Fall Due to Loss of EquilibriumNCT04752878
Turkish Version of Ottawa Sitting Scale in Patients With Stroke
An observational study of Fall Due to Loss of Equilibrium and Acute Stroke, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fall Due to Loss of Equilibrium, Acute Stroke, Balance; Distorted
- What is being tested?
- Ottawa sitting scale
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2021to 15 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age diagnosed with acute ischemic or hemorrhagic stroke
Who may be able to join
- Diagnosed with acute stroke
- aged above 18 years
Who cannot join
- Patients who do not cooperate enough to read or approve the consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Ottawa sitting scale
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ottawa sitting scaleDiagnostic test
The Ottawa Sitting Scale is a performance-based balance measurement consisting of 10 items that aims to evaluate the sitting balance in a comprehensive, specific, efficient and functional manner.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (2)
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
Measured: 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
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start15 May 2021
- Primary completion15 Jun 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fall Due to Loss of EquilibriumStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ertuğrul Yaşa, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752878
- Sponsor's protocol ID
- 2020-363
- Status last verified
- Dec 2022
- First submitted
- 5 Feb 2021
- Last updated
- 27 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yasa ME, Aydogan Arslan S, Yildirim Sahan T, Caglar D, Savcun Demirci C, Demir P. Validity and reliability of the Turkish version of the Ottawa Sitting Scale in patients with acute stroke. Disabil Rehabil. 2024 Aug;46(17):3992-3997. doi: 10.1080/09638288.2023.2254233. Epub 2023 Sep 4.
PubMed 37665576
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Turkish Version Of The Ottawa Sitting Scale: Its Cultural Adaptation, Validation And Reliability In Patients Wıth Stroke
- ClinicalTrials.gov ID
- NCT04752878
- Acronym / sponsor ID
- 2020-363
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 12 Feb 2021 (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 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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age diagnosed with acute ischemic or hemorrhagic stroke
Key inclusion criteria (2 listed)
- Diagnosed with acute stroke
- aged above 18 years
Key exclusion criteria (1 listed)
- Patients who do not cooperate enough to read or approve the consent
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 |
|---|---|---|
| Ottawa sitting scaleThe Ottawa Sitting Scale is a performance-based balance measurement consisting of 10 items that aims to evaluate the sitting balance in a comprehensive, specific, efficient and functional manner. | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
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)
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)
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 27 Dec 2022.
- Derived from this study: PubMed 37665576Yasa ME, Aydogan Arslan S, Yildirim Sahan T, Caglar D, Savcun Demirci C, Demir P. Validity and reliability of the Turkish version of the Ottawa Sitting Scale in patients with acute stroke. Disabil Rehabil. 2024 Aug;46(17):3992-3997. doi: 10.1080/09638288.2023.2254233. Epub 2023 Sep 4.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fall Due to Loss of Equilibrium and Acute Stroke, run by Gulhane School of Medicine 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 2 inclusion and 1 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 27 Dec 2022. 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?
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)). 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 NCT04752878, which also lists 1 linked publication.
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 27 Dec 2022.