Intensive Care (ICU) MyopathyNCT03936920
Intra and Inter Reliability and Validity of the Turkish Version of Ottowa Sitting Scale in Intensive Care Unit Survivors
An observational study of Intensive Care (ICU) Myopathy and Functional Disturbance, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Introduction-Objective: Balance evaluation is one of the most important components of physical examination. Studies on equilibrium assessment in different research groups; It includes measurements that assess the seating balance, which does not require complex measurements or ambulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care (ICU) Myopathy, Functional Disturbance
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2019to 30 Sep 2019
- 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: 80
Who may be able to join
- Volunteer to participate in the study
- To understand Turkish commands
- To be able to be independent in the previous functional status
- Sleep at least 24 hours in intensive care
Who cannot join
- Do not want to participate in the study
- Central or peripheral neurological damage
- Don't understand Turkish commands
- Unconsciousness
- Arrhythmia
- Acute myocardial infarction
- Hemodynamic instability (Blood pressure> 200 or <80; Heart rate <40 or> 130, O2 saturation <88%)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir University of Health Sciences Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
Izmir, Cigli
About this study
Introduction-Objective: Balance evaluation is one of the most important components of physical examination. Studies on equilibrium assessment in different research groups; It includes measurements that assess the seating balance, which does not require complex measurements or ambulation.
In the literature, there is no clear information about balance effect in intensive care patients who can not be ambulated due to loss of advanced muscle strength, especially in the early period.
Read more
Ottowa Sitting Scale is a scale in which the balance is evaluated in the sitting position and it has no validity and reliability in Turkish.
Therefore, the aim of this study is to examine the reliability and validity of the Ottowa Sitting Scale Turkish version between measurements and measurements.
Read the detailed description
In recent years, the mortality rate has decreased in an intensive care unit with the medical and technological developments related to intensive care treatments and the rate of discharge from intensive care unit (ICU) has increased. However, as the length of hospitalization in the intensive care unit prolonged, the functionalities of the patients were restricted due to changes in the musculoskeletal and cardiovascular system. Inactivity, inflammation, the use of pharmacological agents and the presence of neuromuscular syndromes associated with the critical disease lead to decreased muscle dysfunction and exercise tolerance in patients in the intensive care unit. These changes cause the health-related quality of life to be worse in people with critical illness a few months after discharge. Balance; muscle strength is affected by changes in sensory information, postural control and vestibular arrangements from the lower extremity. Studies on equilibrium assessment in different research groups; It includes measurements that assess the seating balance, which does not require complex measurements or ambulation. In the literature, there is no clear information about balance effect in intensive care patients who can not be ambulated due to loss of advanced muscle strength, especially in the early period. The Ottowa Sitting Scale is a scale in which the balance is evaluated in the sitting position and there is no validity and reliability in Turkish. For this reason, the aim of this study is to examine the reliability and validity between measurements and measurements of the Ottowa Sitting Scale's Turkish version. More than one physiotherapist scores patients for validity between the measurements. For the validity of the measurements, a physiotherapist scores the patient twice in two weeks intervals.
- Medical subject headings
- Muscular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Ottowa Sitting Scale
It is a scale that does not require ambulation, is able to maintain static sitting position in the sitting position, can move in short distance, can move long distance, body rotation ability and ability to move on the hip can be fulfilled. The scoring of each unit varies between 0-4 and the maximum score is 40.
Measured: 1 day
Functional Independence Scale (FIM)
FIM shows the degree of independence in the basic physical and cognitive activities of the individual in daily life. FIM consists of 18 questions and mainly measures 2 parameters (1- physical / motor function, 2- cognitive / cognitive function). Each item is scored at 7 levels (1-7), 'level 1 yardım means full help, and Her level 7 lan means full independence. FIM total score is between 18-126 points. The higher the individual's score, the higher the level of independence.
Measured: 1 day
Berg Balance Test
It consists of 14 questions in which it is evaluated whether or not the balance related tasks can be fulfilled in the changing spectrum from sitting position to standing up to one foot. 0: cannot do 4: is scored as doing independently. The total score is 56. The risk of a fall from 0 to 20 is high, the risk of a fall from 21 to 40 is considered to be low and the risk of a fall from 41 to 56 is considered low.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start13 Feb 2019
- Primary completionAug 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care (ICU) MyopathyStudies 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Aktas, Izmir Katip Celebi University
- Investigators
- Ilknur Gursan, Study director, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936920
- Sponsor's protocol ID
- IzmırIKCU
- Status last verified
- May 2019
- First submitted
- 30 Apr 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra and Inter Reliability and Validity of the Turkish Version of Ottowa Sitting Scale in Intensive Care Unit Survivors
- ClinicalTrials.gov ID
- NCT03936920
- Acronym / sponsor ID
- IzmırIKCU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 3 May 2019 (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.
Introduction-Objective: Balance evaluation is one of the most important components of physical examination. Studies on equilibrium assessment in different research groups; It includes measurements that assess the seating balance, which does not require complex measurements or ambulation.
In the literature, there is no clear information about balance effect in intensive care patients who can not be ambulated due to loss of advanced muscle strength, especially in the early period.
Ottowa Sitting Scale is a scale in which the balance is evaluated in the sitting position and it has no validity and reliability in Turkish.
Therefore, the aim of this study is to examine the reliability and validity of the Ottowa Sitting Scale Turkish version between measurements and measurements.
Detailed description
In recent years, the mortality rate has decreased in an intensive care unit with the medical and technological developments related to intensive care treatments and the rate of discharge from intensive care unit (ICU) has increased. However, as the length of hospitalization in the intensive care unit prolonged, the functionalities of the patients were restricted due to changes in the musculoskeletal and cardiovascular system. Inactivity, inflammation, the use of pharmacological agents and the presence of neuromuscular syndromes associated with the critical disease lead to decreased muscle dysfunction and exercise tolerance in patients in the intensive care unit. These changes cause the health-related quality of life to be worse in people with critical illness a few months after discharge. Balance; muscle strength is affected by changes in sensory information, postural control and vestibular arrangements from the lower extremity. Studies on equilibrium assessment in different research groups; It includes measurements that assess the seating balance, which does not require complex measurements or ambulation. In the literature, there is no clear information about balance effect in intensive care patients who can not be ambulated due to loss of advanced muscle strength, especially in the early period. The Ottowa Sitting Scale is a scale in which the balance is evaluated in the sitting position and there is no validity and reliability in Turkish. For this reason, the aim of this study is to examine the reliability and validity between measurements and measurements of the Ottowa Sitting Scale's Turkish version. More than one physiotherapist scores patients for validity between the measurements. For the validity of the measurements, a physiotherapist scores the patient twice in two weeks intervals.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80
Key inclusion criteria (4 listed)
- Volunteer to participate in the study
- To understand Turkish commands
- To be able to be independent in the previous functional status
- Sleep at least 24 hours in intensive care
Key exclusion criteria (7 listed)
- Do not want to participate in the study
- Central or peripheral neurological damage
- Don't understand Turkish commands
- Unconsciousness
- Arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ottowa Sitting Scale
Time frame: 1 day
It is a scale that does not require ambulation, is able to maintain static sitting position in the sitting position, can move in short distance, can move long distance, body rotation ability and ability to move on the hip can be fulfilled. The scoring of each unit varies between 0-4 and the maximum score is 40.
Functional Independence Scale (FIM)
Time frame: 1 day
FIM shows the degree of independence in the basic physical and cognitive activities of the individual in daily life. FIM consists of 18 questions and mainly measures 2 parameters (1- physical / motor function, 2- cognitive / cognitive function). Each item is scored at 7 levels (1-7), 'level 1 yardım means full help, and Her level 7 lan means full independence. FIM total score is between 18-126 points. The higher the individual's score, the higher the level of independence.
Berg Balance Test
Time frame: 1 day
It consists of 14 questions in which it is evaluated whether or not the balance related tasks can be fulfilled in the changing spectrum from sitting position to standing up to one foot. 0: cannot do 4: is scored as doing independently. The total score is 56. The risk of a fall from 0 to 20 is high, the risk of a fall from 21 to 40 is considered to be low and the risk of a fall from 41 to 56 is considered low.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
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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.
Ilknur Gursan study director
Izmir Katip Celebi University
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 Intensive Care (ICU) Myopathy and Functional Disturbance, run by Izmir Katip Celebi University 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 4 inclusion and 7 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 3 May 2019. 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?
Results are not available in the source record.
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?
Ottowa Sitting Scale (time frame: 1 day). The study lists 3 primary outcomes in all. 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 3 May 2019.