- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06270342
The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients
February 20, 2024 updated by: Eda Ozge OKUR, Kutahya Health Sciences University
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kütahya, Turkey, 43100
- Kutahya Health Sciences University
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients having been diagnosed with MS and healthy volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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 |
Intervention / Treatment |
---|---|
Control
healthy volunteers
|
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.
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MS
patients with multiple sclerosis
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Minnesota Manual Dexterity Test
Time Frame: 30 minutes
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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. |
30 minutes
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Dual Task Questionnaire
Time Frame: 10 minutes
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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. |
10 minutes
|
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.
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10 minutes
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Expanded Disability Status Scale
Time Frame: 10 minutes
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Disability Status Evaluation.
A score of 0 on the scale indicates normal neurological status, while a score of 10 means MS-related death.
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10 minutes
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Brief International Cognitive Assessment Battery for Multiple Sclerosis
Time Frame: 15 minutes
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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).
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15 minutes
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Beck Depression Scale
Time Frame: 10 minutes
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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.
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10 minutes
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Fatigue Impact Scale
Time Frame: 5 minutes
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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.
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5 minutes
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Multiple Sclerosis Quality of Life Questionnaire-54
Time Frame: 15 minutes
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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).
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15 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
June 1, 2023
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
December 15, 2023
Study Registration Dates
First Submitted
February 12, 2024
First Submitted That Met QC Criteria
February 20, 2024
First Posted (Estimated)
February 21, 2024
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DTMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is not a plan to make IPD available.
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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