- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06308042
Remote Evaluation in Patients With Multiple Sclerosis
March 6, 2024 updated by: Burcu Talu, Inonu University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: DILAN DEMİRTAŞ KARAOBA
- Phone Number: 0554112779
- Email: dilandemirtas92@gmail.com
Study Contact Backup
- Name: : BUSRA CANDIRI
- Phone Number: 05073780717
- Email: candiri_17@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
multiple sclerosis patients
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24-48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Burcu talu, Inonu University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 11, 2024
Primary Completion (Estimated)
June 24, 2024
Study Completion (Estimated)
June 29, 2024
Study Registration Dates
First Submitted
March 6, 2024
First Submitted That Met QC Criteria
March 6, 2024
First Posted (Actual)
March 13, 2024
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/5558
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Study data can be shared with other researchers if desired
IPD Sharing Time Frame
After the study was published
IPD Sharing Access Criteria
If requested from the authors, it can be shared with researchers at the authors' discretion.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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