NCT06704464

Brief Summary

Many assessment tools have been developed and used to evaluate upper extremity functions in multiple sclerosis (MS) patients. While each test has its strengths and weaknesses, the most significant limitation of these tests is that only a limited number assess both hands simultaneously. On the other hand, most daily life activities require the coordinated use of both hands. In MS patients, bilateral impairments in hand functions can also be observed. Therefore, there is a need for bilateral assessment tools. Unlike many other assessment tools, the Minnesota Manual Dexterity Test (MMDT) allows for simultaneous evaluation of both hands. In addition to manual dexterity, it also assesses hand-eye coordination and gross motor skills. The MMDT consists of five subtests: placing, turning, displacing, single-hand turning and placing, and two-hand turning and placing. The validity of the MMDT has also been examined in MS patients. Our study aims to evaluate the reliability and validity of the MMDT in MS patients. The cutoff times that best distinguish individuals with MS from healthy individuals will also be examined. The study aims to systematically and thoroughly evaluate the MMDT, establish it as a valid and reliable method for MS patients, and provide a new perspective on assessing hand functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

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

November 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

November 28, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

November 18, 2024

Last Update Submit

March 17, 2025

Conditions

Keywords

Minnesota manual dexterityreliabilityvaliditymultiple sclerosishand function

Outcome Measures

Primary Outcomes (2)

  • Minnesota Manual Dexterity Test

    The Minnesota Manual Dexterity Test (MMDT) is a performance test designed to evaluate hand functions and hand-eye coordination both unilaterally and bilaterally, higher scores mean a worse outcome.

    baseline (on the predetermined assessment day)

  • Minnesota Manual Dexterity Test-second

    The Minnesota Manual Dexterity Test (MMDT) is a performance test designed to evaluate hand functions and hand-eye coordination both unilaterally and bilaterally, higher scores mean a worse outcome.

    the second assessment will be conducted after the seven days

Secondary Outcomes (4)

  • 9-Hole Peg Test

    baseline (on the predetermined assessment day)

  • ABILHAND

    baseline (on the predetermined assessment day)

  • The Jebsen Hand Function Test

    baseline (on the predetermined assessment day)

  • The Expanded Disability Status Scale

    baseline (on the predetermined assessment day)

Study Arms (2)

Test Group

Patients with Multiple Sclerosis

Other: Manual DexterityOther: disability level

Control Group

healthy controls

Other: Manual Dexterity (only MMDT)

Interventions

Individuals who meet the inclusion criteria will be evaluated for manual dexterity using MMDT, 9-HPT, ABILHAND, and JTHFT.

Test Group

Individuals who meet the inclusion criteria will be evaluated for manual dexterity using MMDT on a predetermined day.

Control Group

Individuals who meet the inclusion criteria will be evaluated for disability level using EDSS

Test Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Multiple Sclerosis who apply to Sivas Cumhuriyet University, Department of Physiotherapy and Rehabilitation will be invited to this study.

You may qualify if:

  • Age at least 18 years,
  • Neurologist-diagnosed Multiple Sclerosis,
  • Expanded Disability Status Scale (EDSS) score between 0-6.5
  • No MS exacerbation within the last 3 months,
  • Use of stable medication in the last 3 months.

You may not qualify if:

  • Having any vision, hearing or perception problems that may affect the research results,
  • Having an orthopedic problem that may affect manual skills in the upper extremity,
  • Having a cardiovascular, pulmonary disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet Üniversity

Sivas, Turkey (Türkiye)

Location

Related Publications (2)

  • Celik RGG. Upper Extremity Capability Tests in Multiple Sclerosis. Noro Psikiyatr Ars. 2018;55(Suppl 1):S54-S57. doi: 10.29399/npa.23338.

  • Hervault M, Balto JM, Hubbard EA, Motl RW. Reliability, precision, and clinically important change of the Nine-Hole Peg Test in individuals with multiple sclerosis. Int J Rehabil Res. 2017 Mar;40(1):91-93. doi: 10.1097/MRR.0000000000000209.

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
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 26, 2024

Study Start

November 28, 2024

Primary Completion

January 25, 2025

Study Completion

January 25, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations