Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648499
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Five Times Sit-To-Stand Test for Patients with Pediatric-Onset Multiple Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Five Times Sit-To-Stand Test for Patients with Pediatric-Onset Multiple Sclerosis Performance and Explanatory Factors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None