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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

30

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Toros University

Investigators

  • 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)

April 20, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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