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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 19, 2018
First Posted Date  ICMJE April 23, 2018
Last Update Posted Date January 30, 2019
Actual Study Start Date  ICMJE June 18, 2018
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2018)
  • 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.
  • 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).
  • mobility [ Time Frame: ten minutes ]
    Timed Up and Go Test
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • Gait Assessment [ Time Frame: ten minutes ]
    The Functional Gait Assessment
  • Walking ability [ Time Frame: Five minutes ]
    The 12-item Multiple Sclerosis Walking Scale (MSWS-12)
  • mobility [ Time Frame: ten minutes ]
    Timed Up and Go Test
  • 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
  • cognitive function [ Time Frame: thirty minutes ]
    The Brief Repeatable Battery of Neuropsychological Tests
Change History Complete list of historical versions of study NCT03505294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2018)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • 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.
  • 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.
  • 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.
  • 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).
  • Physical Activity [ Time Frame: ten minutes ]
    International Physical Activity Questionnaire- Long version
  • Neuropsychological Questionnaire [ Time Frame: one minute ]
    Multiple Sclerosis Neuropsychological Questionnaire - MSNQ
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Task-Oriented Training in Patients With Multiple Sclerosis
Official Title  ICMJE The Effect of Task-Oriented Training on the Physical and Cognitive Functions in Patients With Multiple Sclerosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Task-oriented training
    "Task-oriented training" consisting of 10 different motor tasks will be applied.
    Intervention: Other: Task-oriented training
  • No Intervention: Control group
    The control group will be taught relaxation exercises and will be asked to perform.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 24, 2018
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03505294
Other Study ID Numbers  ICMJE 229
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cagla Ozkul, Gazi University
Study Sponsor  ICMJE Gazi University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cagla Ozkul Gazi University
PRS Account Gazi University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP