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Completed

NCT Number: NCT03512886

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

The Activities of Daily Living requires the ability to perform multiple activities at the same time, not just the motor or cognitive activity. When many tasks are performed at the same time, the attention capacity is effectively used and attention is shared according to the difficulty and priority of the tasks. There is evidence that patients with Multiple Sclerosis (MS) have reduced performance during multitasking.

In this study, the investigators aim to investigate the effect of multitasking training on balance, mobility, upper extremity performance and cognitive functions in patients with MS.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

Patients with MS between 0-1,5 score according to the Extended Disability Status Scale (EDSS) will be included in the study. The balance, mobility, upper extremity performance, the cognitive function will be evaluated twice.

The study was designed as a prospective, randomized controlled study. The patients will be randomly assigned to three groups, the "multi-task training (MT)" group, the "single task training (ST)" group, and "control" group. The training will be twice a week for 6 weeks.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 0-1,5.

Exclusion criteria

  • Participants who have orthopedic, vision, hearing, or perception problems
  • Patients who have any cardiovascular or pulmonary disease in which exercise is contraindicated

Treatment and study plan

Multi-task training

Other

In the multitasking training group, a second motor task in the first two weeks, a cognitive task in the third and fourth week, both motor and cognitive tasks in the last two weeks will be added to these 10 different motor tasks.

Single task training

Other

An exercise program consisting of 10 different motor tasks will be implemented in a single task training group.

Primary outcomes

  1. Mobility

    Time frame: ten minutes]

    Timed Up and Go Test

  2. 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.

  3. Upper extremity function

    Time frame: ten minutes

    9-Hole Peg Test

  4. cognitive function

    Time frame: thirty minutes

    The Brief Repeatable Battery of Neuropsychological Tests

Secondary outcomes

  1. Physical Activity

    Time frame: ten minutes

    International Physical Activity Questionnaire- Long version

  2. 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).

  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. 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.

  5. Neuropsychological Questionnaire

    Time frame: one minute

    Multiple Sclerosis Neuropsychological Questionnaire - MSNQ

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 1, 2018
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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