- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03785639
Factors Contributing to Single and Dual Task Performance of Four Square Step Tests
Factors Contributing to Single and Dual Task Performance of Four Square Step Tests in the Healthy Middle Age Group
Study Overview
Status
Conditions
Detailed Description
Participants: Healthy middle age group (50-65 years) Method: Demographic information of all participants (age, gender, body mass index), educational level (primary, undergraduate, graduate), history of falling (at least in 6 months), comorbidities (hypertension, diabetes, kidney diseases, etc.), drug using (how many per day, which one) to be examined by questionnaire and also visual impairment, the use of glasses will be recorded. Motor skills of participants; muscle strength, range of motion (ROM), gait speed (14m), Functional Reach Test will be evaluated. The Mini Mental Test and the Stroop test will be used to evaluate cognitive skills. 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. Therefore the dual task will be perform as;
1-With no prioritization 2-With prioritization (focus on balance task) 3-With prioritization (focus on cognitive task) 4-With prioritization (focus on motor task) Note: Balance task is FSST. Cognitive task is auditory N-back test. Motor task is carrying a cup of water.
Statistical Analyses:
The data will be analyzed with Statistical Package for the Social Sciences (SPSS) 21.0 package program. Descriptive statistical information will be given as mean (X) ± standard deviation (X ± SD) and minimum (min), maximum (max) frequency (f) and percentage (%). The variables will be tested for normality using the Kolmogorov-Smirnov test. When the parametrical test assumptions are obtained, the correlation between the FSST single, FSST motor and FSST cognitive is evaluated by Pearson Correlation Analysis, if the parametrical test assumptions are not obtained, Spearman Correlation Analysis will be used. Multiple linear regression analysis will be applied to determine which potential factor is effective in performance in each FSST test. As a result of the power analysis using the effect size value in the reference study for the study, it was calculated that 85% power could be obtained at 95% confidence level when at least 60 people.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kınıklı
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Denizli, Kınıklı, Turkey, 20160
- Pamukkale University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Strength
Time Frame: 20 minutes
|
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
Time Frame: 10 minutes
|
Range of motions of hip, knee and ankle will be assessed by goniometer.
|
10 minutes
|
Gait speed
Time Frame: 2 minutes
|
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
Time Frame: 2 minutes
|
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
Time Frame: 10 minutes
|
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)
Time Frame: 20 minutes
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emel TAŞVURAN HORATA, MSc, Principal Investigator
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 60116787-020/71491
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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