Five Times Sit-To-Stand Test for Patients with Pediatric-Onset Multiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-22
SponsorIstanbul University - Cerrahpasa
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Volunteer to participate
Being diagnosed with pediatric onset multiple sclerosis
Being between the ages of 15-22
EDSS ≤6
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Evaluation of lower extremity muscle strength, physical activity, exercise capacity, balance, quality of life, and fatigue in POMS
Other interventionThe 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.
Evaluation of lower extremity muscle strength, physical activity, exercise capacity, balance, quality of life, and fatigue in healthy controls
Other interventionThe 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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Pediatric-Onset Multiple Sclerosis Group1 intervention
Group B: Healthy Controls1 intervention
Trial outcomes
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.
Time frame
baselineSecondary outcomes
1
Pediatric Quality of Life Inventory
Quality of life will be assessed using the Pediatric Quality of Life Inventory. This inventory contains two parallel forms, allowing both the child and the family to respond, and it is composed of sections on physical functioning, emotional functioning, social functioning, and school functioning. The total score is calculated on a scale from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame
baseline2
PedsQL Multidimensional Fatigue Scale
The fatigue levels of participants will be assessed using the PedsQL Multidimensional Fatigue Scale. The scale is a valid and reliable instrument for evaluating fatigue in pediatric populations. It consists of 18 items and covers 3 domains of fatigue (general, sleep/rest, and cognitive). Higher scores indicate greater levels of fatigue.
Time frame
baseline3
The Godin Leisure Time Exercise Questionnaire
The Godin Leisure Time Exercise Questionnaire (GLTEQ) will be used to evaluate physical activity levels. GLTEQ is a self-reported questionnaire that is valid for PwPOMS measuring participants' physical activity behaviors. The first question inquires about the frequency of light, moderate, and vigorous physical activities that patients engage in for more than 15 minutes during a week. The second question of the survey asks about the frequency of activities performed in a week that are intense enough to induce sweating.
Time frame
baseline4
2-Minute Walk Test
The 2-minute walk test (2MWT) is used to assess exercise capacity. The 2MWT has been reported to be a reliable and valid measure in PwMS. Participants will be instructed to cover as much distance as possible in 2 minutes on a 30-meter walking path in a single trial, and the total distance walked was recorded in meters.
Time frame
baselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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