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

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ClinicalTrials.gov Identifier: NCT03505294
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Cagla Ozkul, Gazi University

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Task-oriented training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, single-blind trial
Masking: Single (Outcomes Assessor)
Masking Description: To ensure blinding, the assessor physiotherapist will not be aware of the arm to which the subjects belong.
Primary Purpose: Treatment
Official Title: The Effect of Task-Oriented Training on the Physical and Cognitive Functions in Patients With Multiple Sclerosis
Actual Study Start Date : June 18, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : December 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Task-oriented training
"Task-oriented training" consisting of 10 different motor tasks will be applied.
Other: Task-oriented training
"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.

No Intervention: Control group
The control group will be taught relaxation exercises and will be asked to perform.



Primary Outcome Measures :
  1. 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.

  2. 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).

  3. mobility [ Time Frame: ten minutes ]
    Timed Up and Go Test

  4. 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.

  5. upper extremity function [ Time Frame: ten minutes ]
    9-Hole Peg Test

  6. 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.


Secondary Outcome Measures :
  1. Balance Scale [ Time Frame: ten minutes ]
    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.

  2. Balance Confidence [ Time Frame: Five minutes ]
    Activities-specific Balance Confidence (ABC) is a scale in which the patient rates his perceived level of confidence while performing 16 daily living activities.

  3. Fatigue Severity [ Time Frame: five minutes ]
    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.

  4. Fatigue Impact [ Time Frame: Five minutes ]
    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).

  5. Physical Activity [ Time Frame: ten minutes ]
    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.

  6. Neuropsychological Questionnaire [ Time Frame: one minute ]
    Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) is a self-administered 15-item questionnaire that measure of neuropsychological functioning in everyday life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505294


Locations
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Turkey
Gazi University
Ankara, Turkey
Sponsors and Collaborators
Gazi University
Investigators
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Principal Investigator: Cagla Ozkul Gazi University

Publications:

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Responsible Party: Cagla Ozkul, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT03505294     History of Changes
Other Study ID Numbers: 229
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cagla Ozkul, Gazi University:
Multiple Sclerosis
task-oriented training
physical performance
cognition

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases