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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Task-oriented 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, task-oriented training, physical performance, cognition

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 2-5,5.

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 Type

Experimental

No Intervention

Arm Label

Task-oriented training

Control group

Arm Description

"Task-oriented training" consisting of 10 different motor tasks will be applied.

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

Outcomes

Primary Outcome Measures

Gait Assessment
The Functional Gait Assessment is a 10-item walking-based balance test, with each item scored 0 to 3. The high score shows that the balance is better.
Walking ability
The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-assessment scale. During the last 2 weeks 12 problems that can occur during walking due to MS are evaluated (1:no limitation, 5:extreme limitation).
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 consists of the Selective Reminding Test, the 10/36 Spatial Recall Test, the Symbol Digit Modalities Test, the Paced Auditory Serial Addition Test and the Word List Generation Test.

Secondary Outcome Measures

Balance Scale
Berg Balance Scale (BBS) rates performance from 0 (cannot perform) to 4 (normal performance) on 14 items. It has shown to be a valid measure with high inter and interrater reliability for people with MS.
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.
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.
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).
Physical Activity
International Physical Activity Questionnaire- Long version (IPAQ) measures total physical activity domains including work-related, transport-related activity, leisure-time, domestic and gardening (yard) activities over the last 7 days. The total scores for each activity type including walking, moderate-intensity activities, and vigorous-intensity activities were calculated by using the answers given to these domains.
Neuropsychological Questionnaire
Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) is a self-administered 15-item questionnaire that measure of neuropsychological functioning in everyday life.

Full Information

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

Unique Protocol Identification Number
NCT03505294
Brief Title
The Effect of Task-Oriented Training in Patients With Multiple Sclerosis
Official Title
The Effect of Task-Oriented Training on the Physical and Cognitive Functions in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 24, 2018 (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
It is reported that 85% of MS patients have gait disturbance, 87.9% balance, 35-90% fatigue and 45-60% cognitive problems. Rehabilitation approaches based on the motor control systems model, the plasticity concept, the motor learning principles, have been found to be effective for solving these problems. With these rehabilitation approaches, it is aimed to develop the ability of the person to meet the task and environmental demands and to realize the highest quality and the right function with maximum potential by consuming the least energy in different environmental conditions of different tasks. "Task-oriented training" may be one of the most effective among the evidence-based rehabilitation approaches for these goals. The purpose of this study is to determine the effect of "Task-Oriented Training" on the physical and cognitive functions in patients with multiple sclerosis.
Detailed Description
The study was designed as a randomized, controlled, single-blind trial. The patients will be randomly assigned to two groups, the "task-oriented training" group, and the control group. "Task-oriented training" consisting of 10 different motor tasks including lower extremity and upper extremity activities will be applied to the training group twice a week for 6 weeks. The control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 6 weeks at home. 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, task-oriented training, physical performance, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, single-blind trial
Masking
Outcomes Assessor
Masking Description
To ensure blinding, the assessor physiotherapist will not be aware of the arm to which the subjects belong.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Task-oriented training
Arm Type
Experimental
Arm Description
"Task-oriented training" consisting of 10 different motor tasks will be applied.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will be taught relaxation exercises and will be asked to perform.
Intervention Type
Other
Intervention Name(s)
Task-oriented training
Intervention Description
"Task-oriented training" consisting of 10 different motor tasks including lower extremity and upper extremity activities will be applied to the training group twice a week for 6 weeks.
Primary Outcome Measure Information:
Title
Gait Assessment
Description
The Functional Gait Assessment is a 10-item walking-based balance test, with each item scored 0 to 3. The high score shows that the balance is better.
Time Frame
ten minutes
Title
Walking ability
Description
The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-assessment scale. During the last 2 weeks 12 problems that can occur during walking due to MS are evaluated (1:no limitation, 5:extreme limitation).
Time Frame
Five minutes
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 consists of the Selective Reminding Test, the 10/36 Spatial Recall Test, the Symbol Digit Modalities Test, the Paced Auditory Serial Addition Test and the Word List Generation Test.
Time Frame
thirty minutes
Secondary Outcome Measure Information:
Title
Balance Scale
Description
Berg Balance Scale (BBS) rates performance from 0 (cannot perform) to 4 (normal performance) on 14 items. It has shown to be a valid measure with high inter and interrater reliability for people with MS.
Time Frame
ten 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
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
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
Physical Activity
Description
International Physical Activity Questionnaire- Long version (IPAQ) measures total physical activity domains including work-related, transport-related activity, leisure-time, domestic and gardening (yard) activities over the last 7 days. The total scores for each activity type including walking, moderate-intensity activities, and vigorous-intensity activities were calculated by using the answers given to these domains.
Time Frame
ten minutes
Title
Neuropsychological Questionnaire
Description
Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) is a self-administered 15-item questionnaire that measure of neuropsychological functioning in everyday life.
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 2-5,5. 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
25248447
Citation
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Citation
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Results Reference
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27794631
Citation
Salci Y, Fil A, Armutlu K, Yildiz FG, Kurne A, Aksoy S, Nurlu G, Karabudak R. Effects of different exercise modalities on ataxia in multiple sclerosis patients: a randomized controlled study. Disabil Rehabil. 2017 Dec;39(26):2626-2632. doi: 10.1080/09638288.2016.1236411. Epub 2016 Oct 29.
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
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The Effect of Task-Oriented Training in Patients With Multiple Sclerosis

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