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Multiple SclerosisNCT03505294

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

A study testing Task-oriented training in people with 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

It is reported that 85% of MS patients have gait disturbance, 87.9% balance, 35-90% fatigue and 45-60% cognitive problems. Rehabilitation approaches based on the motor control systems model, the plasticity concept, the motor learning principles, have been found to be effective for solving these problems. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Task-oriented training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Jun 2018to 24 Dec 2018
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 2-5,5.

Who cannot join

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

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

It is reported that 85% of MS patients have gait disturbance, 87.9% balance, 35-90% fatigue and 45-60% cognitive problems. Rehabilitation approaches based on the motor control systems model, the plasticity concept, the motor learning principles, have been found to be effective for solving these problems. With these rehabilitation approaches, it is aimed to develop the ability of the person to meet the task and environmental demands and to realize the highest quality and the right function with maximum potential by consuming the least energy in different environmental conditions of different tasks. "Task-oriented training" may be one of the most effective among the evidence-based rehabilitation approaches for these goals.

The purpose of this study is to determine the effect of "Task-Oriented Training" on the physical and cognitive functions in patients with multiple sclerosis.

Read the detailed description

The study was designed as a randomized, controlled, single-blind trial. The patients will be randomly assigned to two groups, the "task-oriented training" group, and the control group. "Task-oriented training" consisting of 10 different motor tasks including lower extremity and upper extremity activities will be applied to the training group twice a week for 6 weeks. The control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 6 weeks at home.

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.

Being tested
Task-oriented training
Keywords
Multiple Sclerosis, task-oriented training, physical performance, 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.

  • Task-oriented trainingOther

    "Task-oriented training" consisting of 10 different motor tasks including lower extremity and upper extremity activities will be applied to the training group twice a week for 6 weeks.

Study groups in NCT03505294
Study groupRoleWhat they receive
Task-oriented trainingExperimental"Task-oriented training" consisting of 10 different motor tasks will be applied.
Receives: Other: Task-oriented training
Control groupNo interventionThe control group will be taught relaxation exercises and will be asked to perform.

What is being measured

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

  1. Gait Assessment

    The Functional Gait Assessment is a 10-item walking-based balance test, with each item scored 0 to 3. The high score shows that the balance is better.

    Measured: ten minutes

  2. Walking ability

    The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-assessment scale. During the last 2 weeks 12 problems that can occur during walking due to MS are evaluated (1:no limitation, 5:extreme limitation).

    Measured: Five minutes

  3. mobility

    Timed Up and Go Test

    Measured: ten minutes

  4. 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.

    Measured: Fifteen minutes

  5. upper extremity function

    9-Hole Peg Test

    Measured: ten minutes

  6. cognitive function

    The Brief Repeatable Battery of Neuropsychological Tests consists of the Selective Reminding Test, the 10/36 Spatial Recall Test, the Symbol Digit Modalities Test, the Paced Auditory Serial Addition Test and the Word List Generation Test.

    Measured: thirty minutes

Secondary outcomes (6)

  1. Balance Scale

    Berg Balance Scale (BBS) rates performance from 0 (cannot perform) to 4 (normal performance) on 14 items. It has shown to be a valid measure with high inter and interrater reliability for people with MS.

    Measured: ten minutes

  2. 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

  3. 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

  4. 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).

    Measured: Five minutes

  5. Physical Activity

    International Physical Activity Questionnaire- Long version (IPAQ) measures total physical activity domains including work-related, transport-related activity, leisure-time, domestic and gardening (yard) activities over the last 7 days. The total scores for each activity type including walking, moderate-intensity activities, and vigorous-intensity activities were calculated by using the answers given to these domains.

    Measured: ten minutes

  6. Neuropsychological Questionnaire

    Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) is a self-administered 15-item questionnaire that measure of neuropsychological functioning in everyday life.

    Measured: one minute

Timeline

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

  1. First posted23 Apr 2018
  2. Study start18 Jun 2018
  3. Primary completion30 Nov 2018
  4. Study completion24 Dec 2018

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, controlled, single-blind trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03505294
Sponsor's protocol ID
229
Status last verified
Jan 2019
First submitted
19 Apr 2018
Last updated
30 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chisari C, Venturi M, Bertolucci F, Fanciullacci C, Rossi B. Benefits of an intensive task-oriented circuit training in Multiple Sclerosis patients with mild disability. NeuroRehabilitation. 2014;35(3):509-18. doi: 10.3233/NRE-141144.

    PubMed 25248447

  • Straudi S, Martinuzzi C, Pavarelli C, Sabbagh Charabati A, Benedetti MG, Foti C, Bonato M, Zancato E, Basaglia N. A task-oriented circuit training in multiple sclerosis: a feasibility study. BMC Neurol. 2014 Jun 7;14:124. doi: 10.1186/1471-2377-14-124.

    PubMed 24906545

  • Salci Y, Fil A, Armutlu K, Yildiz FG, Kurne A, Aksoy S, Nurlu G, Karabudak R. Effects of different exercise modalities on ataxia in multiple sclerosis patients: a randomized controlled study. Disabil Rehabil. 2017 Dec;39(26):2626-2632. doi: 10.1080/09638288.2016.1236411. Epub 2016 Oct 29.

    PubMed 27794631

  • Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. doi: 10.1519/00139143-200831010-00006.

    PubMed 18489806

  • Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.

    PubMed 7814786

  • Walker ML, Austin AG, Banke GM, Foxx SR, Gaetano L, Gardner LA, McElhiney J, Morris K, Penn L. Reference group data for the functional gait assessment. Phys Ther. 2007 Nov;87(11):1468-77. doi: 10.2522/ptj.20060344. Epub 2007 Sep 4.

    PubMed 17785375

  • Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.

    PubMed 12525714

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Task-oriented training in people with 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 1 inclusion and 2 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 30 Jan 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?

Gait Assessment (time frame: ten minutes). The study lists 6 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 NCT03505294, which also lists 13 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 30 Jan 2019.

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