NCT06270342

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

February 12, 2024

Last Update Submit

February 20, 2024

Conditions

Keywords

Dual TaskDual Task EffectMultiple SclerosisUpper Extremity

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

MS

patients with multiple sclerosis

Other: dual task assessment

Control

healthy volunteers

Other: dual task assessment

Interventions

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.

ControlMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having been diagnosed with MS and healthy volunteers

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 21, 2024

Study Start

June 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 15, 2023

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations