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临床试验/NCT06648499
NCT06648499尚未招募不适用

Five Times Sit-To-Stand Test for Patients with Pediatric-Onset Multiple Sclerosis: Performance and Explanatory Factors

Istanbul University - Cerrahpasa (IUC)0 个研究点目标入组 46 人开始时间: 2024年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
46
主要终点
Five Times Sit-To-Stand Test performance

研究概览

简要总结

Transitioning from a sitting to a standing position is a movement essential for maintaining physical independence and functional mobility, and is necessary for performing many activities in daily life. Lower extremity muscle strength is considered the most critical factor reducing the capacity to perform the sit-to-stand movement. A study concluded that the Five-Times Sit-to-Stand test in patients with multiple sclerosis (MS) is multifactorial and is associated with walking speed and fatigue. Another study using the same test concluded that lower extremity capacity is reduced compared to healthy controls and is associated with balance, functional mobility, gait, and fatigue.

Pediatric-onset MS, occurring in patients under the age of 18, accounts for approximately 3-10% of all multiple sclerosis cases and is increasingly recognized in many parts of the world. According to our research, no studies have been found that demonstrate the extent of lower extremity involvement in patients with pediatric-onset MS compared to their healthy controls. Our aim is to evaluate the performance of the Five-Times Sit-to-Stand test in patients with pediatric-onset MS, compare it with healthy controls, and examine its relationship with physical activity, exercise capacity, functional mobility, quality of life and fatigue.

详细描述

In addition to visual, sensory, motor, and coordination impairments, cognitive problems, pain, and fatigue may occur in patients with pediatric-onset MS. Studies have reported that patients with pediatric-onset MS tend to participate in less physical activity and have lower exercise capacity compared to their healthy peers. Lower extremity functional capacity is impaired in most patients with MS, and the high prevalence of walking disorders is an example of this. Therefore, assessing lower extremity capacity and identifying modifiable determinants appears to be important. Moreover, a detailed assessment of lower extremity parameters in MS patients is crucial for determining appropriate rehabilitation programs. Transitioning from a sitting to a standing position is necessary for performing many activities in daily life. Assessment of lower extremity muscle strength using the sit-to-stand movement enables the development of preventive interventions in the early stages of the disease.

Our aim is to evaluate the performance of the Five-Times Sit-to-Stand (FTSTS) test in patients with pediatric-onset MS, compare it with healthy controls, and examine its relationship with physical activity, exercise capacity, functional mobility, quality of life, and fatigue. Under the supervision of a physical therapist, participants will be assessed using the FTSTS test to evaluate lower extremity muscle strength, the Godin Leisure Time Exercise Questionnaire (GLTEQ) for physical activity, the 2-Minute Walk Test (2MWT) for exercise capacity, the Timed Up and Go (TUG) Test for functional mobility, the Pediatric Quality of Life Inventory (PedsQL) for quality of life, and the PedsQL Multidimensional Fatigue Scale for fatigue.

It is planned to include 30 patients with pediatric-onset MS and 16 healthy controls, making a total of 46 participants in this study. The Shapiro-Wilk test will be employed to assess whether the data adhere to a normal distribution. Differences between groups will be analyzed using the independent sample t-test for normally distributed variables and the Mann-Whitney U test for non-normally distributed variables. The Chi-square test will be used to compare categorical variables. Intercorrelations among FTSTS and other variables will be calculated using Pearson or Spearman correlation analysis. This will be the first study to evaluate the performance of the FTSTS test in patients with pediatric-onset MS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteer to participate
  • Being diagnosed with pediatric onset multiple sclerosis
  • Being between the ages of 15-22

排除标准

  • Having another diagnosis in addition to the diagnosis of pediatric-onset multiple sclerosis
  • Having had an attack or received corticosteroid treatment 3 months before participating in the study

结局指标

主要结局

Five Times Sit-To-Stand Test performance

时间窗: baseline

The Five Times Sit-To-Stand Test is considered to be a valid, reliable, easy, and rapid method for evaluating lower extremity muscle strength in patients with MS. The time taken to complete five repetitions of the sit-to-stand movement will be measured as part of the test. Participants, seated in a chair without arm supports with their arms crossed over their chest, were instructed to stand up and sit down five times and to perform the test as quickly as possible. No encouragements will be given during the test. Prior to commencing, the participant will be instructed on how to perform the test, and an untimed practice trial will be conducted.

次要结局

  • Pediatric Quality of Life Inventory(baseline)
  • PedsQL Multidimensional Fatigue Scale(baseline)
  • The Godin Leisure Time Exercise Questionnaire(baseline)
  • 2-Minute Walk Test(baseline)
  • Timed Up and Go Test(baseline)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yonca Zenginler Yazgan

Associate Professor

Istanbul University - Cerrahpasa (IUC)

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