Dual-Task Performance in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508284
• Other study ID #: 230
• Status: Completed
• Start date: June 18, 2018
• Est. completion date: May 18, 2019

Study information

• Verified date: July 2019
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 18, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (16)

Armutlu K, Keser I, Korkmaz N, Akbiyik DI, Sümbüloglu V, Güney 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. Epub 2007 Mar 6. — View Citation

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. — View Citation

BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. — View Citation

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. — View Citation

Boringa JB, Lazeron RH, Reuling IE, Adèr 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. — View Citation

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. — View Citation

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. Review. — View Citation

Craig CL, Marshall AL, Sjöström 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Nov 8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	ten minutes
Primary	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)	Fifteen minutes
Primary	upper extremity function	9-Hole Peg Test; Cognitive additional task (arithmetic); Cognitive additional task (verbal)	ten minutes
Secondary	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.	5-10 minutes
Secondary	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.	Five minutes
Secondary	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.	five minutes
Secondary	Mood	Beck's Depression Inventory	one minute
Secondary	Visual attention and task switching	Trail Making Test	Five minutes
Secondary	selective attention	stroop test	Five minutes
Secondary	cognitive function	The Brief Repeatable Battery of Neuropsychological Tests	thirty minutes