The Effect of the Level of Hand Fatigability on Multiple Sclerosis on General Fatigue and Functionality

NCT05880745 | Completed

• 1 other identifier: PamukkaleU-sımsek-MS-Tez-002
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Fatigue; Functionality; Multiple Sclerosis; Dexterity

Keywords

multiple sclerosis; fatigue; hand fatigability; manuel dexterity

Outcome Measures

Primary Outcomes (2)

• Expanded Disability Status Scale (EDSS)

  determination of everyone's disease severity- high score( high disability)

  1year

• Modified Ashworth Scale (MAS)

  spacticity level range 0-5(high score increased spacticity

  1 year

Secondary Outcomes (5)

• Ataxia Rating and Rating Scale (SARA)

  1 year

• Nine-Hole Peg Test (NHPT), and the Dexterity Questionnaire-24 (DextQ-24)

  1 year

• Beck Depression Scale

  1 year

• Fatigue Severity Scale (FSS) and Fatigue Impact Scale (FIS)

  1 year

• Dynamic and Static Fatigue Index

  1 year

Study Arms (2)

patient group

EXPERIMENTAL

Patients with MS

Diagnostic Test: Nine-Hole Peg Test (NHPT)

healthy group

EXPERIMENTAL

age-gender matched healthy persons

Diagnostic Test: Nine-Hole Peg Test (NHPT)

Interventions

Nine-Hole Peg Test (NHPT) DIAGNOSTIC_TEST

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

Also known as: Ataxia Rating and Rating Scale (SARA), Dexterity Questionnaire-24 (DextQ-24), Beck Depression Inventory (BDI), The Fatigue Severity Scale (FSS), Fatigue Impact Scale (FIS), Static and dynamic fatigue levels

healthy group; patient group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Using antidepressants. Refusal to participate in the study

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale Unıversity

Denizli, 20000, Turkey (Türkiye)

Location

Related Publications (1)

• Simsek D, Cetisli-Korkmaz N, Bir LS. Hand fatigability, self-reported fatigue, and functionality in individuals with multiple sclerosis: A cross-sectional study. Mult Scler Relat Disord. 2024 Nov;91:105863. doi: 10.1016/j.msard.2024.105863. Epub 2024 Sep 1.

  PMID: 39245025 DERIVED

MeSH Terms

Conditions

Fatigue; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• DUDU ŞIMŞEK, PhD student

  Pamukkale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Physiotherapist, PhD Student,Principal Investigator

Model Details: age-gender matched patient and healthy groups

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 30, 2023
• Study Start: December 8, 2018
• Primary Completion: June 10, 2019
• Study Completion: December 9, 2019
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)