Multiple SclerosisNCT05682963
Efficacy of Square- Stepping Exercises in Individuals With Multiple Sclerosis
A study testing Square Step Exercises Program and Home Exercise Program in people with Multiple Sclerosis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Square stepping exercises can promote correct foot placement, fast and coordinated step patterns, and sensory-motor interaction. The aim of this study is to examine the effect of square stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Square Step Exercises Program and Home Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Nov 2022to 25 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having a disability score of less than 4
- Being between 20-50 years old
- Not having an attack in the last month
- Patients without lower extremity spasticity according to Modified Ashworth Scale (MAS)
Who cannot join
- Having a neurological disease other than Multiple Sclerosis
- Having an Multiple Sclerosis attack during the study
- Having had orthopedic surgery affecting balance
- Presence of cognitive and psychiatric influences that will affect participation in the study
- Having a cardiovascular or pulmonary history that would inhibit participation in the study
- Have received steroid and/or immunosuppressive therapy in the past four weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Denizli Health Services Vocational School of Higher Education
Denizli, Centre, 20160
About this study
Official title: Effect of Square- Stepping Exercises on Mobility, Balance and Knee Joint Position Sense in Individuals With Multiple Sclerosis
Square stepping exercises can promote correct foot placement, fast and coordinated step patterns, and sensory-motor interaction. The aim of this study is to examine the effect of square stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis.
Read the detailed description
Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease of the central nervous system that results in neurological disability. Complex gene-environment interactions play a role in the etiology of multiple sclerosis. Multiple sclerosis is more common in women than men, with a ratio ranging from 2:1 to 3:1.
MS is a very heterogeneous disease and it can have very variable clinical signs and symptoms, including motor, sensory, autonomic and cognitive disorders, depending on the region of the central nervous system. Balance and mobility disorders are the leading symptoms of MS. In addition, somatosensory disorders are frequently encountered as the initial symptom. Disorders in position sense, which is one of the components of somatosensory sense, is an important determinant of limitations during dynamic activities such as walking and balance. In order to reduce disability and improve function in individuals with Multiple Sclerosis, square stepping exercises protocol will be given to one group and a home exercise program protocol to the other group. Created by Shigematsu and Okura to improve balance and reduce the risk of falling, the square stepping exercises is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. There are a number of step patterns that must be followed by the participants. Certain step patterns will be repeated 3-5 times to the participants and the participant will be asked to repeat the same pattern. As a home exercise protocol, a program consisting of frenkel exercises developed by Professor Heinrich Sebastian Frenkel for the treatment of gait, balance and coordination will be applied.
Square stepping exercises can promote correct foot placement, fast and coordinated step patterns, and sensory-motor interaction. The aim of this study is to examine the effect of square stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Square Step Exercises Program, Home Exercise Program
- Keywords
- Multiple Sclerosis, Mobility, Balance, Position Sense
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Square Step Exercises ProgramOther
Intervention description: patient will be treated for eight weeks, two days a week, one session a day, and total 16 session. Each session will be 45 minute.
Home Exercise ProgramOther
Frenkel's coordination exercises will be applied as a home program for 8 weeks, 2 days a week, with each exercise session 15-30 minutes excluding rest periods.
| Study group | Role | What they receive |
|---|---|---|
| Square-Stepping Exercise Program Group | Active comparator | Square stepping exercise is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. Participants practice a set of step patterns on the mat. Square step exercises are a low-cost, highly accessible and fun exercise method. It is known that it improves motor performance and muscle strength in healthy young individuals, and has positive effects on functional fitness and gait parameters in individuals with osteoarthritis. It is known to have positive effects on balance, fall risk, walking ability, physical and cognitive function in elderly individuals. It will be applied to examine the effects on mobility, balance and position sense in individuals with multiple sclerosis. Receives: Other: Square Step Exercises Program |
| Home Exercise Program Group | Active comparator | The home exercise program group will implement a protocol of frenkel's coordination exercises developed for balance and coordination therapy. The exercise protocol, which includes frenkel's coordination exercises, will be delivered to the patient in the form of a brochure and in the form of a Compact Disc (CD) with video images. Receives: Other: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed 25-Foot Walk (T25-FW) Test
With the Timed 25-Foot Walk (T25-FW) Test, the patient's walking speed and lower extremity functions are evaluated. The patient is asked to walk a distance of 7.62 m (25 feet) safely and as quickly as possible. The passing time is recorded in seconds with the chronometer. The T25-FW is the best-defined measurement method for the measurement of gait disturbance in patients with MS and the evaluation of gait speeds of patients with many gait disorders in the clinical setting.
Measured: 8 weeks
Secondary outcomes (5)
Five Times Sit to Stand Test
The patient is asked to sit down and stand up from a standard chair as fast as possible with 5 repetitions. The test starts from a sitting position and ends in a sitting position. The result is recorded in seconds. This method, which is valid and reliable in MS, has been shown to be associated with lower extremity muscle strength and balance. Low times are indicative of high performance.
Measured: 8 week
Four Step Square Test (FSST)
It is a test method used to evaluate the dynamic balance status of individuals. Four squares are formed by placing two canes on a flat surface. All squares are numbered. At the beginning of the test, the patient is told to step into each square as fast as possible, without touching the canes, in consecutive order (2-3-4-1-4-3-2-1). (Requires the patient to step forward, backward, to the right and left side). The time to complete the test is recorded as a score. Low times are indicative of high performance.
Measured: 8 week
Activity-Specific Balance Confidence Scale
It measures the effect of balance disorder on the psychology of the patient. It is a self-report scale in which patients evaluate how confidently they can perform 16 activities that require balance skills, both inside and outside the home, between 0% (unsafe) and 100% (with complete confidence).
Measured: 8 week
Knee Joint Position Sense
The knee joint position sense will be evaluated with the KFORCE Sens® electrogoniometer. For standardization of sensory measurements, the patient is evaluated in a sitting position with the back supported and the hips and knees flexed to 90°. The knee extension angles of 30 and 60 degrees according to the initial position are determined as the target angle, and the repositioning error of the participant is checked. When the participant brings the knee joint to the target angle, the participant is asked to learn the angle by waiting five seconds at this point. Then the knee is brought to the neutral position and the patient is asked to find the target angle. For the target angles, the measurements are repeated three times, the average value is calculated and the reposition error degree of the patients is recorded.
Measured: 8 week
Expanded Disability Status Scale (EDSS)
The EDSS scale is a scale that provides information about the disability status of the patient. Functional systems evaluated by EDSS are pyramidal, cerebral, cerebellar, visual, sensory, brain stem, bladder and bowel functions. Scoring is done between 0 and 10. Scoring between 0 and 3.5 indicates mild disability, scoring between 4.0 and 6.5 indicates moderate disability, and scoring between 7.0 and 10.0 indicates severe disability.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start29 Nov 2022
- Primary completion30 Jun 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Total of two groups: Square stepping exercise program group and home exercise program group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, müge içelli, Pamukkale University
- Investigators
- Müge İçelli, M.Sc., Principal investigator, Pamukkale University Denizli Health Services Vocational School of Higher Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682963
- Sponsor's protocol ID
- PU-FTR-MI-01
- Status last verified
- Jan 2024
- First submitted
- 24 Dec 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunes MI, Akman TC. Effect of square-stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis. Physiother Theory Pract. 2026 Oct 29:1-12. doi: 10.1080/09593985.2026.2727934. Online ahead of print.
PubMed 42954057
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Square- Stepping Exercises on Mobility, Balance and Knee Joint Position Sense in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05682963
- Acronym / sponsor ID
- PU-FTR-MI-01
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Mobility, Balance, Position Sense
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Square stepping exercises can promote correct foot placement, fast and coordinated step patterns, and sensory-motor interaction. The aim of this study is to examine the effect of square stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis.
Detailed description
Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease of the central nervous system that results in neurological disability. Complex gene-environment interactions play a role in the etiology of multiple sclerosis. Multiple sclerosis is more common in women than men, with a ratio ranging from 2:1 to 3:1.
MS is a very heterogeneous disease and it can have very variable clinical signs and symptoms, including motor, sensory, autonomic and cognitive disorders, depending on the region of the central nervous system. Balance and mobility disorders are the leading symptoms of MS. In addition, somatosensory disorders are frequently encountered as the initial symptom. Disorders in position sense, which is one of the components of somatosensory sense, is an important determinant of limitations during dynamic activities such as walking and balance. In order to reduce disability and improve function in individuals with Multiple Sclerosis, square stepping exercises protocol will be given to one group and a home exercise program protocol to the other group. Created by Shigematsu and Okura to improve balance and reduce the risk of falling, the square stepping exercises is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. There are a number of step patterns that must be followed by the participants. Certain step patterns will be repeated 3-5 times to the participants and the participant will be asked to repeat the same pattern. As a home exercise protocol, a program consisting of frenkel exercises developed by Professor Heinrich Sebastian Frenkel for the treatment of gait, balance and coordination will be applied.
Square stepping exercises can promote correct foot placement, fast and coordinated step patterns, and sensory-motor interaction. The aim of this study is to examine the effect of square stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Total of two groups: Square stepping exercise program group and home exercise program group
| Arm | Type | Receives |
|---|---|---|
| Square-Stepping Exercise Program Group | Active comparator | Other: Square Step Exercises ProgramSquare stepping exercise is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. Participants practice a set of step patterns on the mat. Square step exercises are a low-cost, highly accessible and fun exercise method. It is known that it improves motor performance and muscle strength in healthy young individuals, and has positive effects on functional fitness and gait parameters in individuals with osteoarthritis. It is known to have positive effects on balance, fall risk, walking ability, physical and cognitive function in elderly individuals. It will be applied to examine the effects on mobility, balance and position sense in individuals with multiple sclerosis. |
| Home Exercise Program Group | Active comparator | Other: Home Exercise ProgramThe home exercise program group will implement a protocol of frenkel's coordination exercises developed for balance and coordination therapy. The exercise protocol, which includes frenkel's coordination exercises, will be delivered to the patient in the form of a brochure and in the form of a Compact Disc (CD) with video images. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having a disability score of less than 4
- Being between 20-50 years old
- Not having an attack in the last month
- Patients without lower extremity spasticity according to Modified Ashworth Scale (MAS)
Key exclusion criteria (6 listed)
- Having a neurological disease other than Multiple Sclerosis
- Having an Multiple Sclerosis attack during the study
- Having had orthopedic surgery affecting balance
- Presence of cognitive and psychiatric influences that will affect participation in the study
- Having a cardiovascular or pulmonary history that would inhibit participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Square Step Exercises ProgramIntervention description: patient will be treated for eight weeks, two days a week, one session a day, and total 16 session. Each session will be 45 minute. | Other | Square-Stepping Exercise Program Group |
| Home Exercise ProgramFrenkel's coordination exercises will be applied as a home program for 8 weeks, 2 days a week, with each exercise session 15-30 minutes excluding rest periods. | Other | Home Exercise Program Group |
Primary outcome
Timed 25-Foot Walk (T25-FW) Test
Time frame: 8 weeks
With the Timed 25-Foot Walk (T25-FW) Test, the patient's walking speed and lower extremity functions are evaluated. The patient is asked to walk a distance of 7.62 m (25 feet) safely and as quickly as possible. The passing time is recorded in seconds with the chronometer. The T25-FW is the best-defined measurement method for the measurement of gait disturbance in patients with MS and the evaluation of gait speeds of patients with many gait disorders in the clinical setting.
5 secondary outcomes
Five Times Sit to Stand Test
Time frame: 8 week
Four Step Square Test (FSST)
Time frame: 8 week
Activity-Specific Balance Confidence Scale
Time frame: 8 week
Knee Joint Position Sense
Time frame: 8 week
Expanded Disability Status Scale (EDSS)
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Derived from this study: PubMed 42954057Gunes MI, Akman TC. Effect of square-stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis. Physiother Theory Pract. 2026 Oct 29:1-12. doi: 10.1080/09593985.2026.2727934. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Müge İçelli, M.Sc. principal investigator
Pamukkale University Denizli Health Services Vocational School of Higher Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Square Step Exercises Program and Home Exercise Program in people with Multiple Sclerosis, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 25-Foot Walk (T25-FW) Test (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.