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Clinical Trials/NCT03505294
NCT03505294
Completed
Not Applicable

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

Gazi University1 site in 1 country20 target enrollmentJune 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Gazi University
Enrollment
20
Locations
1
Primary Endpoint
cognitive function
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 18, 2018
End Date
December 24, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cagla Ozkul

Research Assistant

Gazi University

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

Outcomes

Primary Outcomes

cognitive function

Time Frame: thirty minutes

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.

Walking ability

Time Frame: Five minutes

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).

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.

upper extremity function

Time Frame: ten minutes

9-Hole Peg Test

mobility

Time Frame: ten minutes

Timed Up and Go Test

Gait Assessment

Time Frame: ten minutes

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.

Secondary Outcomes

  • Balance Confidence(Five minutes)
  • Balance Scale(ten minutes)
  • Fatigue Impact(Five minutes)
  • Fatigue Severity(five minutes)
  • Physical Activity(ten minutes)
  • Neuropsychological Questionnaire(one minute)

Study Sites (1)

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