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

NCT07507084 | Recruiting

• 1 other identifier: KSU-MS-DT-RCT-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, dual-task training, internal focus, external focus, gait, balance, cognitive function, exercise therapy

Outcome Measures

Primary Outcomes (1)

• Gait Performance Under Dual-Task Conditions

  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.

  Baseline and after 8 weeks

Secondary Outcomes (2)

• Cognitive Function (BICAMS)

  Baseline and after 8 weeks

• Balance Performance

  Baseline and after 8 weeks

Study Arms (2)

Internal Focus Training

EXPERIMENTAL

Participants receive dual-task exercise training with internal focus instructions.

Behavioral: Internal Focus Dual-Task Training

External Focus Training

EXPERIMENTAL

Participants receive dual-task exercise training with external focus instructions directed toward movement effects or external targets.

Behavioral: External Focus Dual-Task Training

Interventions

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.

Internal Focus Training

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.

External Focus Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Sağlık Bilimleri Üniversitesi, Sağlıklı Yaşam Fizyoterapi ve Rehabilitasyon Merkezi

Kütahya, Merkez, 43000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

İsmail Okur, Assistant professor with a Ph.

CONTACT

+90 (555) 243 67 26; ismail.okur@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Ph.D.

Model Details: Participants will be randomly assigned to either the internal focus or external focus dual-task training groups. Both groups will receive structured exercise programs under dual-task conditions. Outcomes related to gait, balance, and cognitive function will be assessed at baseline and post-intervention.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 30, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)