- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07461987
Tai Chi and Square-Stepping Exercises in Women With Multiple Sclerosis
The Effects of Tai Chi and Square Stepping Exercises on Joint Position Sense and Clinical Outcomes in Women With Multiple Sclerosis
Study Overview
Status
Conditions
Detailed Description
Multiple Sclerosis (MS) is a chronic and demyelinating disease of the central nervous system observed in young adults. As the disease progresses, impairments occur in motor and sensory functions. Somatosensory inputs, such as knee joint position sense, which is particularly critical for balance and postural control, are frequently affected. In addition to these impairments, a decrease in lower extremity muscle strength and fatigue affecting the vast majority of patients restrict participation in activities of daily living.
Within the scope of this study, women diagnosed with MS will be randomized into one of three different intervention arms: a Tai Chi group incorporating postural stability exercises based on the Yang style; a Square Stepping Exercise (SSE) group consisting of coordinated step patterns aimed at improving sensorimotor integration; or a control group in which Frenkel exercises, representing traditional coordination approaches, are applied. Exercise interventions in all groups were planned for 8 weeks, twice a week.
The study aims to comparatively demonstrate the effects of Tai Chi and Square Stepping Exercises on knee joint position sense, lower extremity muscle strength, and fatigue levels, and to develop evidence-based strategies for these parameters in MS rehabilitation
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Müge İçelli Güneş, PhD
- Phone Number: 02582964256
- Email: micelli@pau.edu.tr
Study Contact Backup
- Name: Tuba Can Akman, Asst. Prof.
- Email: tubacan@pau.edu.tr
Study Locations
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Denizli, Turkey (Türkiye), 20070
- Recruiting
- Department of Neurology, Pamukkale University Hospital
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Contact:
- Müge İçelli Güneş, PhD
- Phone Number: 02582964256
- Email: micelli@pau.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Willing to participate and provide informed consent.
- Diagnosed with multiple sclerosis (MS) according to the McDonald diagnostic criteria.
- Relapsing-remitting MS (RRMS) phenotype.
- EDSS score < 3.5.
- Female, 20-45 years of age.
- No MS relapse within the past 1 month.
- No lower-extremity spasticity according to the Modified Ashworth Scale (MAS).
Exclusion Criteria:
- Any neurological disease other than MS.
- Experiencing an MS relapse during the study period.
- History of orthopedic surgery that may affect balance.
- Cognitive or psychiatric impairment that may interfere with study participation.
- Cardiovascular or pulmonary history that may prevent participation.
- Use of medications that may affect clinical assessment (e.g., antipsychotic use; continuous corticosteroid or immunosuppressive use within the past 1 month).
- Participation in any other exercise program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Tai Chi
Participants in this arm will perform a supervised, group-based Tai Chi program.
The program consists of selected movements from the Yang-style 24-form taught progressively, with emphasis on controlled weight shifting, postural alignment, and coordinated whole-body movement.
Each session includes a warm-up period with general stretching, a main Tai Chi practice component with repeated form practice (with rest breaks as needed), and a cool-down period that includes stretching and controlled breathing techniques.
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Tai Chi will be delivered for 8 weeks, 2 days per week, 1 session per day (total 16 sessions).
Each session will last approximately 45-60 minutes and will include warm-up stretching, main Tai Chi practice, and cool-down stretching plus controlled breathing techniques.
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|
Experimental: Square Stepping Exercise (SSE)
Participants in this arm will receive supervised, group-based Square Stepping Exercise (SSE) performed on a 250 cm × 100 cm mat divided into 40 squares (25 cm each).
Participants will practice predefined stepping patterns that include forward, backward, horizontal (lateral), and diagonal steps.
Selected patterns will be repeated 3-5 times, followed by the mirrored version for the same number of repetitions.
If a participant has difficulty with a pattern, it will be repeated until learned; progression will occur after the participant completes the pattern correctly three consecutive times.
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SSE will be delivered for 8 weeks, 2 days per week, 1 session per day (total 16 sessions).
Each session will be completed in approximately 45-60 minutes, including warm-up and cool-down periods.
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Active Comparator: Home Exercise Program (Frenkel)
Participants in this arm will follow a home-based program consisting of Frenkel Coordination Exercises (FKE), a coordination-focused exercise approach developed to address gait, balance, and coordination.
The exercises emphasize slow, accurate, and well-controlled movements, typically supported by visual guidance and repeated practice to improve movement sequencing and coordination.
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Frenkel Coordination Exercises will be delivered as a home program for 8 weeks, 2 days per week, 1 session per day (total 16 sessions).
Each session will last 15-30 minutes, excluding rest periods.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee joint position sense
Time Frame: Baseline (pre-intervention) and immediately post-intervention (Week 8).
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Knee joint position sense will be assessed using an electrogoniometer.
For standardization, participants will be evaluated in a seated position with back support, with the hip and knee at 90° flexion.
A target angle of 30° knee extension (relative to the start position) will be used.
When the participant reaches the target angle, she will be asked to hold the position for 5 seconds to learn the angle.
The knee will then be returned to the neutral position and the participant will be asked to reproduce the target angle.
Measurements will be repeated three times, the mean value will be calculated, and the absolute error (in degrees) will be recorded.
Assessments will be conducted in a quiet room with eyes closed, with the joint exposed and barefoot.
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Baseline (pre-intervention) and immediately post-intervention (Week 8).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Five-Repetition Sit-to-Stand Test (5STS)
Time Frame: Baseline (pre-intervention) and immediately post-intervention (Week 8).
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Lower-extremity functional strength will be assessed using the Five-Repetition Sit-to-Stand Test (5STS).
Participants will sit on a standard chair and fold their arms across the chest.
They will be instructed (with verbal explanation and practice before testing) to stand up and sit down five times as quickly as possible.
Timing starts from the seated position and ends when the participant returns to the seated position after the 5th repetition.
The result will be recorded in seconds; lower times indicate better performance.
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Baseline (pre-intervention) and immediately post-intervention (Week 8).
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Fatigue Impact Scale (FIS)
Time Frame: Baseline (pre-intervention) and immediately post-intervention (Week 8).
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Fatigue will be assessed using the Fatigue Impact Scale (FIS), which evaluates how fatigued the participant has felt over the past month including the day of assessment.
The scale includes three domains: cognitive (10 items), physical (10 items), and social (20 items).
Each item is rated from 0 to 4 (0 = no problem; 4 = very big problem).
Domain scores are calculated by summing item scores within each domain, and the total score is calculated by summing all domain scores.
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Baseline (pre-intervention) and immediately post-intervention (Week 8).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Müge İçelli Güneş, PhD, Pamukkale University Denizli Health Services Vocational School of Higher Education
Study record dates
Study Major Dates
Study Start (Actual)
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
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Multiple Sclerosis
- Fatigue
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Tai Ji
Other Study ID Numbers
- PU-FTR-MI-03
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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