- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06704464
Investigation of Validity and Reliability of the Minnesota Manual Dexterity Test in Patients With Multiple Sclerosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sivas, Turkey
- Sivas Cumhuriyet University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Test Group
Patients with Multiple Sclerosis
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Individuals who meet the inclusion criteria will be evaluated for manual dexterity using MMDT, 9-HPT, ABILHAND, and JTHFT.
Individuals who meet the inclusion criteria will be evaluated for disability level using EDSS
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Control Group
healthy controls
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Individuals who meet the inclusion criteria will be evaluated for manual dexterity using MMDT on a predetermined day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Minnesota Manual Dexterity Test
Time Frame: baseline (on the predetermined assessment day)
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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.
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baseline (on the predetermined assessment day)
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Minnesota Manual Dexterity Test-second
Time Frame: the second assessment will be conducted after the seven days
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ABILHAND
Time Frame: baseline (on the predetermined assessment day)
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to assess for performance of activity.
score range 0-46 point, higher scores mean a better outcome.
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baseline (on the predetermined assessment day)
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9-Hole Peg Test
Time Frame: baseline (on the predetermined assessment day)
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The 9-Hole Peg Test (9-HPT) evaluates hand dexterity based on performance, higher scores mean a worse outcome.
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baseline (on the predetermined assessment day)
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The Jebsen Hand Function Test
Time Frame: baseline (on the predetermined assessment day)
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The Jebsen Hand Function Test (JHFT) is one of the objective and standardized tests that assesses fine motor skills and functional hand use by simulating daily living activities, higher scores mean a worse outcome.
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baseline (on the predetermined assessment day)
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The Expanded Disability Status Scale
Time Frame: baseline (on the predetermined assessment day)
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The Expanded Disability Status Scale (EDSS) is a scale used to determine the degree of disability resulting from multiple sclerosis (MS).
It evaluates eight functional domains: pyramidal, cerebellar, brainstem, sensory, bowel/bladder, visual, mental, and other functions.Score range 0-10, higher scores mean a worse outcome.
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baseline (on the predetermined assessment day)
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-MS-minnesota-reliability
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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