NCT05072366

Brief Summary

The Joint International Commission (JCI) defines a fall as an unplanned, abrupt, change of motion towards the ground that may result in physical injury. Falls are among the most obvious reasons for applying to health centers after an involuntary external injury. Risk of falls diagnostic tools; It is used to reduce the incidence of falls, to reduce the severity of falls, to increase walking and existing functional status, to determine the factors causing falls and to keep them under control, and to raise awareness of health personnel about falls. This study aims to make the Turkish cultural adaptation of the Tinetti Fall Efficiency Scale, to test the validity and reliability of the factorial structure in elderly individuals. It was planned to determine that it is specific and sensitive. The Fall Efficiency Scale (DAS) was developed based on the definition of this fear as "low perceived self-efficacy in avoiding falls during harmless activities of daily living".

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
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

September 19, 2021

Last Update Submit

August 16, 2022

Conditions

Keywords

FallingGaitBalanceGeriatrics

Outcome Measures

Primary Outcomes (7)

  • Socio-demographic Information Form

    Demographic data of individuals (age, gender, educational status, occupation, marital status) will be questioned. Height (m), weight (kg) were recorded and body mass index (BMI) will be determined as body weight/height2 (kg/m2). Medications used, additional diseases, backgrounds will be recorded in the socio-demographic information forms of the individuals.

    through study completion, an average of six months

  • Standardized Mini Mental Test

    The scale, which consists of 11 items, gathered under five main headings as orientation, recording memory, attention and calculation, recall and language, is evaluated over a total of 30 points. While the maximum score on this scale is 30, scores below 20 in adults indicate cognitive impairment. The ideal threshold value of MMDT was found to be 24.

    through study completion, an average of six months

  • Fall Efficacy Scale

    Evaluates the activities of daily living in 10 different activities by scoring "on a scale of 1 to 10, where 1 is very confident and 10 is very confident, how sure are you that you can do the following activities without falling?"; A total score above 70 indicates that the person has a fear of falling.

    through study completion, an average of six months

  • Fall Risk Self-Assessment Scale

    It is a scale that evaluates the risk of falling in the elderly. It consists of 13 items assessing the risk of falling in the elderly. The answers are yes (1 point) and no (0 points), and individuals who score 4 points or more from the score are classified as having a high risk of falling.

    through study completion, an average of six months

  • Activity-Specific Balance Confidence Scale

    Individuals were asked 16 questions about how confidently they performed the movements they performed during daily life and were asked to give a score between 0 and 100. At the end of the test, the scores were summed up and divided by 16 to obtain the individual's ABC score. A high value indicates that the individual feels confident about balance.

    through study completion, an average of six months

  • Time up and go

    A score ≥ 13.5 s indicated a high risk of falling. The patient was asked to get up from the chair he was sitting in, walk 3 meters (at his own walking pace), then go back and sit on the chair again, and the total time spent was recorded. The patient was allowed to use the arm of the chair when getting up from the chair and to use an assistive device during this test.

    through study completion, an average of six months

  • Tinetti Balance and Gait Test

    In the test used to evaluate balance, the walking score is a maximum of 12 points, the balance score is a maximum of 16 points and a total of 28 points. Those who score twenty-six and below are considered to have a problem. Studies have shown that the lower the score, the higher the risk of falling.

    through study completion, an average of six months

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

It is planned to conduct a study with elderly inpatients at the Izmir Governor's Private Empathy Care Center. Turkish volunteers aged 65 and over.

You may qualify if:

  • Being 65 years old and over,
  • Not having a cooperation problem (individuals with a mini mental test score \>24),
  • Not having communication difficulties or problems
  • Voluntarily accepts participation in the research.

You may not qualify if:

  • Those with uncontrollable hypertension, heart disease, cardiac arrhythmia, cardiovascular disease,
  • Those who have malignancy and cause malignancy, receive chemotherapy, radiotherapy,
  • Those who have any neurological or orthopedic disorder that will disrupt the balance,
  • Individuals who are addicted to alcohol and drugs,
  • Those who do not accept to participate in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, 71000, Turkey (Türkiye)

Location

Related Links

Study Officials

  • Melahat S. DURMUŞ, PT

    Kırıkkale University

    STUDY CHAIR
  • Meral SERTEL, Assoc. Prof

    Kırıkkale University

    STUDY DIRECTOR
  • Saniye AYDOĞAN, Dr.

    Kırıkkale University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

September 19, 2021

First Posted

October 8, 2021

Study Start

March 31, 2022

Primary Completion

December 30, 2022

Study Completion

December 31, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations