- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: İsmail Okur, Assistant professor with a Ph.
- Phone Number: +90 (555) 243 67 26
- Email: ismail.okur@ksbu.edu.tr
Study Locations
-
-
Merkez
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Kütahya, Merkez, Turkey (Türkiye), 43000
- Recruiting
- Kütahya Sağlık Bilimleri Üniversitesi, Sağlıklı Yaşam Fizyoterapi ve Rehabilitasyon Merkezi
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Contact:
- Sağlıklı Yaşam Fizyoterapi Merkezi Sağlıklı Yaşam Fizyoterapi Merkezi
- Phone Number: 1499 0274 260b 0043
- Email: safir@ksbu.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Internal Focus Training
Participants receive dual-task exercise training with internal focus instructions.
|
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.
|
|
Experimental: External Focus Training
Participants receive dual-task exercise training with external focus instructions directed toward movement effects or external targets.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and after 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and after 8 weeks
|
|
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.
|
Baseline and after 8 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSU-MS-DT-RCT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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-
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-
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