Multiple SclerosisNCT05433714
Figure of 8 Walk Test in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Assesment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 6 Oct 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Multiple Sclerosis Patients
Who may be able to join
- Having an EDSS score of 4 and below,
- Being between the ages of 18-65
- Willingness to participate in the study
Who cannot join
- Being pregnant or within the first 3 months after giving birth,
- Receiving corticosteroid therapy in the last 1 month,
- Using drugs that will affect walking in the last 1 month
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sutcu Imam University
Kahramanmaraş
About this study
Official title: The Reliability and Validity of the Figure of 8 Walk Test in Multiple Sclerosis
Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Given the prevalence and clinical significance of balance dysfunction in individuals with MS, the assessment of balance has become an important focus in MS clinical practice and research. The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking performance required in daily life. Beyond walking straight, turning ability is required in many situations in daily life such as walking around a table, avoiding obstacles and navigating the street. The gait characteristics of walking on a straight and curved road are different. During curved walking, the center of mass of the body shifts to the inner leg as the stance time of the inner leg increases, as opposed to walking on a straight track. Compared to other standardized tests, scoring is not dependent on the subjectivity of the examiner, can be administered by a person with minimal training, and requires minimal time, space, and equipment. The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices.
Read the detailed description
Multiple sclerosis (MS) is a progressive disease of the central nervous system characterized by demyelination and destruction of motor and sensory axons. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. The prevalence of balance dysfunction in individuals with MS and Given its clinical relevance, the assessment of balance has become an important focus in MS clinical practice and research. The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking performance required in daily life.In the figure of 8 walk test, two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. The elapsed time is recorded.
The aim of the study is to examine the validity and reliability of the 8-shape walking test in MS patients.
- Conditions
- Multiple Sclerosis
- Being tested
- Assesment
- Keywords
- multiple scleorsis, balance, Walking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssesmentOther
The figure of walk test, Berg Balance scale, Timed 25-Foot Walk, Timed up and go test, Foursquare walk test
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis patient | First day, first evaluator will perform all tests, and second day, second evaluator will perform the figure of 8 walk test. Receives: Other: Assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Figure of Walk Test
Two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. Elapsed time is recorded
Measured: First day
The Figure of Walk Test
Two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. Elapsed time is recorded
Measured: second day
Secondary outcomes (4)
Berg Balance scale
It is a 14-item scale that measures the ability to maintain balance while performing functional tasks. Each item is scored between 0 and 4. Balance is considered good if the total score is 45 and above.
Measured: First day
Timed up and go test
At the beginning of the test, individuals sit in a chair. A distance of 3 m is set in front of it. With the start command, he gets up from his seat and walks 3 m, turns around and walks back and sits. With the start command, the time to sit on the chair is recorded in seconds. Short duration indicates good functional mobility.
Measured: First day
Timed 25-Foot Walk test
It is an evaluation to evaluate mobility and leg functions. Individuals are asked to safely walk 7.62 m on a flat surface at their highest speed.
Measured: First day
Four Square Step Test
It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided into 4 equal parts. The number 1 is written in the lower right corner, up to 4 clockwise. With the start command, individuals are asked to step on the numbers in order.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Aug 2022
- Primary completion1 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University
- Investigators
- Zekiye İpek Katırcı Kırmacı, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433714
- Sponsor's protocol ID
- ipekkrmc
- Status last verified
- Oct 2022
- First submitted
- 21 Jun 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the Figure of 8 Walk Test in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05433714
- Acronym / sponsor ID
- ipekkrmc
- Conditions
- Multiple Sclerosis
- Keywords
- multiple scleorsis, balance, Walking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 27 Jun 2022 (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.
Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Given the prevalence and clinical significance of balance dysfunction in individuals with MS, the assessment of balance has become an important focus in MS clinical practice and research. The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking performance required in daily life. Beyond walking straight, turning ability is required in many situations in daily life such as walking around a table, avoiding obstacles and navigating the street. The gait characteristics of walking on a straight and curved road are different. During curved walking, the center of mass of the body shifts to the inner leg as the stance time of the inner leg increases, as opposed to walking on a straight track. Compared to other standardized tests, scoring is not dependent on the subjectivity of the examiner, can be administered by a person with minimal training, and requires minimal time, space, and equipment. The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices.
Detailed description
Multiple sclerosis (MS) is a progressive disease of the central nervous system characterized by demyelination and destruction of motor and sensory axons. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. The prevalence of balance dysfunction in individuals with MS and Given its clinical relevance, the assessment of balance has become an important focus in MS clinical practice and research. The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking performance required in daily life.In the figure of 8 walk test, two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. The elapsed time is recorded.
The aim of the study is to examine the validity and reliability of the 8-shape walking test in MS patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patient | – | Other: AssesmentFirst day, first evaluator will perform all tests, and second day, second evaluator will perform the figure of 8 walk test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Sclerosis Patients
Key inclusion criteria (3 listed)
- Having an EDSS score of 4 and below,
- Being between the ages of 18-65
- Willingness to participate in the study
Key exclusion criteria (3 listed)
- Being pregnant or within the first 3 months after giving birth,
- Receiving corticosteroid therapy in the last 1 month,
- Using drugs that will affect walking in the last 1 month
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 |
|---|---|---|
| AssesmentThe figure of walk test, Berg Balance scale, Timed 25-Foot Walk, Timed up and go test, Foursquare walk test | Other | Multiple sclerosis patient |
Primary outcome
The Figure of Walk Test
Time frame: First day
Two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. Elapsed time is recorded
The Figure of Walk Test
Time frame: second day
Two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. Elapsed time is recorded
4 secondary outcomes
Berg Balance scale
Time frame: First day
Timed up and go test
Time frame: First day
Timed 25-Foot Walk test
Time frame: First day
Four Square Step Test
Time frame: First day
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 10 Oct 2022.
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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.
Zekiye İpek Katırcı Kırmacı principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Kahramanmaras Sutcu Imam 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 3 inclusion and 3 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 10 Oct 2022. 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?
The Figure of Walk Test (time frame: First day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2022.