- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05880745
The Effect of the Level of Hand Fatigability on Multiple Sclerosis on General Fatigue and Functionality
The Effect of the Level of Hand Fatigability on Multiple Sclerosis on General Fatigue and Functionality: A Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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 patient's quality of life . Fatigability, which is defined as motor and muscle fatigue during motor tasks, is the exercise-induced decrease in the muscle's 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 patient's 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 washing/care, dressing, food and kitchen, daily activities, TV/CD/DVD. 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 100*[1-(MVC2/MVC1)]. 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 100*[1- (AUC/HAUC)] 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Denizli, Turkey, 20000
- Pamukkale Unıversity
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient Group Being diagnosed with Relapsing Remitting Multiple Sclerosis. Being between the ages of 18-60. Agree to participate in the study. Not having an attack in the last 1 month. Expanded Disability Status Scale (GEDS) score between 1-5.5. Spasticity level in the wrist and finger flexors is between 0 and 1+ according to the Modified Ashworth Scale.
Not having any other neurological or orthopedic or rheumatological disease affecting the upper extremity.
Healthy Adult Group Agree to participate in the study. Being between the ages of 18-60. Not having a neurological disease or an orthopedic or rheumatological disease affecting the upper extremity.
Having similar demographic characteristics with the patient group participating in the study.
Exclusion Criteria:
- Using antidepressants. Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patient group
Patients with MS
|
Ataxia Rating and Rating Scale (SARA) for coordination Nine-Hole Peg Test (NHPT) and Dexterity Questionnaire-24 (DextQ-24) for manuel dexterity Beck Depression Inventory (BDI) for depression level The Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS) for general fatigue level Static and dynamic fatigue levels for hand fatigability
Other Names:
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Experimental: healthy group
age-gender matched healthy persons
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Ataxia Rating and Rating Scale (SARA) for coordination Nine-Hole Peg Test (NHPT) and Dexterity Questionnaire-24 (DextQ-24) for manuel dexterity Beck Depression Inventory (BDI) for depression level The Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS) for general fatigue level Static and dynamic fatigue levels for hand fatigability
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expanded Disability Status Scale (EDSS)
Time Frame: 1year
|
determination of everyone's disease severity- high score( high disability)
|
1year
|
Modified Ashworth Scale (MAS)
Time Frame: 1 year
|
spacticity level range 0-5(high score increased spacticity
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ataxia Rating and Rating Scale (SARA)
Time Frame: 1 year
|
ataxia level- per item 0-2 - high score high ataxia
|
1 year
|
Nine-Hole Peg Test (NHPT), and the Dexterity Questionnaire-24 (DextQ-24)
Time Frame: 1 year
|
manuel dexterity- min- max score 0-96- high score loss of dexterity
|
1 year
|
Beck Depression Scale
Time Frame: 1 year
|
depression level min-max 0-63- high score high depression level
|
1 year
|
Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS)
Time Frame: 1 year
|
general fatigue- min -max 7-63- high score high fatigue
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1 year
|
Dynamic and Static Fatigue Index
Time Frame: 1 year
|
hand fatigability assessment- high score high fatigability
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: DUDU ŞIMŞEK, PhD student, Pamukkale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PamukkaleU-sımsek-MS-Tez-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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