Investigation of Hand Functions and Related Parameters in People With Multiple Sclerosis

June 22, 2021 updated by: Uğur OVACIK

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • MS diagnosis according to McDonald criteria
  • Relapsing Remitting MS clinical course type
  • 18-65 age range
  • Being able to understand and read Turkish

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Multiple Sclerosis
Individuals with early-stage multiple sclerosis
Healthy Volunteers
Healthy volunteers of similar age and sex as individuals with multiple sclerosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline (on the predetermined assessment day)
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.
baseline (on the predetermined assessment day)
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.
baseline (on the predetermined assessment day)
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.
baseline (on the predetermined assessment day)
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.
baseline (on the predetermined assessment day)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hand Held Dynamometer
Time Frame: baseline (on the predetermined assessment day)
To assess upper extremity muscle strength. Higher scores indicate better muscle strength.
baseline (on the predetermined assessment day)
Hand Dynamometer
Time Frame: baseline (on the predetermined assessment day)
To assess grip strength. Higher scores indicate better muscle strength.
baseline (on the predetermined assessment day)
Pinchmeter
Time Frame: baseline (on the predetermined assessment day)
To assess pinch strength. Higher scores indicate better muscle strength.
baseline (on the predetermined assessment day)
Tuning fork
Time Frame: baseline (on the predetermined assessment day)
To assess deep sense. A higher score indicates better sensitivity.
baseline (on the predetermined assessment day)
Aesthesiometer
Time Frame: baseline (on the predetermined assessment day)
To assess two-point discrimination. A higher score indicates worse sensitivity.
baseline (on the predetermined assessment day)
Fatigue Severity Scale
Time Frame: baseline (on the predetermined assessment day)
To assess the severity of fatigue. Score range 1-7 point, a higher score indicates more severe fatigue.
baseline (on the predetermined assessment day)
Symbol Digit Modalities Test
Time Frame: baseline (on the predetermined assessment day)
To assess cognitive level. A higher score indicates better cognitive level.
baseline (on the predetermined assessment day)
Hospital Anxiety and Depression Scale
Time Frame: baseline (on the predetermined assessment day)
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.
baseline (on the predetermined assessment day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uğur OVACIK

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • İAÜ2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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