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Effects of Dual-Task Training in People With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05526287
Recruitment Status : Recruiting
First Posted : September 2, 2022
Last Update Posted : November 23, 2022
Sponsor:
Information provided by (Responsible Party):
Mehmet Ozkeskin, Ege University

Brief Summary:
The purpose of this study is to investigate the effects of dual task training on balance, gait, dual-task performance, cognitive function, fatigue and functional mobility in people with Multiple Sclerosis(MS).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Dual-Task Training Other: Home Exercise Program Not Applicable

Detailed Description:
Eligible participants will be randomized to dual-task group or control group. Dual-task group will receive 8 weeks of dual-task training twice a week and home exercise program. Control group will receive only home exercise program for 8 weeks. Each participant will be assessed before and after the 8 weeks of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dual-Task Training on Balance, Gait, Dual-Task Performance, Cognitive Function, Fatigue in People With Multiple Sclerosis
Actual Study Start Date : November 1, 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dual-Task Group
Participants will receive 8 weeks of dual-task training twice a week and home exercise program.Dual-task training will include motor-motor and motor-cognitive dual-task activities.Home exercise program will include core and lower extremity exercises.Home exercises will be performed three times a week.
Other: Dual-Task Training

Dual-task training sessions include; walking on treadmill for 10-30 minutes and half of this walking period participants will perform cognitive tasks, cognitive tasks will be repeated on tandem stance position and single leg stance position other half of the session consists of motor-motor dual task activities and gait training on firm and soft surfaces.

Home exercise program includes lower extremity, core stability and balance exercises and will be performed three times a week.


Active Comparator: Control Group
Participants will receive 8 weeks of home exercise program.Home exercise program will include core and lower extremity exercises.Home exercises will be performed three times a week.
Other: Home Exercise Program
Home exercise program includes lower extremity, core stability and balance exercises and will be performed three times a week.




Primary Outcome Measures :
  1. Berg Balance Scale(BBS) [ Time Frame: eight weeks ]
    BBS, evaluates daily activities including static sitting and standing balance, as well as transfers, turning, and picking up objects from the ground, in 14 items.Scoring is given as 0-4. It scores from 4 (normal performance) to 0 (not able to do the movement) according to the person's ability to do what is asked of them safely and independently. The total score is 56 points. 0-20 indicates high risk, 21-40 indicates medium risk, and 41-64 indicates low risk.

  2. Timed Up And Go Test (TUG) [ Time Frame: eight weeks ]
    It is a frequently used test that evaluates functional mobility and dynamic balance. At the beginning of the test, individuals sit in a chair. A distance of 3 m is set in front of the patient. With the start command, the patient gets up from his seat and walks 3 m, turns around and walks back and sits. With the start command, the time until the moment of sitting on the chair is recorded in seconds.Shorter duration indicates better functional mobility.

  3. Tetrax((Sunlight Medical Ltd, Israel),Computerized Static Posturography Device [ Time Frame: eight weeks ]
    Tetrax (Sunlight Medical Ltd, Israel) computerized posturography device consists of a platform system where data is collected, a computer and software system where data is processed and integrated. Participants will stand on the platform system in 8 different condition. Tetrax will be used to measure static balance and fall risk.


Secondary Outcome Measures :
  1. MS Walking Scale-12(MSWS-12) [ Time Frame: eight weeks ]
    MSWS-12 is a 12-item scale evaluating the effect of MS on person's walking ability. MSWS-12 is scored between 12-54. Higher scores indicate more negatively affected walking ability.

  2. Fatigue Severity Index(FSI) [ Time Frame: eight weeks ]
    The scale consists of 9 questions and each question is graded over 7 points.FSI is scored between 0-63. Higher scores indicate more fatigue.

  3. Brief International Cognitive Assesment for MS(BICAMS) [ Time Frame: eight weeks ]
    BICAMS includes Symbol Digit Modalities Test (SDMT), California Verbal Learning Test II (CVLT-II) and Brief Visuospatial Memory Test-Revised (BVMT-R). The total score is determined by summing the scores of the 3 tests. Battery will be used to evaluate cognitive function. Higher scores indicate better cognitive function.

  4. 10 Meter Walking Test(10MWT) [ Time Frame: eight weeks ]
    This test calculates the unassisted walking speed of individuals at a distance of 10 meters. In this test, the person will be asked to walk at their normal pace in a pre-measured 10 meter area.

  5. Dual-Task Performance [ Time Frame: eight weeks ]
    Dual-Task performance will be measured with TUG-cognitive and 10MWT-motor. In TUG-cognitive,patient will be counting down by three from a number between 100 and 200 while performing Timed-Up and Go test. In 10MWT-motor,patient will be carrying a tray with 3 water filled 200 ml plastic glasses while walking a 10 m distance.Time will be measured. Longer time to complete task indicates lower dual-task performance.

  6. Dual-Task Questionnaire(DTQ) [ Time Frame: eight weeks ]
    The Dual Task Questionnaire assesses the frequency of difficulties experienced by individuals with neurological injury or disease during activities of daily living that involve dual tasks. DTQ is scored between 0-40. Higher scores indicate more frequent dual-task difficulties.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having a definitive diagnosis of MS according to the revised McDonald criteria
  • Having Expanded Disability Status Scale score between 0-5.5
  • No relapse in the last 30 days
  • Having a Mini Mental Test score of 24 and above
  • Being fluent in Turkish language
  • No condition that prevents exercising

Exclusion Criteria:

  • Being pregnant
  • Presence of a neuro-musculoskeletal disease other than Multiple Sclerosis
  • Having received physiotherapy for balance and gait disorders in the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05526287


Contacts
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Contact: Mehmet OZKESKIN, PhD +905056631833 mehmet.ozkeskin99@gmail.com
Contact: Ece EKICI, BSc +905300733826 ekiciece@gmail.com

Locations
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Turkey
Ege University Faculty of Health Sciences Recruiting
İzmir, Karsıyaka, Turkey, 35575
Contact: MEHMET OZKESKIN, PhD    +905056631833    mehmet.ozkeskin99@gmail.com   
Contact: ECE EKICI, BSc    +905300733826    ekiciece@gmail.com   
Sponsors and Collaborators
Ege University
Investigators
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Study Chair: Nur YUCEYAR, MD Ege University
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Responsible Party: Mehmet Ozkeskin, Assistant Professor, Ege University
ClinicalTrials.gov Identifier: NCT05526287    
Other Study ID Numbers: MOzkeskin
First Posted: September 2, 2022    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Ozkeskin, Ege University:
Multiple Sclerosis
Balance
Gait
Dual-Task
Cognitive Function
Functional Mobility
Activities of Daily Living
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases