Multiple SclerosisNCT06270342
The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (MS) and compare with healthy controls. 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?
- dual task assessment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 15 Dec 2023
- 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: Patients having been diagnosed with MS and healthy volunteers
Who may be able to join
- Having been diagnosed with Multiple Sclerosis for at least 1 year
- Being between the ages of 18-65
- Being at least a primary school graduate
- Volunteering to participate in the study
- EDSS score between 1 and 6.5
Who cannot join
- Patients whose Multiple Sclerosis diagnosis is uncertain
- Having additional neurological disease that may affect clinical evaluation
- Having a neurological and/or psychiatric disease that may affect cognitive tests
- Having had an attack in the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
The primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (MS) and compare with healthy controls. Additionally, another aim of our study was to compare the cognitive status, quality of life, fatigue and emotional states of individuals with MS and healthy controls.
Read the detailed description
The study was carried out at Kutahya Health Sciences University Evliya Çelebi Training and Research Hospital. 30 individuals with MS and 30 healthy controls, aged 18-65, were included in the study. In the evaluation, demographic and clinical data were recorded first. The Minnesota Manual Dexterity Test was used to evaluate the upper extremity function of the participants in single and dual task conditions, and the Dual Task Questionnaire was used to evaluate the difficulties experienced during dual tasks.
- Conditions
- Multiple Sclerosis
- Being tested
- dual task assessment
- Keywords
- Dual Task, Dual Task Effect, Multiple Sclerosis, Upper Extremity
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual task assessmentOther
The Minnesota Manual Dexterity Test was used to evaluate the upper extremity function of the participants in single and dual task conditions, and the Dual Task Questionnaire was used to evaluate the difficulties experienced during dual tasks. In the dual-task turning test, in addition to the single-task turning test, they were given a cognitive task, the task of counting the months of the year backwards from December to January. The dual-task turning test was continued by changing hands at the end of each turn until the last disk was turned. Meanwhile, verbal fluency and hand errors made while spinning the disc were recorded.
| Study group | Role | What they receive |
|---|---|---|
| MS | patients with multiple sclerosis Receives: Other: dual task assessment | |
| Control | healthy volunteers Receives: Other: dual task assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Minnesota Manual Dexterity Test
Upper Extremity Function Evaluation. The Minnesota Manual Dexterity Test basically consists of two subtests, the placement and translation test.
Completing the test faster indicates better dexterity.
Measured: 30 minutes
Dual Task Questionnaire
Dual Task Difficulty Evaluation. The survey consists of 10 items and is scored out of 5 points per question.
A higher total score indicates worse dual task performance.
Measured: 10 minutes
Edinburgh Handedness Questionnaire
Hand Preference Evaluation. The total scoring is between 100 and -100, individuals with more than 40 points are given right hand; Individuals in this score range from 40 to -40 inclusive are recorded as those who use both hands actively, and individuals with scores of -40 points and below are recorded as left-handed.
Measured: 10 minutes
Expanded Disability Status Scale
Disability Status Evaluation. A score of 0 on the scale indicates normal neurological status, while a score of 10 means MS-related death.
Measured: 10 minutes
Brief International Cognitive Assessment Battery for Multiple Sclerosis
Cognitive Status Evaluation. BICAMS comprises three tests, the Symbol Digit Modalities Test (SDMT), the learning trials of the California Verbal Learning Test II (CVLT-II), and the Brief Visuospatial Memory Test-Revised (BVMT-R).
Measured: 15 minutes
Beck Depression Scale
Emotional Status Evaluation. The lowest score that can be obtained from the scale is 0 and the highest score is 63. According to the resulting total score; It results in absence-mild, mild-moderate, moderate-severe or severe.
Measured: 10 minutes
Fatigue Impact Scale
Fatigue Status Evaluation. Each question receives a score between 0 (no problem) and 4 (maximum problem). The highest score is 160, and higher scores indicate fatigue.
Measured: 5 minutes
Multiple Sclerosis Quality of Life Questionnaire-54
Quality of Life Status Evaluation. The survey contains 54 questions consisting of 12 sections. Added 18 questions are about; general quality of life (2 items), health stress (4 items), sexual functions and satisfaction (5 items), cognitive functions (4 items), energy (1 item), pain (1 item) and social functions (1 item).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Jun 2023
- Primary completion1 Sep 2023
- Study completion15 Dec 2023
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
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Ozge OKUR, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270342
- Sponsor's protocol ID
- DTMS
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06270342
- Acronym / sponsor ID
- DTMS
- Conditions
- Multiple Sclerosis
- Keywords
- Dual Task, Dual Task Effect, Multiple Sclerosis, Upper Extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 21 Feb 2024 (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 primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (MS) and compare with healthy controls. Additionally, another aim of our study was to compare the cognitive status, quality of life, fatigue and emotional states of individuals with MS and healthy controls.
Detailed description
The study was carried out at Kutahya Health Sciences University Evliya Çelebi Training and Research Hospital. 30 individuals with MS and 30 healthy controls, aged 18-65, were included in the study. In the evaluation, demographic and clinical data were recorded first. The Minnesota Manual Dexterity Test was used to evaluate the upper extremity function of the participants in single and dual task conditions, and the Dual Task Questionnaire was used to evaluate the difficulties experienced during dual tasks.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS | – | Other: dual task assessmentpatients with multiple sclerosis |
| Control | – | Other: dual task assessmenthealthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having been diagnosed with MS and healthy volunteers
Key inclusion criteria (5 listed)
- Having been diagnosed with Multiple Sclerosis for at least 1 year
- Being between the ages of 18-65
- Being at least a primary school graduate
- Volunteering to participate in the study
- EDSS score between 1 and 6.5
Key exclusion criteria (4 listed)
- Patients whose Multiple Sclerosis diagnosis is uncertain
- Having additional neurological disease that may affect clinical evaluation
- Having a neurological and/or psychiatric disease that may affect cognitive tests
- Having had an attack in the last 3 months
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 |
|---|---|---|
| dual task assessmentThe Minnesota Manual Dexterity Test was used to evaluate the upper extremity function of the participants in single and dual task conditions, and the Dual Task Questionnaire was used to evaluate the difficulties experienced during dual tasks. In the dual-task turning test, in addition to the single-task turning test, they were given a cognitive task, the task of counting the months of the year backwards from December to January. The dual-task turning test was continued by changing hands at the end of each turn until the last disk was turned. Meanwhile, verbal fluency and hand errors made while spinning the disc were recorded. | Other | Control, MS |
Primary outcome
The Minnesota Manual Dexterity Test
Time frame: 30 minutes
Upper Extremity Function Evaluation. The Minnesota Manual Dexterity Test basically consists of two subtests, the placement and translation test. Completing the test faster indicates better dexterity.
Dual Task Questionnaire
Time frame: 10 minutes
Dual Task Difficulty Evaluation. The survey consists of 10 items and is scored out of 5 points per question. A higher total score indicates worse dual task performance.
Edinburgh Handedness Questionnaire
Time frame: 10 minutes
Hand Preference Evaluation. The total scoring is between 100 and -100, individuals with more than 40 points are given right hand; Individuals in this score range from 40 to -40 inclusive are recorded as those who use both hands actively, and individuals with scores of -40 points and below are recorded as left-handed.
Expanded Disability Status Scale
Time frame: 10 minutes
Disability Status Evaluation. A score of 0 on the scale indicates normal neurological status, while a score of 10 means MS-related death.
Brief International Cognitive Assessment Battery for Multiple Sclerosis
Time frame: 15 minutes
Cognitive Status Evaluation. BICAMS comprises three tests, the Symbol Digit Modalities Test (SDMT), the learning trials of the California Verbal Learning Test II (CVLT-II), and the Brief Visuospatial Memory Test-Revised (BVMT-R).
Beck Depression Scale
Time frame: 10 minutes
Emotional Status Evaluation. The lowest score that can be obtained from the scale is 0 and the highest score is 63. According to the resulting total score; It results in absence-mild, mild-moderate, moderate-severe or severe.
Fatigue Impact Scale
Time frame: 5 minutes
Fatigue Status Evaluation. Each question receives a score between 0 (no problem) and 4 (maximum problem). The highest score is 160, and higher scores indicate fatigue.
Multiple Sclerosis Quality of Life Questionnaire-54
Time frame: 15 minutes
Quality of Life Status Evaluation. The survey contains 54 questions consisting of 12 sections. Added 18 questions are about; general quality of life (2 items), health stress (4 items), sexual functions and satisfaction (5 items), cognitive functions (4 items), energy (1 item), pain (1 item) and social functions (1 item).
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 21 Feb 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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 Kutahya Health Sciences 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 5 inclusion and 4 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 21 Feb 2024. 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?
The Minnesota Manual Dexterity Test (time frame: 30 minutes). The study lists 8 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 21 Feb 2024.