unilateral disorders to turn in a preferred direction [19]. Thus, despite good reliability and validity, TUG currently has limitations in MS that can only be overcome by adding complex and potentially excessively expensive instrumentation. The L test is a modification of the TUG that extends the walking distance from 6 to 20 m and also requires participants to make both clockwise and counterclockwise turns. Therefore, it may have limited sensitivity and the potential to overcome ceiling effects. The L test was originally designed for individuals following lower limb amputation and has since been evaluated in stroke and hospitalized elderly subjects [19-21]. In all three studies, the L test showed good reliability and also showed good correlation with the TUG. The aim of this study is to evaluate the L test in terms of test/retest reliability and concurrent validity with TUG in individuals with MS. There are no studies in the literature investigating the validity and reliability of this test in individuals with MS. Reliability is population specific and it is important to investigate the reliability of the L test in MS patients. Therefore, the aim of our study is to reveal the test-retest reliability and validity of the L test.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for volunteers; Individuals with relapsing-remitting type MS, who are between 18-65, EDSS scores between 1 ≤ and ≤ 5.5, individuals who score 24 and above in Mini Mental State Examination and who can walk a minimum of 20 m independently will be included.

排除标准

  • In addition, exclusion criteria for volunteers; Severe spasticity of the lower extremities (Ashworth score 3 or 4), having an acute MS attack or a history of an attack in the last 1 month, having an orthopedic or systemic problem that would prevent participation in the tests, having another neuromuscular disorder other than MS, visual involvement or diplopia, and is that he has a cardio-pulmonary problem that will prevent him from participating in the tests.

结局指标

主要结局

Timed Get Up and Go Test

时间窗: 1 week

It is applied to assess the balance and fall risk of individuals. The patient is first asked to sit leaning on the chair. The patient is then asked to stand up, walk with regular steps for a predetermined distance of 3 meters, return at the end of 3 meters and sit in a chair. During the test, the patient's walking time is recorded in seconds with a stopwatch. The test was repeated three times and the average value will be recorded

L test

时间窗: 1 week

It is an expanded version of the TUG and is designed to assess advanced functional ambulation with more detail available elsewhere. It is recorded when the participant gets up from the chair, walks 3 m to a cone, turns 90° to the right, continues to walk 7 m to the next cone, turns 180° left around the cone, then returns to the chair the same way. The test time is recorded, starting with the word "go" and ending with the participant's back touching the back of the chair.

次要结局

  • 3-meter Walk Back Test(1 week)
  • 10-Meter Walk Test (10MeWT)(1 week)

研究者

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

Furkan BİLEK

Lecturer

Firat University

研究点 (1)

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