NCT06949696

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
1mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Apr 2025Jun 2026

Study Start

First participant enrolled

April 20, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 22, 2025

Last Update Submit

April 22, 2025

Conditions

Keywords

multiple sclerosisbalancegaitdual taskfatigue

Outcome Measures

Primary Outcomes (1)

  • 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.

    a year

Secondary Outcomes (5)

  • Timed 25 Food Walk Test (T25FWT)

    a year

  • The 12-item MS Walking Scale (12-MSWS)

    a year

  • BICAMS (Brief International Cognitive Assessment for MS)

    a year

  • Trial Making Test (TMT)

    a year

  • Modified Fatigue Impact Scale (MFIS)

    a year

Study Arms (3)

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.

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.

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.

Other: Conventionel Physiotherapy

Interventions

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.

Dual Task Training Group

In cognitive rehabilitation, patients will be given paper-and-pencil activities and exercises to find the difference between two pictures.

Cognitive Rehabilitation Group

In conventionel physiotherapy, patients will be given posture exercises for balance and strengthening.

Conventionel Physiotherapy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, 33140, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33440347BACKGROUND
  • Abasiyanik 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.

Related Links

MeSH Terms

Conditions

Multiple SclerosisFatigue

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Aysun Katmerlikaya, MSc

    Toros University

    PRINCIPAL INVESTIGATOR
  • Öznur Tunca, Prof.Dr.

    Hacettepe University

    STUDY DIRECTOR
  • Serhan Sevim, Prof.Dr.

    Mersin University

    STUDY CHAIR
  • Yeliz Salcı, Assoc.Prof.

    Hacettepe University

    STUDY CHAIR
  • Dilek Hande Esen, PhD

    Toros University

    STUDY CHAIR

Central Study Contacts

Aysun Katmerlikaya, MSc

CONTACT

Öznur Tunca, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A randomized, single-blind, controlled trial comparing a dual-task training group, a cognitive rehabilitation group, and a conventional physical therapy group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison of 3 different physiotherapy groups(dual task training group, cognitive rehabilitation group, conventional physical therapy group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 22, 2025

First Posted

April 29, 2025

Study Start

April 20, 2025

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations