Multiple Sclerosis, Relapsing-RemittingNCT03718026
The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate reliability, validity, and responsiveness of the timed 360° turn test in patients with Multiple Sclerosis. 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, Relapsing-Remitting
- What is being tested?
- The timed 360° turn test
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2018to 19 Nov 2018
- 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: Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Who may be able to join
- at least 18 years,
- neurologist-diagnosed Multiple Sclerosis,
- Expanded Disability Status Scale (EDSS) score < 7,
- able to walk 20 m with or without aids,
- no MS exacerbation within the last 2 months,
- use of stable medication in the last 2 months.
Who cannot join
- other neurologic disorder,
- Pregnancy,
- orhopedic problems affecting gait and stance,
- visual, auditory, orientational problems that could affect study results,
- Cardiovascular, pulmonary, and humoral disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test Test in Patients With Multiple Sclerosis
The aim of the study is to investigate reliability, validity, and responsiveness of the timed 360° turn test in patients with Multiple Sclerosis.
Read the detailed description
At baseline, the timed 360° turn test, Berg Balance Scale, Timed Up and Go test, Functional Reach Test, Four Square Step Test, and One-legged Stance Test is applied to the Multiple Sclerosis group. The timed 360° turn test is repeated after seven days from the first application in patients with Multiple Sclerosis. Healthy controls are going to perform only the timed 360° turn test.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- The timed 360° turn test
- Keywords
- The timed 360° turn test, Multiple sclerosis, reliability, validity
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The timed 360° turn testOther
Also called Berg Balance Scale, Timed Up and Go test, Functional Reach Test, One-leg stance test, Four square step test
- The timed 360° turn test: Each participant turns around in place in a standing position for both sides.
- Berg Balance Scale: It has 14 items, each of which is scored from 0 (i.e, severely impaired balance) to 4 (i.e., no balance impairment).
- Timed Up and Go test: It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again.
- Functional Reach Test: It measures the maximum distance an individual is able to reach forward beyond arm's length in the standing position when maintaining a fixed base of support.
- One-leg stance test: Individuals were asked to stand on either their left or right leg.
- Four square step test: It requires an individual to step over obstacles in various directions including forward, backward, and sideways.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis | * The timed 360° turn test
* Berg Balance Scale
* Timed Up and Go test
* Functional Reach Test
* One-leg stance test
* Four square step test Receives: Other: The timed 360° turn test | |
| Healthy Controls | -The timed 360° turn test Receives: Other: The timed 360° turn test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The timed 360° turn test
The timed 360° turn test evaluates turning ability. Higher durations indicate worse turning performance.
Measured: 1 minute
Secondary outcomes (5)
Berg Balance Scale
Berg Balance Scale assesses functional balance. It consists of 14 functional tasks rated on a 5-point scale ranging from 0 to 4. The maximum score is 56 points. Higher scores indicate better functional balance.
Measured: 10 minutes
Timed Up and Go test
Timed Up and Go test evaluates functional mobility. Higher durations indicate worse functional mobility.
Measured: 1 minute
Functional Reach Test
Functional Reach Test is used to evaluate limits of stability. Higher distances indicate better limits of stability.
Measured: 1 minute
Four Square Step Test
Four Square Step Test is used to assess dynamic balance. Higher durations indicate worse dynamic balance.
Measured: 1 minute
One Leg Stance Test
One Leg Stance Test evaluates postural stability. Higher durations indicate better postural stability.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start24 Oct 2018
- Primary completion16 Nov 2018
- Study completion19 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Söke, Gazi University
- Investigators
- Fatih Söke, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718026
- Sponsor's protocol ID
- 438
- Status last verified
- Nov 2018
- First submitted
- 22 Oct 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Adusumilli G, Lancia S, Levasseur VA, Amblee V, Orchard M, Wagner JM, Naismith RT. Turning is an important marker of balance confidence and walking limitation in persons with multiple sclerosis. PLoS One. 2018 Jun 7;13(6):e0198178. doi: 10.1371/journal.pone.0198178. eCollection 2018.
PubMed 29879144Spain RI, St George RJ, Salarian A, Mancini M, Wagner JM, Horak FB, Bourdette D. Body-worn motion sensors detect balance and gait deficits in people with multiple sclerosis who have normal walking speed. Gait Posture. 2012 Apr;35(4):573-8. doi: 10.1016/j.gaitpost.2011.11.026. Epub 2012 Jan 25.
PubMed 22277368Gunn H, Creanor S, Haas B, Marsden J, Freeman J. Frequency, characteristics, and consequences of falls in multiple sclerosis: findings from a cohort study. Arch Phys Med Rehabil. 2014 Mar;95(3):538-45. doi: 10.1016/j.apmr.2013.08.244. Epub 2013 Sep 18.
PubMed 24055784Cameron MH, Asano M, Bourdette D, Finlayson ML. People with multiple sclerosis use many fall prevention strategies but still fall frequently. Arch Phys Med Rehabil. 2013 Aug;94(8):1562-6. doi: 10.1016/j.apmr.2013.01.021. Epub 2013 Feb 4.
PubMed 23391522
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test Test in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03718026
- Acronym / sponsor ID
- 438
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- The timed 360° turn test, Multiple sclerosis, reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 24 Oct 2018 (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.
The aim of the study is to investigate reliability, validity, and responsiveness of the timed 360° turn test in patients with Multiple Sclerosis.
Detailed description
At baseline, the timed 360° turn test, Berg Balance Scale, Timed Up and Go test, Functional Reach Test, Four Square Step Test, and One-legged Stance Test is applied to the Multiple Sclerosis group. The timed 360° turn test is repeated after seven days from the first application in patients with Multiple Sclerosis. Healthy controls are going to perform only the timed 360° turn test.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis | – | Other: The timed 360° turn test* The timed 360° turn test * Berg Balance Scale * Timed Up and Go test * Functional Reach Test * One-leg stance test * Four square step test |
| Healthy Controls | – | Other: The timed 360° turn test-The timed 360° turn test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Key inclusion criteria (6 listed)
- at least 18 years,
- neurologist-diagnosed Multiple Sclerosis,
- Expanded Disability Status Scale (EDSS) score < 7,
- able to walk 20 m with or without aids,
- no MS exacerbation within the last 2 months,
Key exclusion criteria (5 listed)
- other neurologic disorder,
- Pregnancy,
- orhopedic problems affecting gait and stance,
- visual, auditory, orientational problems that could affect study results,
- Cardiovascular, pulmonary, and humoral disease.
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 |
|---|---|---|
| The timed 360° turn testAlso: Berg Balance Scale, Timed Up and Go test, Functional Reach Test, One-leg stance test, Four square step test* The timed 360° turn test: Each participant turns around in place in a standing position for both sides. * Berg Balance Scale: It has 14 items, each of which is scored from 0 (i.e, severely impaired balance) to 4 (i.e., no balance impairment). * Timed Up and Go test: It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again. * Functional Reach Test: It measures the maximum distance an individual is able to reach forward beyond arm's length in the standing position when maintaining a fixed base of support. * One-leg stance test: Individuals were asked to stand on either their left or right leg. * Four square step test: It requires an individual to step over obstacles in various directions including forward, backward, and sideways. | Other | Healthy Controls, Patients with Multiple Sclerosis |
Primary outcome
The timed 360° turn test
Time frame: 1 minute
The timed 360° turn test evaluates turning ability. Higher durations indicate worse turning performance.
5 secondary outcomes
Berg Balance Scale
Time frame: 10 minutes
Timed Up and Go test
Time frame: 1 minute
Functional Reach Test
Time frame: 1 minute
Four Square Step Test
Time frame: 1 minute
One Leg Stance Test
Time frame: 3 minutes
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 21 Nov 2018.
- Background: PubMed 29879144Adusumilli G, Lancia S, Levasseur VA, Amblee V, Orchard M, Wagner JM, Naismith RT. Turning is an important marker of balance confidence and walking limitation in persons with multiple sclerosis. PLoS One. 2018 Jun 7;13(6):e0198178. doi: 10.1371/journal.pone.0198178. eCollection 2018.
- Background: PubMed 22277368Spain RI, St George RJ, Salarian A, Mancini M, Wagner JM, Horak FB, Bourdette D. Body-worn motion sensors detect balance and gait deficits in people with multiple sclerosis who have normal walking speed. Gait Posture. 2012 Apr;35(4):573-8. doi: 10.1016/j.gaitpost.2011.11.026. Epub 2012 Jan 25.
- Background: PubMed 24055784Gunn H, Creanor S, Haas B, Marsden J, Freeman J. Frequency, characteristics, and consequences of falls in multiple sclerosis: findings from a cohort study. Arch Phys Med Rehabil. 2014 Mar;95(3):538-45. doi: 10.1016/j.apmr.2013.08.244. Epub 2013 Sep 18.
- Background: PubMed 23391522Cameron MH, Asano M, Bourdette D, Finlayson ML. People with multiple sclerosis use many fall prevention strategies but still fall frequently. Arch Phys Med Rehabil. 2013 Aug;94(8):1562-6. doi: 10.1016/j.apmr.2013.01.021. Epub 2013 Feb 4.
- 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.
Fatih Söke principal investigator
Gazi 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, Relapsing-Remitting, run by Gazi 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 6 inclusion and 5 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 21 Nov 2018. 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 timed 360° turn test (time frame: 1 minute). 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 NCT03718026, which also lists 4 linked publications.
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 21 Nov 2018.