NCT04615533

Brief Summary

Fraility; It is an age-related biological syndrome. It is characterized by decreased resistance to stressors due to changes in functional reserves and physiological systems. BESTest, which is frequently used in the literature, was modified and Frail'BESTest was developed to detect balance problems in fragile individuals. The test consists of 6 subtitles. These are participation, reaction, movement ability, sensory organization, biomechanical constraints, gait symmetry. When looking at the literature, the Turkish version of Frail'BESTest has not been found. For this reason, the aim of study is to examine the validity and reliability of the Turkish version of Frail'BESTest in elderly individuals and to question the effectiveness of its clinical use and to bring it to the use of other researchers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 25, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

October 29, 2020

Last Update Submit

January 20, 2022

Conditions

Frail Elderly SyndromeBalance; DistortedAssessment, Self

Outcome Measures

Primary Outcomes (5)

  • Frail'BESTest

    The test consists of 6 subtitles. These are participation, reaction, movement ability, sensory organization, biomechanical constraints, gait symmetry.

    Day 1

  • Clinical Frailty Scale

    Scale evaluates physical weaknesses such as comorbidity, cognitive impairment, and disability. Scale scoring is from 1 (very favorable) to 9 (terminally ill)

    Day 1

  • Mini BESTest

    The Mini-BESTest consists of 14 items and evaluates 4 different components of dynamic balance (1) antispatient postural adjustments, (2) reactive postural control, (3) sensory orientation and (4) dynamic walking).

    Day 1

  • Berg Balance Test

    The BBS consists of 14 items to directly monitor the maintenance of body balance during performance

    Day 1

  • Tinetti Balance and Gait Test

    In the test used to evaluate balance, walking score is maximum 12 points, balance score is maximum 16 points and a total of 28 points

    Day 1

Study Arms (1)

Frail older adults, assessment

Frail older adults, assessment Frail'BESTest, Clinical Frailty Scale, Mini BESTest, Berg Balance Scale, Tinetti Blance and Gait Scale

Other: Frail older adults, assessment

Interventions

Frail older adults, assessmentOTHER

Frail'BESTest, Clinical Frailty Scale, Mini BESTest, Berg Balance Scale, Tinnetti Balance and gait sacale

Frail older adults, assessment

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals aged 65 and over, Volunteering to participate in research, No cooperation and communication problem

You may qualify if:

  • Individuals aged 65 and over,
  • Your willingness to participate in research Elderly individuals with a diagnosis of frailty
  • No cooperation and communication problems

You may not qualify if:

  • Individuals with neurological and orthopedic problems Uncontrollable hypertension
  • Those with cardiac disease
  • Those with cooperation and communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Abit Kocaman

Kırıkkale, 7110, Turkey (Türkiye)

Location

Related Publications (1)

  • Kubicki A, Brika M, Coquisart L, Basile G, Laroche D, Mourey F. The Frail'BESTest. An Adaptation of the "Balance Evaluation System Test" for Frail Older Adults. Description, Internal Consistency and Inter-Rater Reliability. Clin Interv Aging. 2020 Jul 30;15:1249-1262. doi: 10.2147/CIA.S247332. eCollection 2020.

    PMID: 32801673BACKGROUND

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Ayşe Abit Kocaman

    Kırıkkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 4, 2020

Study Start

October 25, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

January 21, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)