NCT03785639

Brief Summary

There are many tests that evaluate fall and balance. As a clinical test, the Four Square Step Test (FSST)Test is reliable, valid, easy to score, quick to administer, requires little space, and needs no special equipment. It is unique in that it involves stepping over low objects (2.5cm) and movement in 4 directions. FSST was developed in 2002 to measure the rapid stepping that is often required when changing direction and avoiding obstacles while walking. The FSST requires a stopwatch and four single point sticks. Using the sticks resting flat on the floor to form a cross, the subject starts in one square and steps in one direction into each of the four squares and then reverses direction back to the start. The FSST is unique in that it challenges motor planning, sequencing and recall, whilst simultaneously providing clinicians with the opportunity to measure and observe a person's clearance of low obstacles at speed. The ability to clear the trail leg when stepping over an obstacle has been shown to be reduced in healthy populations. Dual task is simultaneous performance of two tasks that can be performed independently, measured separately and with different goals. Individuals have difficulties in performing two tasks together. When two tasks are performed at the same time, deterioration in performance of one or both is called dual task interference. This occurs when task requirements exceed the capacity. Age, walking speed, lower extremity muscle strength and cognitive status are factors that contribute to the dual task. In addition, prioritizing the motor or cognitive task in a dual task affects the dual task performance. Knowing these factors and improving some of them can help to create training programs designed to improve the dual task performance of individuals. There are several studies investigating factors contributing to dual task performance that focus on balance in the elderly. However, the studies including middle age group are limited. There are no studies evaluating the factors contributing to the single and dual task performance of FSST in the literature. In this study, it is aimed to explain the factors related to motor and cognitive functions to the single and dual task performance of FSST.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

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

December 14, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

December 18, 2018

Last Update Submit

September 17, 2020

Conditions

Keywords

balancedual taskFour Square Step Test

Outcome Measures

Primary Outcomes (6)

  • Muscle Strength

    Grip strength and muscle strength of low extremities will be evaluated with using hand-held dynamometer. The measured value will be recorded in newton.

    20 minutes

  • Range of motion

    Range of motions of hip, knee and ankle will be assessed by goniometer.

    10 minutes

  • Gait speed

    Gait speed will be evaluated on a flat surface and at a distance of 14 meters. The walking speed will be recorded in m/sec.

    2 minutes

  • Functional ReachTest

    The FRT assesses limits of stability by measuring the maximum distance that an individual can reach forward while standing in a fixed position. A 122 cm ruler will be fastened to the wall with tape at the height of the subject's acromion process. The subject will be instructed to make a fist and raise the arm to 90 degrees of shoulder flexion. An initial measurement will be record at the position of the subject's third metacarpal. The subject will be instructed to reach as far forward as possible while keeping the fist parallel and level with the ruler and without taking a step or touching the wall.

    2 minutes

  • Stroop Test

    This test evaluate cognitive abilities. the Stroop Test is a useful measuring tool for especially the fields of psychiatry, neurology, neurosurgery, and clinical psychology and for the basic science field of experimental psychology. The test is used to evaluate cognitive processes such as frontal lobe functions and attention, information processing periods.

    10 minutes

  • Four Square Step Test (FSST)

    FSST is designed for assessing balance. The participants will be asked to stand in square number 1 facing square number 2 and to step clockwise forward, then right, backward and left, then anticlockwise right, forward and left and finally backward. The stopwatch will start when the first foot contacted the floor in square 2 and will finish when the last foot came back to touch the floor in square 1. Single and dual task performance will be evaluated by FSST. The participants performed the FSST; FSST single: This test is consist of only FSST. FSST motor: FSST is combined with a motor task (carrying a cup of water) FSST cognitive: FSST is combined with a cognitive task (auditory N-back test) As prioritization affects dual task performance, in this study the prioritization will be used in dual task's evaluation.

    20 minutes

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Sixty healthy active (joining social activities, sports and artistic activities etc.) participants (men and women) between the ages of 50-65 will be included in the study.

You may qualify if:

  • At least to graduate from primary school or ability to read and write
  • Mini mental test score\> 24
  • Functional reach test score≥15 cm
  • Ability to walking independently in the community

You may not qualify if:

  • Living in nursing home
  • Presence of central nervous system disease (dementia, Parkinson's disease, stroke, etc.)
  • Polypharmacy (more than 6 medications per day)
  • Presence of hearing impairment that cannot be resolved by hearing devices and presence visual impairment that cannot be resolved by hearing aids.
  • Presence of musculoskeletal injuries or impairments (NEH limitation, muscle weakness, etc.), which may affect the performance in physical tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Kınıklı, 20160, Turkey (Türkiye)

Location

Related Publications (1)

  • Yogev-Seligmann G, Rotem-Galili Y, Mirelman A, Dickstein R, Giladi N, Hausdorff JM. How does explicit prioritization alter walking during dual-task performance? Effects of age and sex on gait speed and variability. Phys Ther. 2010 Feb;90(2):177-86. doi: 10.2522/ptj.20090043. Epub 2009 Dec 18.

    PMID: 20023000BACKGROUND

Study Officials

  • Emel TAŞVURAN HORATA, MSc

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 18, 2018

First Posted

December 24, 2018

Study Start

December 14, 2018

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations