Clinical trial NCT03505294: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
task-oriented training
physical performance
cognition
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, single-blind trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gait Assessment
timeFrame: ten minutes
measure: Walking ability
timeFrame: Five minutes
measure: mobility
timeFrame: ten minutes
measure: Modified Sensory Organization Test
timeFrame: Fifteen minutes
measure: upper extremity function
timeFrame: ten minutes
measure: cognitive function
timeFrame: thirty minutes
Secondary outcomes:
measure: Balance Scale
timeFrame: ten minutes
measure: Balance Confidence
timeFrame: Five minutes
measure: Fatigue Severity
timeFrame: five minutes
measure: Fatigue Impact
timeFrame: Five minutes
measure: Physical Activity
timeFrame: ten minutes
measure: Neuropsychological Questionnaire
timeFrame: one minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Cagla Ozkul
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chisari C, Venturi M, Bertolucci F, Fanciullacci C, Rossi B. Benefits of an intensive task-oriented circuit training in Multiple Sclerosis patients with mild disability. NeuroRehabilitation. 2014;35(3):509-18. doi: 10.3233/NRE-141144.
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