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Completed

NCT Number: NCT03508284

Dual-Task Performance in Patients With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic inflammatory disease affecting the central nervous system. It is reported that 85% of patients with multiple sclerosis have gait disturbance, 88% balance, and 35-90% fatigue (1, 2, 3). In addition, 65% of patients are reported that their cognitive functions have regressed (4).

It is important to increase the independence of the MS patients in activities of daily living (ADL). Almost all of ADL requires many activities at the same time. For example, toothbrushing involves both the standing balance and the motor activity of the upper limb at the same time. It also requires cognitive tasks such as attention and focusing. Many activities that seem to be the only task are actually multitasking (5).

The aim of this study is to investigate the effects of motor and cognitive additional task on balance, mobility and upper limb performances in MS patients and to determine the factors associated with dual-task performance.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The balance, mobility, upper extremity performance, cognitive function, fatigue, physical activity level, mood, sleep quality, quality of life will be evaluated once.

We will use descriptive statistics and t-tests to compare demographic characteristics between groups and for the categorical variables chi-square. Effect of the group (MS patients or healthy controls), condition (Single task and dual-task conditions), and group × condition interaction will be compared using two-way repeated measures ANOVA. We will examine the correlations between fatigue severity, physical activity level, mood, sleep quality, quality of life using Pearson bivariate correlations. The significance level is set at p<0,05.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants who 18-65 years of age
  • MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.

Exclusion criteria

  • Participants who have orthopedic, vision, hearing, or perception problems

Treatment and study plan

Primary outcomes

  1. Timed Up and Go Test

    Time frame: ten minutes

    Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again.

    Cognitive additional task (arithmetic): Individuals will be asked to perform tasks by counting backward from 3 to 3 from 100.

    Cognitive additional task (verbal): Individuals will be asked to fulfill their duties by producing a vegetable-fruit name.

  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.

    • Cognitive additional task (arithmetic)
    • Cognitive additional task (verbal)

  3. upper extremity function

    Time frame: ten minutes

    9-Hole Peg Test

    • Cognitive additional task (arithmetic)
    • Cognitive additional task (verbal)

Secondary outcomes

  1. Sleep Quality: PSQI

    Time frame: 5-10 minutes

    The Pittsburgh Sleep Quality Index (PSQI) assess sleep quality. It is completed in 5-10 minutes. It consists of seven subscales: subjective sleep efficiency, sleep latency, sleep duration, sleep quality, sleep disturbance, sleep medication use, and daytime dysfunction due to sleepiness. Subscales yield a score from 0 to 3 and PSQI total score of >5 is indicative of poor sleep.

  2. 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.

  3. 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.

  4. Mood

    Time frame: one minute

    Beck's Depression Inventory

  5. Visual attention and task switching

    Time frame: Five minutes

    Trail Making Test

  6. selective attention

    Time frame: Five minutes

    stroop test

  7. cognitive function

    Time frame: thirty minutes

    The Brief Repeatable Battery of Neuropsychological Tests

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Factors Associated With Dual-Task Performance in Patients With Multiple Sclerosis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2018
Registry last updated
Jul 31, 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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