NCT06648499|Not Yet Recruiting
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Sponsor study identifier
observational
46
0 countries
N/A
Study Start
October 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 18, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 16, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 16, 2024
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2024
Actual (reported)October 18, 2024
Actual (reported)October 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 18, 2024
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December 16, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
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.
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.
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.
Serhat Güler MD
Istanbul University - Cerrahpasa
First Submitted
October 17, 2024
First Posted
October 18, 2024
Study Start
October 28, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 18, 2024
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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 16, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 22, 2024
Record last verified: 2024-10
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