NCT03512886

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

April 19, 2018

Last Update Submit

July 29, 2019

Conditions

Keywords

Multiple sclerosisMulti-task trainingBalanceMobilityCognitionUpper extremity function

Outcome Measures

Primary Outcomes (4)

  • Mobility

    Timed Up and Go Test

    ten minutes]

  • 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]

  • Upper extremity function

    9-Hole Peg Test

    ten minutes

  • cognitive function

    The Brief Repeatable Battery of Neuropsychological Tests

    thirty minutes

Secondary Outcomes (5)

  • Physical Activity

    ten minutes

  • Fatigue Impact

    five minutes

  • Fatigue Severity

    Five minutes

  • Balance Confidence

    five minutes

  • Neuropsychological Questionnaire

    one minute

Study Arms (3)

Single task training

ACTIVE COMPARATOR

The exercise program consisting of 10 different motor tasks will be implemented in a single task training group.

Other: Single task training

Multi-task training

EXPERIMENTAL

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.

Other: Multi-task training

Control group

NO INTERVENTION

The control group will be taught relaxation exercises and will be asked to perform the exercises at home.

Interventions

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.

Multi-task training

An exercise program consisting of 10 different motor tasks will be implemented in a single task training group.

Single task training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants who have orthopedic, vision, hearing, or perception problems
  • Patients who have any cardiovascular or pulmonary disease in which exercise is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (13)

  • 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.

    PMID: 16445340BACKGROUND
  • Pashler H. Dual-task interference in simple tasks: data and theory. Psychol Bull. 1994 Sep;116(2):220-44. doi: 10.1037/0033-2909.116.2.220.

    PMID: 7972591BACKGROUND
  • 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. doi: 10.1037//0096-1523.29.1.3.

    PMID: 12669744BACKGROUND
  • 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.

    PMID: 25839039BACKGROUND
  • 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.

    PMID: 28933609BACKGROUND
  • 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.

    PMID: 28138492BACKGROUND
  • 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.

    PMID: 14527120BACKGROUND
  • 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.

    PMID: 11548987BACKGROUND
  • 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.

    PMID: 12617275BACKGROUND
  • 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.

    PMID: 17293726BACKGROUND
  • 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.

    PMID: 17337007BACKGROUND
  • 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.

    PMID: 12900694BACKGROUND
  • Ozkul C, Eldemir K, Apaydin Y, Gulsen C, Irkec C, Guclu-Gunduz A. Effects of multi-task training on motor and cognitive performances in multiple sclerosis patients without clinical disability: a single-blinded randomized controlled trial. Acta Neurol Belg. 2023 Aug;123(4):1301-1312. doi: 10.1007/s13760-023-02172-7. Epub 2023 Jan 7.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Cagla Ozkul

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 1, 2018

Study Start

June 18, 2018

Primary Completion

July 4, 2019

Study Completion

July 25, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations