- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05526287
Effects of Dual-Task Training in People With Multiple Sclerosis
Effects of Dual-Task Training on Balance, Gait, Dual-Task Performance, Cognitive Function, Fatigue in People With Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karsıyaka
-
Izmir, Karsıyaka, Turkey (Türkiye), 35575
- Ege University Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
Home exercise program includes lower extremity, core stability and balance exercises and will be performed three times a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
eight weeks
|
|
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.
|
eight weeks
|
|
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.
|
eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
eight weeks
|
|
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.
|
eight weeks
|
|
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.
|
eight weeks
|
|
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.
|
eight weeks
|
|
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.
|
eight weeks
|
|
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.
|
eight weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nur YUCEYAR, MD, Ege university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOzkeskin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.