The Effect of Multiple-Task Training in Patients With Multiple Sclerosis

July 29, 2019 updated by: Cagla Ozkul, Gazi University

The Effect of Multiple-Task Training on Physical and Cognitive Functions in Patients With Multiple Sclerosis

The Activities of Daily Living requires the ability to perform multiple activities at the same time, not just the motor or cognitive activity. When many tasks are performed at the same time, the attention capacity is effectively used and attention is shared according to the difficulty and priority of the tasks. There is evidence that patients with Multiple Sclerosis (MS) have reduced performance during multitasking.

In this study, the investigators aim to investigate the effect of multitasking training on balance, mobility, upper extremity performance and cognitive functions in patients with MS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with MS between 0-1,5 score according to the Extended Disability Status Scale (EDSS) will be included in the study. The balance, mobility, upper extremity performance, the cognitive function will be evaluated twice.

The study was designed as a prospective, randomized controlled study. The patients will be randomly assigned to three groups, the "multi-task training (MT)" group, the "single task training (ST)" group, and "control" group. The training will be twice a week for 6 weeks.

Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the Wilcoxon Test. The significance level was set at p< 0.05

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

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

  • Turkey
      • Ankara, Turkey
        • Gazi University

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants who are ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses in the last 3 month, with an EDSS between 0-1,5.

Exclusion Criteria:

  • Participants who have orthopedic, vision, hearing, or perception problems

    • Patients who have any cardiovascular or pulmonary disease in which exercise is contraindicated

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single task training
The exercise program consisting of 10 different motor tasks will be implemented in a single task training group.
Other: Single task training
An exercise program consisting of 10 different motor tasks will be implemented in a single task training group.
Experimental: Multi-task training
In the multitasking training group, a second motor task in the first two weeks, a cognitive task in the third and fourth week, both motor and cognitive tasks in the last two weeks will be added to these 10 different motor tasks.
Other: Multi-task training
In the multitasking training group, a second motor task in the first two weeks, a cognitive task in the third and fourth week, both motor and cognitive tasks in the last two weeks will be added to these 10 different motor tasks.
No Intervention: Control group
The control group will be taught relaxation exercises and will be asked to perform the exercises at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function
Time Frame: thirty minutes
The Brief Repeatable Battery of Neuropsychological Tests
thirty minutes
Mobility
Time Frame: ten minutes]
Timed Up and Go Test
ten minutes]
Modified Sensory Organization Test
Time Frame: Fifteen minutes]
The Modified Sensory Organization Test, which is performed using computerized posturography, measures postural sway in response to 4 different sensory conditions is measured using a force platform.
Fifteen minutes]
Upper extremity function
Time Frame: ten minutes
9-Hole Peg Test
ten minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Severity
Time Frame: Five minutes
In the Fatigue Severity Scale (FSS), participants are asked to rate their fatigue level between 1 and 7 in the 9 statements (including motivation, exercise, physical functioning, carrying out duties, and interfering with work, family, or social life) during the last week.
Five minutes
Balance Confidence
Time Frame: five minutes
Activities-specific Balance Confidence (ABC) is a scale in which the patient rates his perceived level of confidence while performing 16 daily living activities.
five minutes
Physical Activity
Time Frame: ten minutes
International Physical Activity Questionnaire- Long version
ten minutes
Fatigue Impact
Time Frame: five minutes
Fatigue impact scale consists of forty questions and evaluates the effects of fatigue on the 3 dimensions of daily life activities; cognitive function, physical function and psychosocial function. Each question is graded between 0 (no problem) and 4 (maximum problem).
five minutes
Neuropsychological Questionnaire
Time Frame: one minute
Multiple Sclerosis Neuropsychological Questionnaire - MSNQ
one minute

Collaborators and Investigators

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

Sponsor

Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 18, 2018

Primary Completion (Actual)

July 4, 2019

Study Completion (Actual)

July 25, 2019

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (Actual)

May 1, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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