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

NCT06648499 | Not Yet Recruiting

• 1 other identifier: IUC-2024-152
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pediatric-Onset Multiple Sclerosis (POMS)

Keywords

lower extremity muscle strength; pediatric-onset multiple sclerosis; five times sit-to-stand test; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Five Times Sit-To-Stand Test performance

  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.

  baseline

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

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

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.

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

Interventions

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

Pediatric-Onset Multiple Sclerosis Group

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

Healthy Controls

Eligibility Criteria

• Age: 15 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The sample size was calculated based on the total fatigue scores in patients with pediatric-onset MS and healthy controls of the same age group, using the child form of the PedsQL Multidimensional Fatigue Scale as employed by Gravesande et al., with a 0.05 margin of error and 80% power. According to this calculation, it was seen that 25 patients with pediatric-onset MS and 13 healthy individuals who were matched for age and sex (2:1 distribution) should be included in our study. ). Considering the possibility of dropouts, we planned to include 30 patients with pediatric-onset MS and 16 healthy controls, making a total of 46 participants, with an additional 20% added to each group.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Interventions

Exercise; Quality of Life

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Serhat Güler MD

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

Yonca Zenginler Yazgan PhD

CONTACT

+905326006294; yoncazenginler@gmail.com

Zelal Apaydın MSc

CONTACT

+905395583859; apaydinzelal@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: October 28, 2024
• Primary Completion: November 18, 2024
• Study Completion: December 16, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10