- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04752878
Turkish Version of Ottawa Sitting Scale in Patients With Stroke
The Turkish Version Of The Ottawa Sitting Scale: Its Cultural Adaptation, Validation And Reliability In Patients Wıth Stroke
The aim of the study is to describe the cultural adaptation of the Ottawa Sitting Scale and to examine the factor structure, reliability and validity of the scale in patients with stroke.
The scale will be translated into Turkish language by following the procedure. 80 patients will be recruited in the study. Berg Balance Scale and Trunk Impairment Scale will be included with Turkish Ottawa Sitting Scale to test the validity. Outcome measures will be repeated by a second physiotherapist the day after the first assessment for interrater reliability and conducted twice within 2 weeks (test-retest) for reliability.
The interrater and intrarater reliability of the Ottawa sitting scale will be determined using intraclass correlation coefficients and internal consistency will be assessed using Cronbach's alpha.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Mustafa Ertuğrul yaşa, ass. prof.
- Phone Number: +905368584105
- Email: mustafaertugrul.yasa@sbu.edu.tr
Study Locations
-
-
-
Ankara, Turkey, 06310
- Sağlık Bilimleri Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosed with acute stroke
- aged above 18 years
Exclusion Criteria:
- Patients who do not cooperate enough to read or approve the consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ottawa sitting scale
Time Frame: Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)
|
A balance measurement scale for acute stroke patients.
The scale tests the patient on a total of 10 items while sitting, with 5 items with eyes open and 5 items with eyes closed.
An ordered scale (0-4) is used to score each item.
The total score range of the scale is 0-40.
Higher scores indicate a better outcome
|
Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg balance scale
Time Frame: Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)
|
A balance measurement to determine the risk of falls.
The scale consists of 14 items.
Each item is scored between 0 and 4. 4 points indicate the ability to complete the task independently, 0 points indicate the failure to start the task.
According to the scores, the cases are divided into groups as "high risk of falling (0-20 points)", "moderate fall risk (21-40 points)", "low risk of falling (41-56 points)" and the highest score 56 is considered to show the best balance
|
Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)
|
Trunk Impairment scale
Time Frame: Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)
|
A scale to evaluate motor disorders in the trunk after stroke.
This scale consists of 3 sub-sections and 17 items that evaluate static sitting balance, dynamic sitting balance and coordination.
The maximum score of the test is 40 points.
High scores indicate good balance
|
Measurements will start with the first patient hospitalized (estimated in March 2021) and end with the evaluation of the 80th patient (estimated period of 12 months)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-363
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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