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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Multi-task training
Single task training
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Multi-task training, Balance, Mobility, Cognition, Upper extremity function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Single task training

Multi-task training

Control group

Arm Description

The exercise program consisting of 10 different motor tasks will be implemented in a single task training group.

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.

The control group will be taught relaxation exercises and will be asked to perform the exercises at home.

Outcomes

Primary Outcome Measures

Mobility
Timed Up and Go Test
Modified Sensory Organization Test
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.
Upper extremity function
9-Hole Peg Test
cognitive function
The Brief Repeatable Battery of Neuropsychological Tests

Secondary Outcome Measures

Physical Activity
International Physical Activity Questionnaire- Long version
Fatigue Impact
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).
Fatigue Severity
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.
Balance Confidence
Activities-specific Balance Confidence (ABC) is a scale in which the patient rates his perceived level of confidence while performing 16 daily living activities.
Neuropsychological Questionnaire
Multiple Sclerosis Neuropsychological Questionnaire - MSNQ

Full Information

First Posted
April 19, 2018
Last Updated
July 29, 2019
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT03512886
Brief Title
The Effect of Multiple-Task Training in Patients With Multiple Sclerosis
Official Title
The Effect of Multiple-Task Training on Physical and Cognitive Functions in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
July 4, 2019 (Actual)
Study Completion Date
July 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Multi-task training, Balance, Mobility, Cognition, Upper extremity function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single task training
Arm Type
Active Comparator
Arm Description
The exercise program consisting of 10 different motor tasks will be implemented in a single task training group.
Arm Title
Multi-task training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will be taught relaxation exercises and will be asked to perform the exercises at home.
Intervention Type
Other
Intervention Name(s)
Multi-task training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Single task training
Intervention Description
An exercise program consisting of 10 different motor tasks will be implemented in a single task training group.
Primary Outcome Measure Information:
Title
Mobility
Description
Timed Up and Go Test
Time Frame
ten minutes]
Title
Modified Sensory Organization Test
Description
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.
Time Frame
Fifteen minutes]
Title
Upper extremity function
Description
9-Hole Peg Test
Time Frame
ten minutes
Title
cognitive function
Description
The Brief Repeatable Battery of Neuropsychological Tests
Time Frame
thirty minutes
Secondary Outcome Measure Information:
Title
Physical Activity
Description
International Physical Activity Questionnaire- Long version
Time Frame
ten minutes
Title
Fatigue Impact
Description
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).
Time Frame
five minutes
Title
Fatigue Severity
Description
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.
Time Frame
Five minutes
Title
Balance Confidence
Description
Activities-specific Balance Confidence (ABC) is a scale in which the patient rates his perceived level of confidence while performing 16 daily living activities.
Time Frame
five minutes
Title
Neuropsychological Questionnaire
Description
Multiple Sclerosis Neuropsychological Questionnaire - MSNQ
Time Frame
one minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cagla Ozkul
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16445340
Citation
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Results Reference
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PubMed Identifier
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Citation
Pashler H. Dual-task interference in simple tasks: data and theory. Psychol Bull. 1994 Sep;116(2):220-44. doi: 10.1037/0033-2909.116.2.220.
Results Reference
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PubMed Identifier
12669744
Citation
Tombu M, Jolicoeur P. A central capacity sharing model of dual-task performance. J Exp Psychol Hum Percept Perform. 2003 Feb;29(1):3-18. doi: 10.1037//0096-1523.29.1.3.
Results Reference
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PubMed Identifier
25839039
Citation
Wajda DA, Sosnoff JJ. Cognitive-motor interference in multiple sclerosis: a systematic review of evidence, correlates, and consequences. Biomed Res Int. 2015;2015:720856. doi: 10.1155/2015/720856. Epub 2015 Mar 9.
Results Reference
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PubMed Identifier
28933609
Citation
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Citation
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Citation
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Citation
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The Effect of Multiple-Task Training in Patients With Multiple Sclerosis

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