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

NCT ID: NCT06648499

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-28
• Study Completion Date: 2024-12-16

Brief Summary

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.

Conditions

Pediatric-Onset Multiple Sclerosis (POMS)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pediatric-Onset Multiple Sclerosis Group

Individuals in the POMS group will be evaluated in terms of lower extremity muscle strength, physical activity, exercise capacity, balance, quality of life, and fatigue.

Evaluation of lower extremity muscle strength, physical activity, exercise capacity, balance, quality of life, and fatigue in POMS

Intervention Type: OTHER

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 Scale for fatigue. All assessments will be completed on the same day and will not be repeated after a certain period of time.

Healthy Controls

Individuals in the control group will be evaluated in terms of lower extremity muscle strength, physical activity, exercise capacity, balance, quality of life, and fatigue.

Evaluation of lower extremity muscle strength, physical activity, exercise capacity, balance, quality of life, and fatigue in healthy controls

Intervention Type: OTHER

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 will be completed on the same day and will not be repeated after a certain period of time.

Interventions

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 Scale for fatigue. All assessments will be completed on the same day and will not be repeated after a certain period of time.

Intervention Type: 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 will be completed on the same day and will not be repeated after a certain period of time.

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Yonca Zenginler Yazgan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serhat Güler MD

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Central Contacts

Yonca Zenginler Yazgan PhD

Role: CONTACT

yoncazenginler@gmail.com

+905326006294

Zelal Apaydın MSc

Role: CONTACT

apaydinzelal@gmail.com

+905395583859

Other Identifiers

IUC-2024-152

Identifier Type: -

Identifier Source: org_study_id