Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880745
Status:
COMPLETED
Last Update Posted:
2023-05-30
First Post:
2023-05-15
Brief Title:
The Effect of the Level of Hand Fatigability on Multiple Sclerosis on General Fatigue and Functionality
Sponsor:
Pamukkale University
Organization:
Pamukkale University
Study Overview
Official Title:
The Effect of the Level of Hand Fatigability on Multiple Sclerosis on General Fatigue and Functionality A Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to investigate the effect of the level of hand fatigability on general fatigue and functionality by comparing Relapsing-Remitting Multiple Sclerosis individuals with age and sex-matched healthy individuals 23 RRMS and 23 healthy people mean age 4008 21 females mean time since diagnosis 943 years mean Expanded Disability Status Scale 323 were included in the study To examine participants fatigability level for gross and pinch-grip Dynamic and Static Fatigue Index for manual dexterity and functionality level Scale for the Assessment and Rating of Ataxia SARA Nine Hole Peg Test NHPT and Dexterity Questionnaire-24 DextQ-24 were used While Fatigue Severity Scale FSS and Fatigue Impact Scale FIS were used to examine general fatigue Beck Depression Inventory BDI was used to assess emotional status The mean age of healthy individuals with RRMS was 4008 981 years and the EDSS means of individuals with RRMS was 323 147 21 of both groups were female and 2 were male It was determined that the difference between MS individuals and healthy individuals SARA NHPT FSS and FIS averages initial and final strength values was statistically significant p005 and the decrease in force in individuals with RRMS was higher than in healthy individuals However there was no difference between RRMS and healthy individuals in terms of fatigability levels examined with the Dynamic and Static Fatigue Index p005 While the relationship of Static and Dynamic Fatigue Index with FSS and FIS was not statistically significant the relationship was significant with DextQ-24s dressing daily activities and TVCDDVD subsections p005 In individuals with early RRMS there is a decrease in the repetitive dynamic and continuous static contractions of the rough and pinch grip strength and this decrease is related to the negative impact on the daily living activities and functionality of the individuals In particular motor fatigue should be addressed from the early stages of rehabilitation programs that will be planned to maintain the active participation of individuals with RRMS in their daily living activities To show motor fatigue with indices further studies with different fatigue indices and individuals with RRMS at different EDSS levels are needed
Detailed Description:
Introduction Multiple sclerosis MS is the most common neurological disease that causes disability in young adults It usually progresses with exacerbations and remissions and causes various problems by affecting the central nervous system in different localizations
Fatigue is one of the most common symptoms of MS and has the greatest impact on the patients quality of life Fatigability which is defined as motor and muscle fatigue during motor tasks is the exercise-induced decrease in the muscles ability to produce power or force during sustainable tasks In individuals with MS fatigability levels are higher than in healthy individuals as the nervous system cannot provide the necessary activation stimulus during maximum voluntary or continuous contractions From the early stages of the disease individuals with MS face problems such as decreased grip strength and difficulty in holding small objects which reduce dexterity and complicate daily living activities
When fatigue studies in MS are examined It was observed that the studies focused mostly on the lower extremity and walking and the studies on the upper extremity were also quite limited To the best of our knowledge our study is the first in its field to evaluate rough and pinching hand fatigability general fatigue and functionality levels in Relapsing-Remitting MS RRMS patients and compare them with age- and sex-matched healthy individuals
It is stated that the EDSS which we use to evaluate the disability levels of RRMS patients is not sensitive enough to evaluate functional parameters such as dexterity and cognition in MS Therefore other specific assessment methods such as the Ataxia Rating and Rating Scale SARA the Nine-Hole Peg Test NHPT and the Skill Questionnaire-24 DextQ-24 were used to determine the level of functioning SARA is an internationally accepted scale that is frequently used in the evaluation of ataxia NHPT is the gold standard of performance-based assessment which detects the patients progress over time and is sensitive to changes in treatment DextQ-24 which was developed to measure manual dexterity and consists of 24 questions is divided into five subgroups washingcare dressing food and kitchen daily activities TVCDDVD The lowest total score is 24 and the highest is 96 An increase in the score means a decrease in dexterity Beck Depression Inventory BDI is a valid and reliable depression scale for neurological diseases
The Fatigue Severity Scale FSS was used to determine the severity of the fatigue levels of individuals during the day and the Fatigue Impact Scale FIS was used to determine the effects of fatigue on activities of daily living The Turkish validity and reliability study of both scales was conducted by Armutlu et al Static and dynamic fatigue levels in the coarse and pinch grip were assessed with a Jamar digital hand dynamometer and pinch meter respectively in the standard measuring position recommended by the American Association of Hand Therapists For the Dynamic Fatigue Index a maximum of 15 voluntary contractions were requested from the participant No rest was given between contractions and the number of remaining contractions was reported to the participant The highest value of the first 3 contractions MVC1 and the highest value of the last 3 contractions MVC2 were recorded and the dynamic fatigue index was calculated with the formula 1001-MVC2MVC1 For the Static Fatigue Index after a one-minute rest break the participant was asked to maintain the maximum voluntary contraction for 30 seconds and the participant was not informed about the remaining time Assuming that the participant can sustain the maximum voluntary contraction for 30 seconds taking into account the area generated in the graph Hypothetical Area Under the Force Curve HAUC and the area calculated by the time the participant can walk Actual Area Under the Power Curve AUC Static Fatigue Index 1001- AUCHAUC formula
The multi-dimensional evaluation of MS which threatens all aspects of life and causes limitations in daily living activities from the early period has an important place in the treatment and rehabilitation of individuals with MS Determination of hand fatigability is essential to understand the decrease in performance in daily life in individuals with MS and to understand its reflection on upper extremity functionality and to plan targeted rehabilitation Our study draws attention to the fact that hand fatigability may increase in activities that require repetitive and continuous contraction in individuals with RRMS from the early period and its relationship with upper extremity functionality For a clearer distinction of fatigability studies with different and more objective assessments of fatigue index and more studies with different types and different EDSS levels in individuals with RRMS are needed
Fatigue is one of the most common symptoms of MS and has the greatest impact on the patients quality of life Fatigability which is defined as motor and muscle fatigue during motor tasks is the exercise-induced decrease in the muscles ability to produce power or force during sustainable tasks In individuals with MS fatigability levels are higher than in healthy individuals as the nervous system cannot provide the necessary activation stimulus during maximum voluntary or continuous contractions From the early stages of the disease individuals with MS face problems such as decreased grip strength and difficulty in holding small objects which reduce dexterity and complicate daily living activities
When fatigue studies in MS are examined It was observed that the studies focused mostly on the lower extremity and walking and the studies on the upper extremity were also quite limited To the best of our knowledge our study is the first in its field to evaluate rough and pinching hand fatigability general fatigue and functionality levels in Relapsing-Remitting MS RRMS patients and compare them with age- and sex-matched healthy individuals
It is stated that the EDSS which we use to evaluate the disability levels of RRMS patients is not sensitive enough to evaluate functional parameters such as dexterity and cognition in MS Therefore other specific assessment methods such as the Ataxia Rating and Rating Scale SARA the Nine-Hole Peg Test NHPT and the Skill Questionnaire-24 DextQ-24 were used to determine the level of functioning SARA is an internationally accepted scale that is frequently used in the evaluation of ataxia NHPT is the gold standard of performance-based assessment which detects the patients progress over time and is sensitive to changes in treatment DextQ-24 which was developed to measure manual dexterity and consists of 24 questions is divided into five subgroups washingcare dressing food and kitchen daily activities TVCDDVD The lowest total score is 24 and the highest is 96 An increase in the score means a decrease in dexterity Beck Depression Inventory BDI is a valid and reliable depression scale for neurological diseases
The Fatigue Severity Scale FSS was used to determine the severity of the fatigue levels of individuals during the day and the Fatigue Impact Scale FIS was used to determine the effects of fatigue on activities of daily living The Turkish validity and reliability study of both scales was conducted by Armutlu et al Static and dynamic fatigue levels in the coarse and pinch grip were assessed with a Jamar digital hand dynamometer and pinch meter respectively in the standard measuring position recommended by the American Association of Hand Therapists For the Dynamic Fatigue Index a maximum of 15 voluntary contractions were requested from the participant No rest was given between contractions and the number of remaining contractions was reported to the participant The highest value of the first 3 contractions MVC1 and the highest value of the last 3 contractions MVC2 were recorded and the dynamic fatigue index was calculated with the formula 1001-MVC2MVC1 For the Static Fatigue Index after a one-minute rest break the participant was asked to maintain the maximum voluntary contraction for 30 seconds and the participant was not informed about the remaining time Assuming that the participant can sustain the maximum voluntary contraction for 30 seconds taking into account the area generated in the graph Hypothetical Area Under the Force Curve HAUC and the area calculated by the time the participant can walk Actual Area Under the Power Curve AUC Static Fatigue Index 1001- AUCHAUC formula
The multi-dimensional evaluation of MS which threatens all aspects of life and causes limitations in daily living activities from the early period has an important place in the treatment and rehabilitation of individuals with MS Determination of hand fatigability is essential to understand the decrease in performance in daily life in individuals with MS and to understand its reflection on upper extremity functionality and to plan targeted rehabilitation Our study draws attention to the fact that hand fatigability may increase in activities that require repetitive and continuous contraction in individuals with RRMS from the early period and its relationship with upper extremity functionality For a clearer distinction of fatigability studies with different and more objective assessments of fatigue index and more studies with different types and different EDSS levels in individuals with RRMS are needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None