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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06270342
Other study ID # DTMS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 15, 2023

Study information

Verified date February 2024
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 15, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
dual task assessment
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.

Locations

Country Name City State
Turkey Kutahya Health Sciences University Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
30 minutes
Primary 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.
10 minutes
Primary 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. 10 minutes
Primary 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. 10 minutes
Primary 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). 15 minutes
Primary 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. 10 minutes
Primary 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. 5 minutes
Primary 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). 15 minutes
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