NCT04334746

Brief Summary

The fall rate is increased parallel to the aging process. The early determination and management of falls in older adults are quite crucial to preserve the independence of older adults. In the literature, there are used many measurement tools for predicting fall status. The discriminative ability of these measures is important for the accuracy of the assessment. In this study, four of the most commonly used balance measurement tools will be investigated in terms of the discriminative ability for fall status in the Turkish community-dwelling older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 6, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

April 2, 2020

Last Update Submit

March 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fall History

    History of fallings will be determined through a question: "How many times have you fallen in the past year?". According to the participants' answers, the participants will be categorized into two groups: fallers (one or more fall events) and non-fallers (no falls).

    2 minutes

Secondary Outcomes (4)

  • One-leg Stance test

    1 minute

  • Berg Balance Scale

    20 minutes

  • Timed Up and Go Test

    3 minutes

  • Functional Reach Test

    2 minutes

Interventions

Timed Up and Go Test Functional Reach Test One-leg Stance Test Berg Balance Scale

Eligibility Criteria

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

Community-dwelling older adults

You may qualify if:

  • being aged 65 or above,
  • having a score of 21 or more from the Mini-Mental State Examination (MMSE) \[20,23\],
  • able to ambulate independently or with an assistive device.

You may not qualify if:

  • having visual and hearing problems that may cause restrictions in communication and also balance impairments,
  • drug use (benzodiazepine, psychotropic drugs, etc.) with adverse effects on balance and walking,
  • having any serious neurological, cardiopulmonary, or orthopedic disorders that adversely affected balance conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevim ACARÖZ CANDAN

Ordu, Altinordu, 52100, Turkey (Türkiye)

Location

Study Officials

  • Sevim Acaröz Candan, PhD

    Ordu University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 6, 2020

Study Start

October 6, 2020

Primary Completion

January 30, 2021

Study Completion

February 15, 2021

Last Updated

March 2, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations