Dual-Task Performance in Patients With Multiple Sclerosis

NCT ID: NCT03508284

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-18

Study Completion Date

2019-05-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with Multiple Sclerosis

MS patients (EDSS: 0-5,5)

No interventions assigned to this group

Healthy group

Healthy individuals without chronic disease

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Cagla Ozkul

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cagla Ozkul

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23200463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11990874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19007738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20594850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19026963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28138492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14527120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24578463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11548987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12617275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17293726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17337007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12900694 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 13688369 (View on PubMed)

Idiman E, Uzunel F, Ozakbas S, Yozbatiran N, Oguz M, Callioglu B, Gokce N, Bahar Z. Cross-cultural adaptation and validation of multiple sclerosis quality of life questionnaire (MSQOL-54) in a Turkish multiple sclerosis sample. J Neurol Sci. 2006 Jan 15;240(1-2):77-80. doi: 10.1016/j.jns.2005.09.009. Epub 2005 Nov 8.

Reference Type BACKGROUND
PMID: 16277993 (View on PubMed)

Other Identifiers

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230

Identifier Type: -

Identifier Source: org_study_id

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