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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512886
• Other study ID #: 231
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: July 25, 2019

Study information

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

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 25, 2019
• Est. primary completion date: July 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Multi-task training
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
An exercise program consisting of 10 different motor tasks will be implemented in a single task training group.

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 (12)

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

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

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

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

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

Pashler H. Dual-task interference in simple tasks: data and theory. Psychol Bull. 1994 Sep;116(2):220-44. Review. — View Citation

Silsupadol P, Siu KC, Shumway-Cook A, Woollacott MH. Training of balance under single- and dual-task conditions in older adults with balance impairment. Phys Ther. 2006 Feb;86(2):269-81. — View Citation

Sosnoff JJ, Wajda DA, Sandroff BM, Roeing KL, Sung J, Motl RW. Dual task training in persons with Multiple Sclerosis: a feasability randomized controlled trial. Clin Rehabil. 2017 Oct;31(10):1322-1331. doi: 10.1177/0269215517698028. Epub 2017 Mar 20. — View Citation

Tombu M, Jolicoeur P. A central capacity sharing model of dual-task performance. J Exp Psychol Hum Percept Perform. 2003 Feb;29(1):3-18. Review. — View Citation

Wajda DA, Sosnoff JJ. Cognitive-motor interference in multiple sclerosis: a systematic review of evidence, correlates, and consequences. Biomed Res Int. 2015;2015:720856. doi: 10.1155/2015/720856. Epub 2015 Mar 9. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility	Timed Up and Go Test	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.	Fifteen minutes]
Primary	Upper extremity function	9-Hole Peg Test	ten minutes
Primary	cognitive function	The Brief Repeatable Battery of Neuropsychological Tests	thirty minutes
Secondary	Physical Activity	International Physical Activity Questionnaire- Long version	ten minutes
Secondary	Fatigue Impact	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).	five 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	Neuropsychological Questionnaire	Multiple Sclerosis Neuropsychological Questionnaire - MSNQ	one minute