Clinical trial NCT06949696: Effect of Dual-Task Training and Cognitive Rehabilitation in Individuals With Multiple Sclerosis.
Official title: Effects of Dual-Task Training and Cognitive Rehabilitation on Gait, Balance, Fatigue and Cognitive Performance in Individuals With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
balance
gait
dual task
fatigue
Lead sponsor: Toros University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of 3 different physiotherapy groups(dual task training group, cognitive rehabilitation group, conventional physical therapy group)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dynamic Gait Index (DGI)
timeFrame: a year
Secondary outcomes:
measure: Timed 25 Food Walk Test (T25FWT)
timeFrame: a year
measure: The 12-item MS Walking Scale (12-MSWS)
timeFrame: a year
measure: BICAMS (Brief International Cognitive Assessment for MS)
timeFrame: a year
measure: Trial Making Test (TMT)
timeFrame: a year
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: a year
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
affiliation: Toros University
name: Aysun Katmerlikaya, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Öznur Tunca, Prof.Dr.
role: STUDY_DIRECTOR
affiliation: Mersin University
name: Serhan Sevim, Prof.Dr.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Yeliz Salcı, Assoc.Prof.
role: STUDY_CHAIR
affiliation: Toros University
name: Dilek Hande Esen, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.