NCT04721340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

February 2, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

January 19, 2021

Last Update Submit

June 14, 2021

Conditions

Keywords

multiple sclerosisupper limbmanual dexterityassessmentminnesota manual dexterity test

Outcome Measures

Primary Outcomes (1)

  • Minnesota Manual Dexterity Test

    to assess manual dexterity, higher scores mean a worse outcome.

    baseline (on the predetermined assessment day)

Secondary Outcomes (5)

  • 9-Hole Peg Test

    baseline (on the predetermined assessment day)

  • ABILHAND

    baseline (on the predetermined assessment day)

  • grip strength

    baseline (on the predetermined assessment day)

  • pinch strength

    baseline (on the predetermined assessment day)

  • Fatigue Severity Scale

    baseline (on the predetermined assessment day)

Study Arms (2)

Test Group

people with multiple sclerosis

Other: Test Group

Control Group

healthy volunteers

Other: Control Grup

Interventions

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

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 Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • (1) age 18-65;
  • (2) definitive diagnosis of MS according to McDonald criteria;
  • (3) ability to read and write in Turkish.

You may not qualify if:

  • (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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University

Istanbul, Küçükçekmece, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in physiotherapy and principal investigator of the study

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

February 2, 2021

Primary Completion

May 2, 2021

Study Completion

May 16, 2021

Last Updated

June 15, 2021

Record last verified: 2021-06

Locations