Acute Stroke Clinical Trial
Official title:
The Turkish Version Of The Ottawa Sitting Scale: Its Cultural Adaptation, Validation And Reliability In Patients Wıth Stroke
NCT number | NCT04752878 |
Other study ID # | 2020-363 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2021 |
Est. completion date | September 15, 2022 |
Verified date | December 2022 |
Source | Gulhane School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 15, 2022 |
Est. primary completion date | June 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosed with acute stroke - aged above 18 years Exclusion Criteria: - Patients who do not cooperate enough to read or approve the consent |
Country | Name | City | State |
---|---|---|---|
Turkey | Saglik Bilimleri Üniversitesi | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gulhane School of Medicine |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ottawa sitting scale | 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 | Berg balance scale | 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) | |
Secondary | Trunk Impairment scale | 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) |
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