Five Times Sit-To-Stand Test for Patients with Pediatric-Onset Multiple Sclerosis

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other Evaluation of lower extremity muscle strength, physical activity, exercise capacity, balance, quality of life, and fatigue in POMS
  The demographic information of the patients will be taken with the form prepared for the people in this group. Patients 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 S
• Other Evaluation of lower extremity muscle strength, physical activity, exercise capacity, balance, quality of life, and fatigue in healthy controls
  The demographic information of the healthy controls will be taken. Healthy controls 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. All assessments wi

Primary outcome measures

• Five Times Sit-To-Stand Test performance [Time frame: baseline]

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• Volunteer to participate
• Being diagnosed with pediatric onset multiple sclerosis
• Being between the ages of 15-22
• EDSS ≤6

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06648499 · IUC-2024-152

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗