Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05880745 |
| Other study ID # |
PamukkaleU-simsek-MS-Tez-002 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 8, 2018 |
| Est. completion date |
December 9, 2019 |
Study information
| Verified date |
May 2023 |
| Source |
Pamukkale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 40.08, 21 females, mean time since diagnosis 9.43 years, mean Expanded Disability Status
Scale 3.23) 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
40.08 ± 9.81 years, and the EDSS means of individuals with RRMS was 3.23 ± 1.47. 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 (p≤0.05), 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 (p>0.05). While the relationship of Static and Dynamic
Fatigue Index with FSS and FIS was not statistically significant, the relationship was
significant with DextQ-24's dressing, daily activities and TV/CD/DVD subsections (p<0.05). 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.
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.
