NCT03936920

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

April 30, 2019

Last Update Submit

May 2, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

80

You may qualify if:

  • 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

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir University of Health Sciences Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital

Izmir, Cigli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Ilknur Gursan

    Izmir Katip Celebi University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 3, 2019

Study Start

February 13, 2019

Primary Completion

August 1, 2019

Study Completion

September 30, 2019

Last Updated

May 3, 2019

Record last verified: 2019-05

Locations