- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04721340
The Minnesota Manual Dexterity Test As A Measure Of Hand Function in Multiple Sclerosis
June 14, 2021 updated by: Uğur OVACIK, Istanbul Aydın University
Upper Limb Assessment in Multiple Sclerosis: The Minnesota Manual Dexterity Test As A Measure Of Hand Function
The aim of the study is to report the results of manual dexterity using the Minnesota Manual Dexterity Test in people with Multiple Sclerosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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:
- reporting the results of manual dexterity using the Minnesota Manual Dexterity Test and comparing the test results with healthy volunteers,
- examining the relationship between MMDT and 9HPT, ABILHAND, grip strength, pinch strength, fatigue.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Küçükçekmece
-
Istanbul, Küçükçekmece, Turkey
- Istanbul Aydin University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Test group: 80 people with multiple sclerosis will be evaluated.
Inclusion and exlusion criteria listed above.
Control group: 40 healthy volunteers with demographic characteristics similar to people with multiple sclerosis will be evaluated to compare people with multiple sclerosis.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Test Group
people with multiple sclerosis
|
Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.
|
Control Group
healthy volunteers
|
Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minnesota Manual Dexterity Test
Time Frame: baseline (on the predetermined assessment day)
|
to assess manual dexterity, higher scores mean a worse outcome.
|
baseline (on the predetermined assessment day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
9-Hole Peg Test
Time Frame: baseline (on the predetermined assessment day)
|
to assess manual dexterity.
higher scores mean a worse outcome.
|
baseline (on the predetermined assessment day)
|
ABILHAND
Time Frame: baseline (on the predetermined assessment day)
|
to assess for performance of activity.
score range 0-46 point, higher scores mean a better outcome.
|
baseline (on the predetermined assessment day)
|
grip strength
Time Frame: baseline (on the predetermined assessment day)
|
using hand dynamometer.
higher scores mean a better outcome.
|
baseline (on the predetermined assessment day)
|
pinch strength
Time Frame: baseline (on the predetermined assessment day)
|
using pinchmeter.
higher scores mean a better outcome.
|
baseline (on the predetermined assessment day)
|
Fatigue Severity Scale
Time Frame: baseline (on the predetermined assessment day)
|
to assess fatigue.
score range 0-7 point, higher scores mean a worse outcome.
|
baseline (on the predetermined assessment day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2021
Primary Completion (Actual)
May 2, 2021
Study Completion (Actual)
May 16, 2021
Study Registration Dates
First Submitted
January 19, 2021
First Submitted That Met QC Criteria
January 21, 2021
First Posted (Actual)
January 22, 2021
Study Record Updates
Last Update Posted (Actual)
June 15, 2021
Last Update Submitted That Met QC Criteria
June 14, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Brigham and Women's HospitalMassachusetts General HospitalRecruitingMultiple Sclerosis | Relapsing Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
University of MinnesotaMallinckrodtTerminatedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
Clinical Trials on Test Group
-
Cairo UniversityUnknown
-
Universitat Internacional de CatalunyaBotiss Medical AG; Klockner Implant System S.A.RecruitingDental Implant | Bone Regeneration | Narrow ImplantSpain
-
AstraZenecaCompletedChronic Obstructive Pulmonary DiseaseUnited Kingdom
-
University Hospital, BordeauxTerminated
-
Universidade Federal FluminenseCompletedTooth Extraction Status NosBrazil
-
Gonabad University of Medical SciencesCompletedHealth Behavior | Social BehaviorIran, Islamic Republic of
-
Groupe Hospitalier Paris Saint JosephRecruiting
-
Shehla GulCompleted
-
University GhentInstitut de Recherche en Sciences de la Sante, Burkina Faso; Addis Ababa University and other collaboratorsRecruiting
-
Universidad Complutense de MadridActive, not recruiting