Multiple SclerosisNCT04933110
Investigation of Hand Functions and Related Parameters in People With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Uğur OVACIK.
Trial summary
The upper extremity in people with Multiple Sclerosis (pwMS) has become a more popular research topic in recent years, with the increase in studies reporting widespread involvement. 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
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2021to 20 Sep 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: Individuals with MS who met the inclusion criteria and volunteered to participate in the study. Volunteer healthy individuals of similar age and sex with individuals with MS.
Who may be able to join
- MS diagnosis according to McDonald criteria
- Relapsing Remitting MS clinical course type
- 18-65 age range
- Being able to understand and read Turkish
Who cannot join
- Having an MS attack in the last 3 months
- To have done regular exercise for the upper extremity in the 6 months before starting the study
- Having different neurological, orthopedic or cardiac problems other than MS
- Being addicted to alcohol or drugs
- Getting a score below 24 on the Mini Mental Test Scale
- Having a spasticity of 3 or more according to the Modified Ashworth Scale
About this study
Official title: Investigation of Hand Functions and Related Parameters in People With Multiple Sclerosis in the Very Early Stage.
The upper extremity in people with Multiple Sclerosis (pwMS) has become a more popular research topic in recent years, with the increase in studies reporting widespread involvement. The aim of our study was to evaluate the upper extremity from multiple perspectives in early stage pwMS, to identify problems by comparing them with healthy individuals, and to examine the relationship of problems with activity and participation.
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, upper limb function, activity, participation
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Individuals with early-stage multiple sclerosis | |
| Healthy Volunteers | Healthy volunteers of similar age and sex as individuals with multiple sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine Hole Peg Test
To assess upper extremity function. Completing the test in a short time (seconds) indicates better upper extremity function.
Measured: baseline (on the predetermined assessment day)
Minnesota Manual Dexterity Test
To assess upper extremity function. Completing the test in a short time (seconds) indicates better upper extremity function.
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)
Motor Activity Log-28
To assess for performance of activity. Score range 0-5 point, a high score indicates good upper extremity use frequency and quality of movement during activity.
Measured: baseline (on the predetermined assessment day)
Community Integration Questionnaire
To assess participation. The total score ranges from 0-29, and the higher the score, the higher the individual's participation in society is considered.
Measured: baseline (on the predetermined assessment day)
Secondary outcomes (8)
Hand Held Dynamometer
To assess upper extremity muscle strength. Higher scores indicate better muscle strength.
Measured: baseline (on the predetermined assessment day)
Hand Dynamometer
To assess grip strength. Higher scores indicate better muscle strength.
Measured: baseline (on the predetermined assessment day)
Pinchmeter
To assess pinch strength. Higher scores indicate better muscle strength.
Measured: baseline (on the predetermined assessment day)
Tuning fork
To assess deep sense. A higher score indicates better sensitivity.
Measured: baseline (on the predetermined assessment day)
Aesthesiometer
To assess two-point discrimination. A higher score indicates worse sensitivity.
Measured: baseline (on the predetermined assessment day)
Fatigue Severity Scale
To assess the severity of fatigue. Score range 1-7 point, a higher score indicates more severe fatigue.
Measured: baseline (on the predetermined assessment day)
Symbol Digit Modalities Test
To assess cognitive level. A higher score indicates better cognitive level.
Measured: baseline (on the predetermined assessment day)
Hospital Anxiety and Depression Scale
To assess anxiety and depression. The total score ranges from 0 to 21 for each of the two subscales. A higher score indicates more severe anxiety and depression.
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 posted21 Jun 2021
- Study start5 Jul 2021 (estimated)
- Primary completion6 Sep 2021 (estimated)
- Study completion20 Sep 2021 (estimated)
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-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uğur OVACIK
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor-investigator, Uğur OVACIK, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933110
- Sponsor's protocol ID
- İAÜ2
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 25 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 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Hand Functions and Related Parameters in People With Multiple Sclerosis in the Very Early Stage.
- ClinicalTrials.gov ID
- NCT04933110
- Acronym / sponsor ID
- İAÜ2
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, upper limb function, activity, participation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Uğur OVACIKUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 5 Jul 2021 (estimated)
- Primary completion
- 6 Sep 2021 (estimated)
- Study completion
- 20 Sep 2021 (estimated)
- First posted
- 21 Jun 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 upper extremity in people with Multiple Sclerosis (pwMS) has become a more popular research topic in recent years, with the increase in studies reporting widespread involvement. The aim of our study was to evaluate the upper extremity from multiple perspectives in early stage pwMS, to identify problems by comparing them with healthy individuals, and to examine the relationship of problems with activity and participation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | – | –Individuals with early-stage multiple sclerosis |
| Healthy Volunteers | – | –Healthy volunteers of similar age and sex as individuals with multiple sclerosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with MS who met the inclusion criteria and volunteered to participate in the study. Volunteer healthy individuals of similar age and sex with individuals with MS.
Key inclusion criteria (4 listed)
- MS diagnosis according to McDonald criteria
- Relapsing Remitting MS clinical course type
- 18-65 age range
- Being able to understand and read Turkish
Key exclusion criteria (6 listed)
- Having an MS attack in the last 3 months
- To have done regular exercise for the upper extremity in the 6 months before starting the study
- Having different neurological, orthopedic or cardiac problems other than MS
- Being addicted to alcohol or drugs
- Getting a score below 24 on the Mini Mental Test Scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nine Hole Peg Test
Time frame: baseline (on the predetermined assessment day)
To assess upper extremity function. Completing the test in a short time (seconds) indicates better upper extremity function.
Minnesota Manual Dexterity Test
Time frame: baseline (on the predetermined assessment day)
To assess upper extremity function. Completing the test in a short time (seconds) indicates better upper extremity function.
ABILHAND
Time frame: baseline (on the predetermined assessment day)
To assess for performance of activity. Score range 0-46 point, higher scores mean a better outcome.
Motor Activity Log-28
Time frame: baseline (on the predetermined assessment day)
To assess for performance of activity. Score range 0-5 point, a high score indicates good upper extremity use frequency and quality of movement during activity.
Community Integration Questionnaire
Time frame: baseline (on the predetermined assessment day)
To assess participation. The total score ranges from 0-29, and the higher the score, the higher the individual's participation in society is considered.
8 secondary outcomes
Hand Held Dynamometer
Time frame: baseline (on the predetermined assessment day)
Hand Dynamometer
Time frame: baseline (on the predetermined assessment day)
Pinchmeter
Time frame: baseline (on the predetermined assessment day)
Tuning fork
Time frame: baseline (on the predetermined assessment day)
Aesthesiometer
Time frame: baseline (on the predetermined assessment day)
Fatigue Severity Scale
Time frame: baseline (on the predetermined assessment day)
Symbol Digit Modalities Test
Time frame: baseline (on the predetermined assessment day)
Hospital Anxiety and Depression Scale
Time frame: baseline (on the predetermined assessment day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Uğur OVACIK.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Nine Hole Peg Test (time frame: baseline (on the predetermined assessment day)). The study lists 5 primary outcomes in all. 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 25 Jun 2021.