Multiple SclerosisNCT06949696
Effect of Dual-Task Training and Cognitive Rehabilitation in Individuals With Multiple Sclerosis.
A study testing Dual Task Training, Cognitive Rehabilitation and Conventionel Physiotherapy in people with Multiple Sclerosis, run by Toros University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to examine the effects of dual-task training and cognitive rehabilitation on gait, balance, fatigue and cognitive performance in individuals with multiple sclerosis. 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?
- Dual Task Training, Cognitive Rehabilitation and Conventionel Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Definite MS diagnosis by a neurologist
- Can walk independently
- Expanded Disability Status Scale (EDSS) score below 5
- Has not had an attack in the last 3 months, has been medically stable for 6 months
- Has not received a regular physiotherapy program in the last 6 months volunteer
Who cannot join
- Scoring 26 or below on the Montreal Cognitive Assessment Scale (MoCA)
- Having systemic, orthopedic and neurological problems that may affect walking and balance in the assessments
- Having additional psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aysun Katmerlikaya, MSc contact
Öznur Tunca, MSc contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mersin University
Mersin, 33140
Aysun Katmerlikaya, MSc
Öznur Tunca, Prof. Dr.
About this study
Official title: Effects of Dual-Task Training and Cognitive Rehabilitation on Gait, Balance, Fatigue and Cognitive Performance in Individuals With Multiple Sclerosis
The purpose of this study is to examine the effects of dual-task training and cognitive rehabilitation on gait, balance, fatigue and cognitive performance in individuals with multiple sclerosis.
Read the detailed description
Multiple sclerosis (MS) is a complex disease characterized by chronic, inflammatory, demyelinating and neurodegenerative processes of the central nervous system (CNS) with heterogeneous clinical symptoms. Balance, gait and cognitive impairment are among the biggest problems in individuals with MS and significantly affect their daily lives.
Dual Task (DT); is the process of performing two tasks that can be performed independently and have different purposes simultaneously. Walking with dual tasks has recently been shown to resemble typical walking performance in daily life, thus providing clinicians with a realistic walking performance measurement in daily life. Although the effects of dual task performance in various neurological diseases have been partially described in the literature, the comparison of dual task training and cognitive rehabilitation on walking, balance, fatigue and cognitive performance has not been made and due to this deficiency in the literature, our study was planned and has originality. The aim of our study is to investigate the effects of dual task training and cognitive rehabilitation on walking, balance, fatigue and cognitive performance in individuals with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Dual Task Training, Cognitive Rehabilitation, Conventionel Physiotherapy
- Keywords
- multiple sclerosis, balance, gait, dual task, fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Task TrainingOther
In dual task training, patients will be given cognitive exercises such as counting backwards from 100 by 3, counting the names of cities, girls and boys while walking.
Cognitive RehabilitationOther
In cognitive rehabilitation, patients will be given paper-and-pencil activities and exercises to find the difference between two pictures.
Conventionel PhysiotherapyOther
In conventionel physiotherapy, patients will be given posture exercises for balance and strengthening.
| Study group | Role | What they receive |
|---|---|---|
| Dual Task Training Group | Experimental | The dual task training group will receive training 2 days a week for 6 weeks. Patients will receive dual task training. They will also receive 30 minutes of individual physiotherapy exercises. 2 days a week. The effects of dual task training and cognitive rehabilitation on gait, balance, fatigue and cognitive performance will be compared. Receives: Other: Dual Task Training |
| Cognitive Rehabilitation Group | Experimental | The cognitive rehabilitation group will receive training 2 days a week for 6 weeks. Patients will receive cognitive rehabilitation group. They will also receive 30 minutes of individual physiotherapy exercises 2 days a week. Receives: Other: Cognitive Rehabilitation |
| Conventionel Physiotherapy Group | Active comparator | The conventionel physiotherapy group will receive training 2 days a week for 6 weeks.This group will only receive individual physiotherapy 2 days a week. Receives: Other: Conventionel Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index (DGI)
DGI is a test that measures the capacity to adapt to changes in walking.It evaluates a total of 8 parameters over 24 points. Values of 19 points and below define the presence of a fall risk.
Measured: a year
Secondary outcomes (5)
Timed 25 Food Walk Test (T25FWT)
Timed 25 Food Walk Test is a test that evaluates walking speed. In the test, the patient is asked to walk 25 steps as quickly and safely as possible and the time is recorded in seconds with the average of 2 trials.
Measured: a year
The 12-item MS Walking Scale (12-MSWS)
The 12-item MS Walking Scale (12-MSWS) that evaluates walking ability over the last 2 weeks, scaled from 0 to 100.
Measured: a year
BICAMS (Brief International Cognitive Assessment for MS)
BICAMS (Brief International Cognitive Assessment for MS) is an international initiative to recommend and support a cognitive assessment that is brief, practical and universal.
Measured: a year
Trial Making Test (TMT)
Trial Making Test (TMT)is used to evaluate individuals' executive functions, visual-motor perception, visual scanning and attention speed, motor function, organization, and planning.
Measured: a year
Modified Fatigue Impact Scale (MFIS)
It is a multidimensional self-report questionnaire consisting of 21 questions in total, which is frequently used in individuals with MS and evaluates subjective fatigue physically (9 items), cognitively (10 items) and psychosocially (2 items).
Measured: a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start20 Apr 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Model description
- Comparison of 3 different physiotherapy groups(dual task training group, cognitive rehabilitation group, conventional physical therapy group)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysun Katmerlikaya, Toros University
- Investigators
- Aysun Katmerlikaya, MSc, Principal investigator, Toros UniversityÖznur Tunca, Prof.Dr., Study director, Hacettepe UniversitySerhan Sevim, Prof.Dr., Study chair, Mersin UniversityYeliz Salcı, Assoc.Prof., Study chair, Hacettepe UniversityDilek Hande Esen, PhD, Study chair, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949696
- Sponsor's protocol ID
- TU-FTR-AK-01
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozkul C, Guclu-Gunduz A, Eldemir K, Apaydin Y, Gulsen C, Yazici G, Soke F, Irkec C. Dual-Task Cost and Related Clinical Features in Patients With Multiple Sclerosis. Motor Control. 2021 Jan 12;25(2):211-233. doi: 10.1123/mc.2020-0035.
PubMed 33440347Abasiyanik Z, Kahraman T. Effect of dual-task training on cognitive functions in persons with multiple sclerosis: A systematic review and meta-analysis. Mult Scler Relat Disord. 2022 Jun;62:103801. doi: 10.1016/j.msard.2022.103801. Epub 2022 Apr 10.
PubMed 35430546
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual-Task Training and Cognitive Rehabilitation on Gait, Balance, Fatigue and Cognitive Performance in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06949696
- Acronym / sponsor ID
- TU-FTR-AK-01
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, balance, gait, dual task, fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 29 Apr 2025 (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 examine the effects of dual-task training and cognitive rehabilitation on gait, balance, fatigue and cognitive performance in individuals with multiple sclerosis.
Detailed description
Multiple sclerosis (MS) is a complex disease characterized by chronic, inflammatory, demyelinating and neurodegenerative processes of the central nervous system (CNS) with heterogeneous clinical symptoms. Balance, gait and cognitive impairment are among the biggest problems in individuals with MS and significantly affect their daily lives.
Dual Task (DT); is the process of performing two tasks that can be performed independently and have different purposes simultaneously. Walking with dual tasks has recently been shown to resemble typical walking performance in daily life, thus providing clinicians with a realistic walking performance measurement in daily life. Although the effects of dual task performance in various neurological diseases have been partially described in the literature, the comparison of dual task training and cognitive rehabilitation on walking, balance, fatigue and cognitive performance has not been made and due to this deficiency in the literature, our study was planned and has originality. The aim of our study is to investigate the effects of dual task training and cognitive rehabilitation on walking, balance, fatigue and cognitive performance in individuals with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Comparison of 3 different physiotherapy groups(dual task training group, cognitive rehabilitation group, conventional physical therapy group)
| Arm | Type | Receives |
|---|---|---|
| Dual Task Training Group | Experimental | Other: Dual Task TrainingThe dual task training group will receive training 2 days a week for 6 weeks. Patients will receive dual task training. They will also receive 30 minutes of individual physiotherapy exercises. 2 days a week. The effects of dual task training and cognitive rehabilitation on gait, balance, fatigue and cognitive performance will be compared. |
| Cognitive Rehabilitation Group | Experimental | Other: Cognitive RehabilitationThe cognitive rehabilitation group will receive training 2 days a week for 6 weeks. Patients will receive cognitive rehabilitation group. They will also receive 30 minutes of individual physiotherapy exercises 2 days a week. |
| Conventionel Physiotherapy Group | Active comparator | Other: Conventionel PhysiotherapyThe conventionel physiotherapy group will receive training 2 days a week for 6 weeks.This group will only receive individual physiotherapy 2 days a week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Definite MS diagnosis by a neurologist
- Can walk independently
- Expanded Disability Status Scale (EDSS) score below 5
- Has not had an attack in the last 3 months, has been medically stable for 6 months
- Has not received a regular physiotherapy program in the last 6 months volunteer
Key exclusion criteria (3 listed)
- Scoring 26 or below on the Montreal Cognitive Assessment Scale (MoCA)
- Having systemic, orthopedic and neurological problems that may affect walking and balance in the assessments
- Having additional psychiatric disorders
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 TrainingIn dual task training, patients will be given cognitive exercises such as counting backwards from 100 by 3, counting the names of cities, girls and boys while walking. | Other | Dual Task Training Group |
| Cognitive RehabilitationIn cognitive rehabilitation, patients will be given paper-and-pencil activities and exercises to find the difference between two pictures. | Other | Cognitive Rehabilitation Group |
| Conventionel PhysiotherapyIn conventionel physiotherapy, patients will be given posture exercises for balance and strengthening. | Other | Conventionel Physiotherapy Group |
Primary outcome
Dynamic Gait Index (DGI)
Time frame: a year
DGI is a test that measures the capacity to adapt to changes in walking.It evaluates a total of 8 parameters over 24 points. Values of 19 points and below define the presence of a fall risk.
5 secondary outcomes
Timed 25 Food Walk Test (T25FWT)
Time frame: a year
The 12-item MS Walking Scale (12-MSWS)
Time frame: a year
BICAMS (Brief International Cognitive Assessment for MS)
Time frame: a year
Trial Making Test (TMT)
Time frame: a year
Modified Fatigue Impact Scale (MFIS)
Time frame: a year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Background: PubMed 33440347Ozkul C, Guclu-Gunduz A, Eldemir K, Apaydin Y, Gulsen C, Yazici G, Soke F, Irkec C. Dual-Task Cost and Related Clinical Features in Patients With Multiple Sclerosis. Motor Control. 2021 Jan 12;25(2):211-233. doi: 10.1123/mc.2020-0035.
- Results publication: PubMed 35430546Abasiyanik Z, Kahraman T. Effect of dual-task training on cognitive functions in persons with multiple sclerosis: A systematic review and meta-analysis. Mult Scler Relat Disord. 2022 Jun;62:103801. doi: 10.1016/j.msard.2022.103801. Epub 2022 Apr 10.
- Effect of dual-task training on cognitive functions in persons with multiple sclerosis: A systematic review and meta-analysisLink provided by the sponsor.
- Dual-Task Cost and Related Clinical Features in Patients With Multiple SclerosisLink provided by the sponsor.
- 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.
Aysun Katmerlikaya, MSc contact
Öznur Tunca, MSc contact
Aysun Katmerlikaya, MSc principal investigator
Toros University
Öznur Tunca, Prof.Dr. study director
Hacettepe University
Serhan Sevim, Prof.Dr. study chair
Mersin 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, Cognitive Rehabilitation and Conventionel Physiotherapy in people with Multiple Sclerosis, run by Toros 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 5 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: looking for participants now, as of the sponsor's last update on 29 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aysun Katmerlikaya, MSc (aysun.katmerlikaya@toros.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Gait Index (DGI) (time frame: a year). 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 NCT06949696, which also lists 2 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 29 Apr 2025.