Effect of Dual-Task Training and Cognitive Rehabilitation in Individuals With Multiple Sclerosis.

April 22, 2025 updated by: Aysun Katmerlikaya, Toros University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Öznur Tunca, MSc
  • Phone Number: 03123051080

Study Locations

  • Turkey
      • Mersin, Turkey, 33140
        • Recruiting
        • Mersin University
        • Contact:
          • Aysun Katmerlikaya, MSc
        • Contact:
          • Öznur Tunca, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dual Task Training Group
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.
Other: Dual Task Training
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.
Experimental: Cognitive Rehabilitation Group
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.
Other: Cognitive Rehabilitation
In cognitive rehabilitation, patients will be given paper-and-pencil activities and exercises to find the difference between two pictures.
Active Comparator: Conventionel Physiotherapy Group
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.
Other: Conventionel Physiotherapy
In conventionel physiotherapy, patients will be given posture exercises for balance and strengthening.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
a year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timed 25 Food Walk Test (T25FWT)
Time Frame: a year
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.
a year
The 12-item MS Walking Scale (12-MSWS)
Time Frame: a year
The 12-item MS Walking Scale (12-MSWS) that evaluates walking ability over the last 2 weeks, scaled from 0 to 100.
a year
BICAMS (Brief International Cognitive Assessment for MS)
Time Frame: a year
BICAMS (Brief International Cognitive Assessment for MS) is an international initiative to recommend and support a cognitive assessment that is brief, practical and universal.
a year
Trial Making Test (TMT)
Time Frame: a year
Trial Making Test (TMT)is used to evaluate individuals' executive functions, visual-motor perception, visual scanning and attention speed, motor function, organization, and planning.
a year
Modified Fatigue Impact Scale (MFIS)
Time Frame: a year
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).
a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Toros University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aysun Katmerlikaya, MSc, Toros University
  • Study Director: Öznur Tunca, Prof.Dr., Hacettepe University
  • Study Chair: Serhan Sevim, Prof.Dr., Mersin University
  • Study Chair: Yeliz Salcı, Assoc.Prof., Hacettepe University
  • Study Chair: Dilek Hande Esen, PhD, Toros University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TU-FTR-AK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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