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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04721340
Other study ID # 2020/03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2021
Est. completion date May 16, 2021

Study information

Verified date June 2021
Source Istanbul Aydin University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to report the results of manual dexterity using the Minnesota Manual Dexterity Test in people with Multiple Sclerosis.


Description:

Upper limb can be affected even in early stage in people with Multiple Sclerosis (pwMS). Manual dexterity is important to maintain upper limb function and 9-Hole Peg Test (9HPT) is used as gold standard to assess dexterity in pwMS. There are no studies evaluating manual dexterity with the Minnesota Manual Dexterity Test (MMDT) in pwMS. This study aims to: 1. reporting the results of manual dexterity using the Minnesota Manual Dexterity Test and comparing the test results with healthy volunteers, 2. examining the relationship between MMDT and 9HPT, ABILHAND, grip strength, pinch strength, fatigue.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 16, 2021
Est. primary completion date May 2, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - (1) age 18-65; - (2) definitive diagnosis of MS according to McDonald criteria; - (3) ability to read and write in Turkish. Exclusion Criteria: - (1) acute attacks of MS (within 3 months); - (2) cognitive impairment (Mini Mental test result 24 points and below); - (3) having spasticity (3 and above according to Modified Ashworth Scale) - (4) any chronic disease other than MS; - (5) being addicted to alcohol or drugs,

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Test Group
Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.
Control Grup
Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.

Locations

Country Name City State
Turkey Istanbul Aydin University Istanbul Küçükçekmece

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Aydin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minnesota Manual Dexterity Test to assess manual dexterity, higher scores mean a worse outcome. baseline (on the predetermined assessment day)
Secondary 9-Hole Peg Test to assess manual dexterity. higher scores mean a worse outcome. baseline (on the predetermined assessment day)
Secondary ABILHAND to assess for performance of activity. score range 0-46 point, higher scores mean a better outcome. baseline (on the predetermined assessment day)
Secondary grip strength using hand dynamometer. higher scores mean a better outcome. baseline (on the predetermined assessment day)
Secondary pinch strength using pinchmeter. higher scores mean a better outcome. baseline (on the predetermined assessment day)
Secondary Fatigue Severity Scale to assess fatigue. score range 0-7 point, higher scores mean a worse outcome. baseline (on the predetermined assessment day)
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