Factors Contributing to Single and Dual Task Performance of Four Square Step Tests
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| ClinicalTrials.gov Identifier: NCT03785639 |
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Recruitment Status :
Completed
First Posted : December 24, 2018
Last Update Posted : September 18, 2020
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| Condition or disease |
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| Aging |
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 : | Observational |
| Actual Enrollment : | 60 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Factors Contributing to Single and Dual Task Performance of Four Square Step Tests in the Healthy Middle Age Group |
| Actual Study Start Date : | December 14, 2018 |
| Actual Primary Completion Date : | August 31, 2020 |
| Actual Study Completion Date : | August 31, 2020 |
- 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.
- Range of motion [ Time Frame: 10 minutes ]Range of motions of hip, knee and ankle will be assessed by goniometer.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785639
| Turkey | |
| Pamukkale University | |
| Denizli, Kınıklı, Turkey, 20160 | |
| Principal Investigator: | Emel TAŞVURAN HORATA, MSc | Principal Investigator |
| Responsible Party: | Suat EREL, Principal Investigator, Pamukkale University |
| ClinicalTrials.gov Identifier: | NCT03785639 |
| Other Study ID Numbers: |
60116787-020/71491 |
| First Posted: | December 24, 2018 Key Record Dates |
| Last Update Posted: | September 18, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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balance dual task Four Square Step Test |

