Multiple SclerosisNCT05526287
Effects of Dual-Task Training in People With Multiple Sclerosis
A study testing Dual-Task Training and Home Exercise Program in people with Multiple Sclerosis, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Dual-Task Training and Home Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 15 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Health Sciences
Izmir, Karsıyaka, 35575
About this study
Official title: Effects of Dual-Task Training on Balance, Gait, Dual-Task Performance, Cognitive Function, Fatigue in People With Multiple Sclerosis
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).
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Dual-Task Training, Home Exercise Program
- Keywords
- Multiple Sclerosis, Balance, Gait, Dual-Task, Cognitive Function, Functional Mobility, Activities of Daily Living
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Task TrainingOther
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.
Home Exercise ProgramOther
Home exercise program includes lower extremity, core stability and balance exercises and will be performed three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Dual-Task Group | Experimental | 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. Receives: Other: Dual-Task Training |
| Control Group | Active comparator | 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. Receives: Other: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale(BBS)
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.
Measured: eight weeks
Timed Up And Go Test (TUG)
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.
Measured: eight weeks
Tetrax((Sunlight Medical Ltd, Israel),Computerized Static Posturography Device
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.
Measured: eight weeks
Secondary outcomes (6)
MS Walking Scale-12(MSWS-12)
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.
Measured: eight weeks
Fatigue Severity Index(FSI)
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.
Measured: eight weeks
Brief International Cognitive Assesment for MS(BICAMS)
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.
Measured: eight weeks
10 Meter Walking Test(10MWT)
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.
Measured: eight weeks
Dual-Task Performance
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.
Measured: eight weeks
Dual-Task Questionnaire(DTQ)
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.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Nov 2022
- Primary completion1 Apr 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ozkeskin, Ege University
- Investigators
- Nur YUCEYAR, MD, Study chair, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526287
- Sponsor's protocol ID
- MOzkeskin
- Status last verified
- Nov 2025
- First submitted
- 29 Jul 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual-Task Training on Balance, Gait, Dual-Task Performance, Cognitive Function, Fatigue in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05526287
- Acronym / sponsor ID
- MOzkeskin
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Balance, Gait, Dual-Task, Cognitive Function, Functional Mobility, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-Task Group | Experimental | Other: Dual-Task TrainingParticipants 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. |
| Control Group | Active comparator | Other: Home Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-Task TrainingDual-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. | Other | Dual-Task Group |
| Home Exercise ProgramHome exercise program includes lower extremity, core stability and balance exercises and will be performed three times a week. | Other | Control Group |
Primary outcome
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.
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.
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.
6 secondary outcomes
MS Walking Scale-12(MSWS-12)
Time frame: eight weeks
Fatigue Severity Index(FSI)
Time frame: eight weeks
Brief International Cognitive Assesment for MS(BICAMS)
Time frame: eight weeks
10 Meter Walking Test(10MWT)
Time frame: eight weeks
Dual-Task Performance
Time frame: eight weeks
Dual-Task Questionnaire(DTQ)
Time frame: eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur YUCEYAR, MD study chair
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Task Training and Home Exercise Program in people with Multiple Sclerosis, run by Ege 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 6 inclusion and 3 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 21 Nov 2025. 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?
Berg Balance Scale(BBS) (time frame: eight weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.