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

Study Overview
=================
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.

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

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Task-oriented training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, single-blind trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Task-oriented training<br>Task-oriented training consisting of 10 different motor tasks will be applied. | Other: Task-oriented training<br>* 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.<br>|
| No Intervention: Control group<br>The control group will be taught relaxation exercises and will be asked to perform. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | ten minutes | 
| 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). | Five minutes | 
| mobility | Timed Up and Go Test | ten minutes | 
| 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. | Fifteen minutes | 
| upper extremity function | 9-Hole Peg Test | ten minutes | 
| 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. | thirty minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | ten minutes | 
| 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. | Five minutes | 
| 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. | five minutes | 
| 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). | Five minutes | 
| 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. | ten minutes | 
| Neuropsychological Questionnaire | Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) is a self-administered 15-item questionnaire that measure of neuropsychological functioning in everyday life. | one minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, task-oriented training, physical performance, cognition