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出境医 / 临床实验 / Intra and Inter Reliability and Validity of the Turkish Version of Ottowa Sitting Scale in Intensive Care Unit Survivors

Intra and Inter Reliability and Validity of the Turkish Version of Ottowa Sitting Scale in Intensive Care Unit Survivors

Study Description
Brief 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.

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.


Condition or disease
Intensive Care (ICU) Myopathy Functional Disturbance

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
Layout table for study information
Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Intra and Inter Reliability and Validity of the Turkish Version of Ottowa Sitting Scale in Intensive Care Unit Survivors
Actual Study Start Date : February 13, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 30, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
80
Criteria

Inclusion Criteria:

  1. Volunteer to participate in the study
  2. To understand Turkish commands
  3. To be able to be independent in the previous functional status
  4. Sleep at least 24 hours in intensive care

Exclusion Criteria:

  1. Do not want to participate in the study
  2. Central or peripheral neurological damage
  3. Don't understand Turkish commands
  4. Unconsciousness
  5. Arrhythmia
  6. Acute myocardial infarction
  7. Hemodynamic instability (Blood pressure> 200 or <80; Heart rate <40 or> 130, O2 saturation <88%)
Contacts and Locations

Locations
Layout table for location information
Turkey
Izmir University of Health Sciences Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
İzmir, Cigli, Turkey
Sponsors and Collaborators
Izmir Katip Celebi University
Investigators
Layout table for investigator information
Study Director: Ilknur Gursan Izmir Katip Celebi University
Tracking Information
First Submitted Date April 30, 2019
First Posted Date May 3, 2019
Last Update Posted Date May 3, 2019
Actual Study Start Date February 13, 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intra and Inter Reliability and Validity of the Turkish Version of Ottowa Sitting Scale in Intensive Care Unit Survivors
Official Title Intra and Inter Reliability and Validity of the Turkish Version of Ottowa Sitting Scale in Intensive Care Unit Survivors
Brief 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.

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 Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 80
Condition
  • Intensive Care (ICU) Myopathy
  • Functional Disturbance
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: May 2, 2019)
80
Original Actual Enrollment Same as current
Estimated Study Completion Date September 30, 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Volunteer to participate in the study
  2. To understand Turkish commands
  3. To be able to be independent in the previous functional status
  4. Sleep at least 24 hours in intensive care

Exclusion Criteria:

  1. Do not want to participate in the study
  2. Central or peripheral neurological damage
  3. Don't understand Turkish commands
  4. Unconsciousness
  5. Arrhythmia
  6. Acute myocardial infarction
  7. Hemodynamic instability (Blood pressure> 200 or <80; Heart rate <40 or> 130, O2 saturation <88%)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03936920
Other Study ID Numbers IzmırIKCU
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Busra Aktas, Izmir Katip Celebi University
Study Sponsor Izmir Katip Celebi University
Collaborators Not Provided
Investigators
Study Director: Ilknur Gursan Izmir Katip Celebi University
PRS Account Izmir Katip Celebi University
Verification Date May 2019