Multiple SclerosisNCT06308042
Remote Evaluation in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Inonu University.
Trial summary
This study aimed to demonstrate the remote reliability of the 30-second sit-to-stand 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
- What is being tested?
- 30 second sit and stand test
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2024to 29 Jun 2024
- 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 been diagnosed with MS according to the McDonald criteria by a neurologist
- having and being able to use a device with Internet access (e.g. smartphone, computer or tablet)
- having EDSS between 1.5 and 6.5,
- being between the ages of 18-65.
Who cannot join
- Patients who have had a recurrence of the disease in the last 30 days,
- have an additional health problem (orthopedic, neurological, internal or cardiorespiratory) that prevents standing/walking,
- do not agree to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Remote Reliability Of 30 Seconds Sit And Stand Test In Patients With Multiple Sclerosis
This study aimed to demonstrate the remote reliability of the 30-second sit-to-stand test in patients with multiple sclerosis.
Read the detailed description
The population of the research will be participants with multiple sclerosis. The 30-second sit-to-stand test will be performed in the participant's home environment. . Patients will be instructed to cross their arms over their chest and complete as many standing cycles as possible in 30 seconds, standing until fully upright and then sitting until the hips touch the chair without the assistance of the hands. Inter-rater reliability will be assessed by two different raters in the same video interview. In contrast, intra-rater reliability will be evaluated by analyzing the number of repetitions recorded by the same rater in two different video interviews conducted 24-28 hours apart.
- Conditions
- Multiple Sclerosis
- Being tested
- 30 second sit and stand test
- Keywords
- 30 SECONDS SIT AND STAND TEST, REMOTE RELIABILITY
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 second sit and stand testOther
The individual sits in the middle of the chair with his back upright, his feet on the ground, and his arms crossed in front of his chest. The individual starts the test with the start command while in this position and takes off as fully as he can for 30 seconds.
What is being measured
The primary outcome is the main question the study is designed to answer.
30 second sit and stand test
The 30-second sit-to-stand test is a test used to evaluate lower extremity muscle strength, balance and walking functions.
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start11 Mar 2024 (estimated)
- Primary completion24 Jun 2024 (estimated)
- Study completion29 Jun 2024 (estimated)
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.
- More trials run by Inonu 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
- Investigators
- Burcu talu, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308042
- Sponsor's protocol ID
- 2024/5558
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data can be shared with other researchers if desired
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Reliability Of 30 Seconds Sit And Stand Test In Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06308042
- Acronym / sponsor ID
- 2024/5558
- Conditions
- Multiple Sclerosis
- Keywords
- 30 SECONDS SIT AND STAND TEST, REMOTE RELIABILITY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 11 Mar 2024 (estimated)
- Primary completion
- 24 Jun 2024 (estimated)
- Study completion
- 29 Jun 2024 (estimated)
- First posted
- 13 Mar 2024 (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.
This study aimed to demonstrate the remote reliability of the 30-second sit-to-stand test in patients with multiple sclerosis.
Detailed description
The population of the research will be participants with multiple sclerosis. The 30-second sit-to-stand test will be performed in the participant's home environment. . Patients will be instructed to cross their arms over their chest and complete as many standing cycles as possible in 30 seconds, standing until fully upright and then sitting until the hips touch the chair without the assistance of the hands. Inter-rater reliability will be assessed by two different raters in the same video interview. In contrast, intra-rater reliability will be evaluated by analyzing the number of repetitions recorded by the same rater in two different video interviews conducted 24-28 hours apart.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
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 (4 listed)
- Having been diagnosed with MS according to the McDonald criteria by a neurologist
- having and being able to use a device with Internet access (e.g. smartphone, computer or tablet)
- having EDSS between 1.5 and 6.5,
- being between the ages of 18-65.
Key exclusion criteria (3 listed)
- Patients who have had a recurrence of the disease in the last 30 days,
- have an additional health problem (orthopedic, neurological, internal or cardiorespiratory) that prevents standing/walking,
- do not agree to participate 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 |
|---|---|---|
| 30 second sit and stand testThe individual sits in the middle of the chair with his back upright, his feet on the ground, and his arms crossed in front of his chest. The individual starts the test with the start command while in this position and takes off as fully as he can for 30 seconds. | Other | – |
Primary outcome
30 second sit and stand test
Time frame: 24-48 hours
The 30-second sit-to-stand test is a test used to evaluate lower extremity muscle strength, balance and walking functions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Yes. Study data can be shared with other researchers if desired
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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.
Burcu talu study director
Inonu University
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Inonu University.
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 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DILAN DEMİRTAŞ KARAOBA (0554112779, dilandemirtas92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 second sit and stand test (time frame: 24-48 hours). 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 13 Mar 2024.