The Minnesota Manual Dexterity Test As A Measure Of Hand... | NCT04721340

Studies
The Minnesota Manual Dexterity Test As A Measure Of Hand Function in Multiple Sclerosis

NCT04721340

Sponsor

Istanbul Aydın University

Status

Completed

Last Update Posted

Jun 15, 2021Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Test Group
Control Grup

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2021Actual

Primary Completion Date

May 2, 2021Actual

Completion Date

May 16, 2021Actual

First Submitted Date

Jan 19, 2021

First Submission Date that Met QC Criteria

Jan 21, 2021

First Posted Date

Jan 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2021

Last Update Posted Date

Jun 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Uğur OVACIK, Lecturer in physiotherapy and principal investigator of the study, Istanbul Aydın UniversityPrincipal Investigator

Lead Sponsor

Istanbul Aydın UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Group		people with multiple sclerosis	Other: Test Group
Control Group		healthy volunteers	Other: Control Grup

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Test Group	Other	Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Minnesota Manual Dexterity Test	to assess manual dexterity, higher scores mean a worse outcome.	baseline (on the predetermined assessment day)

Secondary Outcomes

Measure	Description	Time Frame
9-Hole Peg Test	to assess manual dexterity. higher scores mean a worse outcome.	baseline (on the predetermined assessment day)
ABILHAND	to assess for performance of activity. score range 0-46 point, higher scores mean a better outcome.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Aydin University		Istanbul	Küçükçekmece		Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

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Browse Branches

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