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Multiple SclerosisNCT03508284

Dual-Task Performance in Patients With Multiple Sclerosis

An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Jun 2018to 18 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: MS patients who apply to the Neurological Rehabilitation Unit of Gazi University Faculty of Health Sciences will be invited to this study.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gazi University

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Factors Associated With 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.

Read the detailed description

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.

Keywords
Multiple sclerosis, Dual-task, Balance, Mobility, Cognition
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03508284
Study groupRoleWhat they receive
Patients with Multiple SclerosisMS patients (EDSS: 0-5,5)
Healthy groupHealthy individuals without chronic disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Timed Up and Go Test

    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.

    Measured: ten minutes

  2. Modified Sensory Organization Test

    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)

    Measured: Fifteen minutes

  3. upper extremity function

    9-Hole Peg Test

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

    Measured: ten minutes

Secondary outcomes (7)

  1. Sleep Quality: PSQI

    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.

    Measured: 5-10 minutes

  2. Fatigue Severity

    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.

    Measured: Five minutes

  3. Balance Confidence

    Activities-specific Balance Confidence (ABC) is a scale in which the patient rates his perceived level of confidence while performing 16 daily living activities.

    Measured: five minutes

  4. Mood

    Beck's Depression Inventory

    Measured: one minute

  5. Visual attention and task switching

    Trail Making Test

    Measured: Five minutes

  6. selective attention

    stroop test

    Measured: Five minutes

  7. cognitive function

    The Brief Repeatable Battery of Neuropsychological Tests

    Measured: thirty minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2018
  2. Study start18 Jun 2018
  3. Primary completion16 May 2019
  4. Study completion18 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03508284
Sponsor's protocol ID
230
Status last verified
Jul 2019
First submitted
16 Apr 2018
Last updated
31 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hebert JR, Corboy JR. The association between multiple sclerosis-related fatigue and balance as a function of central sensory integration. Gait Posture. 2013 May;38(1):37-42. doi: 10.1016/j.gaitpost.2012.10.015. Epub 2012 Nov 28.

    PubMed 23200463

  • Mostert S, Kesselring J. Effects of a short-term exercise training program on aerobic fitness, fatigue, health perception and activity level of subjects with multiple sclerosis. Mult Scler. 2002 Apr;8(2):161-8. doi: 10.1191/1352458502ms779oa.

    PubMed 11990874

  • Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.

    PubMed 19007738

  • Kalron A, Dvir Z, Achiron A. Walking while talking--difficulties incurred during the initial stages of multiple sclerosis disease process. Gait Posture. 2010 Jul;32(3):332-5. doi: 10.1016/j.gaitpost.2010.06.002. Epub 2010 Jul 1.

    PubMed 20594850

  • Yelnik A, Bonan I. Clinical tools for assessing balance disorders. Neurophysiol Clin. 2008 Dec;38(6):439-45. doi: 10.1016/j.neucli.2008.09.008. Epub 2008 Oct 18.

    PubMed 19026963

  • Hofheinz M, Mibs M. The Prognostic Validity of the Timed Up and Go Test With a Dual Task for Predicting the Risk of Falls in the Elderly. Gerontol Geriatr Med. 2016 Mar 16;2:2333721416637798. doi: 10.1177/2333721416637798. eCollection 2016 Jan-Dec.

    PubMed 28138492

  • Oxford Grice K, Vogel KA, Le V, Mitchell A, Muniz S, Vollmer MA. Adult norms for a commercially available Nine Hole Peg Test for finger dexterity. Am J Occup Ther. 2003 Sep-Oct;57(5):570-3. doi: 10.5014/ajot.57.5.570.

    PubMed 14527120

  • Kaya Y, Aki OE, Can UA, Derle E, Kibaroglu S, Barak A. Validation of Montreal Cognitive Assessment and Discriminant Power of Montreal Cognitive Assessment Subtests in Patients With Mild Cognitive Impairment and Alzheimer Dementia in Turkish Population. J Geriatr Psychiatry Neurol. 2014 Jun;27(2):103-9. doi: 10.1177/0891988714522701. Epub 2014 Feb 26.

    PubMed 24578463

  • Boringa JB, Lazeron RH, Reuling IE, Ader HJ, Pfennings L, Lindeboom J, de Sonneville LM, Kalkers NF, Polman CH. The brief repeatable battery of neuropsychological tests: normative values allow application in multiple sclerosis clinical practice. Mult Scler. 2001 Aug;7(4):263-7. doi: 10.1177/135245850100700409.

    PubMed 11548987

  • Benedict RH, Munschauer F, Linn R, Miller C, Murphy E, Foley F, Jacobs L. Screening for multiple sclerosis cognitive impairment using a self-administered 15-item questionnaire. Mult Scler. 2003 Feb;9(1):95-101. doi: 10.1191/1352458503ms861oa.

    PubMed 12617275

  • Armutlu K, Korkmaz NC, Keser I, Sumbuloglu V, Akbiyik DI, Guney Z, Karabudak R. The validity and reliability of the Fatigue Severity Scale in Turkish multiple sclerosis patients. Int J Rehabil Res. 2007 Mar;30(1):81-5. doi: 10.1097/MRR.0b013e3280146ec4.

    PubMed 17293726

  • Armutlu K, Keser I, Korkmaz N, Akbiyik DI, Sumbuloglu V, Guney Z, Karabudak R. Psychometric study of Turkish version of Fatigue Impact Scale in multiple sclerosis patients. J Neurol Sci. 2007 Apr 15;255(1-2):64-8. doi: 10.1016/j.jns.2007.01.073. Epub 2007 Mar 6.

    PubMed 17337007

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.

    PubMed 13688369

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed Up and Go Test (time frame: ten minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03508284, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019; AzTrials last refreshed its copy on 28 Oct 2026.

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