Multiple SclerosisNCT04721340
The Minnesota Manual Dexterity Test As A Measure Of Hand Function in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Test Group
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2021to 16 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- (1) age 18-65;
- (2) definitive diagnosis of MS according to McDonald criteria;
- (3) ability to read and write in Turkish.
Who cannot join
- (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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydin University
Istanbul, Küçükçekmece
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Test Group, Control Grup
- Keywords
- multiple sclerosis, upper limb, manual dexterity, assessment, minnesota manual dexterity test
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test GroupOther
Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.
Control GrupOther
Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | people with multiple sclerosis Receives: Other: Test Group | |
| Control Group | healthy volunteers Receives: Other: Control Grup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota Manual Dexterity Test
to assess manual dexterity, higher scores mean a worse outcome.
Measured: baseline (on the predetermined assessment day)
Secondary outcomes (5)
9-Hole Peg Test
to assess manual dexterity. higher scores mean a worse outcome.
Measured: baseline (on the predetermined assessment day)
ABILHAND
to assess for performance of activity. score range 0-46 point, higher scores mean a better outcome.
Measured: baseline (on the predetermined assessment day)
grip strength
using hand dynamometer. higher scores mean a better outcome.
Measured: baseline (on the predetermined assessment day)
pinch strength
using pinchmeter. higher scores mean a better outcome.
Measured: baseline (on the predetermined assessment day)
Fatigue Severity Scale
to assess fatigue. score range 0-7 point, higher scores mean a worse outcome.
Measured: baseline (on the predetermined assessment day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start2 Feb 2021
- Primary completion2 May 2021
- Study completion16 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uğur OVACIK, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721340
- Sponsor's protocol ID
- 2020/03
- Status last verified
- Jun 2021
- First submitted
- 19 Jan 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Assessment in Multiple Sclerosis: The Minnesota Manual Dexterity Test As A Measure Of Hand Function
- ClinicalTrials.gov ID
- NCT04721340
- Acronym / sponsor ID
- 2020/03
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, upper limb, manual dexterity, assessment, minnesota manual dexterity test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 16 May 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | Other: Test Grouppeople with multiple sclerosis |
| Control Group | – | Other: Control Gruphealthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- (1) age 18-65;
- (2) definitive diagnosis of MS according to McDonald criteria;
- (3) ability to read and write in Turkish.
Key exclusion criteria (5 listed)
- (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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test GroupIndividuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day. | Other | Test Group |
| Control GrupIndividuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day. | Other | Control Group |
Primary outcome
Minnesota Manual Dexterity Test
Time frame: baseline (on the predetermined assessment day)
to assess manual dexterity, higher scores mean a worse outcome.
5 secondary outcomes
9-Hole Peg Test
Time frame: baseline (on the predetermined assessment day)
ABILHAND
Time frame: baseline (on the predetermined assessment day)
grip strength
Time frame: baseline (on the predetermined assessment day)
pinch strength
Time frame: baseline (on the predetermined assessment day)
Fatigue Severity Scale
Time frame: baseline (on the predetermined assessment day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minnesota Manual Dexterity Test (time frame: baseline (on the predetermined assessment day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.