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NCT Number: NCT07507084

The Effect of Internal- or External-Focused Exercise Training, Administered in Conjunction With a Cognitive Task, on Walking, Balance, and Cognitive Functions in Individuals With Multiple Sclerosis

This interventional clinical trial aims to investigate the effects of internal and external focus-based exercise training combined with cognitive dual-task training in individuals diagnosed with multiple sclerosis. The primary objective is to determine whether these exercise approaches improve gait, balance, and cognitive functions.

The main research questions are:

Does dual-task training combined with internal focus-based exercises improve gait, balance, and cognitive performance? Does dual-task training combined with external focus-based exercises lead to greater improvements compared to internal focus strategies?

Participants will be divided into two groups, and the researchers will compare the effects of internal focus-based and external focus-based dual-task exercise training on functional outcomes.

Participants will:

Perform structured exercise sessions under the supervision of a physiotherapist Engage in dual-task activities by combining motor exercises with simple cognitive tasks (e.g., backward counting, word generation) Participate in an 8-week training program, with sessions held twice a week lasting approximately 45-60 minutes Undergo assessments of gait, balance, and cognitive function before and after the intervention

This study does not involve invasive procedures or biological sample collection. The findings are expected to contribute to the development of more effective dual-task rehabilitation strategies for individuals with multiple sclerosis.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kütahya Sağlık Bilimleri Üniversitesi, Sağlıklı Yaşam Fizyoterapi ve Rehabilitasyon Merkezi

Kütahya, Merkez, 43000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sağlıklı Yaşam Fizyoterapi Merkezi Sağlıklı Yaşam Fizyoterapi Merkezi

CONTACT

[email protected]

0274 260b 0043 ext. 1499

About this study

Multiple sclerosis (MS) is a chronic neurological disease characterized by motor and cognitive impairments that significantly affect functional mobility and independence. Dual-task performance, which requires the simultaneous execution of motor and cognitive tasks, is frequently impaired in individuals with MS and has been associated with decreased gait performance, balance deficits, and increased risk of falls.

In recent years, dual-task training has emerged as an effective rehabilitation approach to improve functional performance in neurological populations. In addition, attentional focus strategies, including internal focus (focusing on body movements) and external focus (focusing on movement outcomes), have been shown to influence motor learning and performance. However, the comparative effects of internal and external focus strategies when combined with dual-task training in individuals with MS remain unclear.

This study is designed as an interventional clinical trial to investigate the effects of dual-task training combined with internal and external focus-based exercise approaches on gait, balance, and cognitive functions in individuals with MS. Participants will be allocated into two groups receiving either internal focus-based or external focus-based dual-task training.

The intervention program will be conducted over an 8-week period under the supervision of a physiotherapist. Outcome measures will include assessments of gait performance, balance, and cognitive function before and after the intervention. The results of this study are expected to provide evidence for optimizing dual-task rehabilitation strategies and improving functional outcomes in individuals with MS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Multiple Sclerosis according to the revised McDonald criteria
  • Aged between 20 and 60 years
  • Ability to understand and follow simple instructions
  • Ability to stand and walk independently or with an assistive device
  • Ability to speak and understand Turkish
  • Score of ≥21 on the Montreal Cognitive Assessment (MoCA)
  • Willingness to participate in the study

Exclusion criteria

  • MS relapse within the last 30 days
  • Presence of any other neurological disease besides Multiple Sclerosis
  • Any musculoskeletal condition that may affect walking or balance
  • History of uncontrolled cardiorespiratory conditions within the last 3 months (e.g., hypertension, arrhythmia, tachycardia, or acute cardiopulmonary events)
  • Severe visual or hearing impairment

Treatment and study plan

Internal Focus Dual-Task Training

Behavioral

Participants perform dual-task exercise training with instructions focusing on their own body movements during task execution. The program includes gait, balance, and cognitive tasks.

External Focus Dual-Task Training

Behavioral

Participants receive dual-task exercise training with external focus instructions directed to movement effects or external targets. The program includes gait, balance, and cognitive tasks performed simultaneously.

Primary outcomes

  1. Gait Performance Under Dual-Task Conditions

    Time frame: Baseline and after 8 weeks

    Gait performance will be assessed using the Zebris FDM System (FDM 1.5). Parameters will include step length, stride length, step width, step time, stride time, cadence, gait speed, stance phase percentage, swing phase percentage, and double support phase percentage under dual-task conditions.

Secondary outcomes

  1. Cognitive Function (BICAMS)

    Time frame: Baseline and after 8 weeks

    Cognitive function will be assessed using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), including the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test (CVLT), and Brief Visuospatial Memory Test (BVMT). Assessments will be conducted by a clinical psychologist.

  2. Balance Performance

    Time frame: Baseline and after 8 weeks

    Balance will be assessed using the Zebris FDM System (FDM 1.5). Parameters will include center of pressure (COP) path length, COP velocity, and forefoot and rearfoot load distribution percentages.

Study contacts

Contact information is provided by the study sponsor or research team.

İsmail Okur, Assistant professor with a Ph.

CONTACT

[email protected]

+90 (555) 243 67 26

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 2, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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