- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04899804
Validity and Reliability of Tele-Assessment Based Core Performance and Functional Capacity Tests in Healthy Individuals
July 7, 2022 updated by: Feray Güngör, Istanbul University-Cerrahpasa
Investigation of the Validity and Reliability of Core Performance and Functional Capacity Tests Applied by Tele-Assessment in Healthy Individuals
The COVID-19 pandemic process has created the need for social isolation and quarantine, and restrictions have occurred in access to healthcare services.
In this process, the trend towards alternative methods that will provide access to health services and the need for telehealth services has increased.
As a result of this, when we look at the literature, evaluation methods used in the clinical environment in physiotherapy are frequently encountered in tele-evaluation.
There is a need for validity and reliability studies of these evaluation methods in terms of tele-assessment.
This study was designed to determine the validity and reliability of trunk endurance and functional capacity tests applied by the tele-assessment method in healthy individuals.
Study Overview
Status
Completed
Conditions
Detailed Description
Tele-health has become a service whose prevalence has increased in recent years with the development of technology.
Tele-health facilitates the accessibility of health services for individuals in all segments of society.
Telerehabilitation, a subcomponent of telehealth, provides easy access to rehabilitation services by reducing cost, time, and distance barriers in physiotherapy.
It offers physiotherapists the opportunity to observe the musculoskeletal system through physical assessment, exercise program planning, distance education, and continuous feedback of individuals.
In this sense, tele-assessment has an important place within the scope of health services.
As a result of the restrictions that came with the COVID-19 process, it has become difficult for individuals to access health services.
With the effective use of technology to eliminate this obstacle, telehealth has become an alternative method.
Tests such as curl-up, push-up, plank, and lateral bridge are frequently used to evaluate trunk endurance in healthy individuals.
For functional evaluation, the timed sit and test, the timed stand up and test, the functional anterior reach test and the one-foot balance test are among the most used tests in the literature.
The validity and reliability of these methods used in the face-to-face evaluation should be determined for the correct and effective tele-assessment.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34147
- Feray Güngör
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy
Description
Inclusion Criteria:
- 18-40 years
- Does not have any diagnosed disease
- Volunteer
- Able to use the technology required for tele-assessment
Exclusion Criteria:
- Do not have the technology required for evaluations
- Not willing to participate in the study
- Who have a balance problem
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Validity and Reliability Group
This study will be completed in two phases.
In the first phase, the participants included in the study will be evaluated first by tele-assessment.
One hour later, all assessments will be repeated face-to-face procedures by the researchers; thus, the validity of the tele-assessment method will be determined.
Before the tele-assessment, participants will be informed about having a chair whose floor-to-seat height is 48 cm and tape measure.
In the second phase of the study, to determine the reliability of the tele-assessment method, all tests will be applied to the previously tested participant by the same researcher one week later and at the same time of the day using only the tele-assessment method.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Curl-up
Time Frame: Baseline
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The Curl-Up test is used to evaluate the trunk flexor muscle strength.
In the test, individuals are asked to lie on their back, bring their hips and knees to a 90º flexion position, and perform trunk flexion for 30 seconds.
In our study, the result of the Curl-up test will be recorded as the number of repetitions made by individuals for 30 seconds.
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Baseline
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Modified Push-up
Time Frame: Baseline
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Push-up test is used to evaluate general core muscle strength.
In the test, individuals are asked to lie in the prone position, bring their hands to shoulder level, their elbows in flexion and to the side of the body, while in this position, they are asked to raise the head, shoulder and trunk with the elbows fully extended for 30 seconds.
In our study, the number of repetitions performed by the subjects for 30 seconds will be recorded.
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Baseline
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Plank
Time Frame: Baseline
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Plank test will be applied to evaluate general core endurance.
Participants will be positioned so that their forearms and toes are on the ground and they will be asked to lift their trunk by giving weight.
Participants will be informed about the correct alignment of the whole body during the test.
The time in which the body's position is maintained will be recorded in seconds and the test will be terminated as soon as the position is broken.
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Baseline
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Lateral bridge
Time Frame: Baseline
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The lateral bridge test is used to test the endurance of the lateral trunk muscles.
n the test, the person lying on his back is asked to turn sideways on one side, place his forearm on the ground at an angle of 90º with the arm, and cross his upper arm to the opposite shoulder.
The subject is asked to lift his body up on his forearm and toes while in this position and to maintain this position.
In our study, with the lateral bridge test, the time that the patients stand without disturbing the movement will be recorded in seconds by means of the stopwatch, the test will be repeated twice for both sides and the best result will be evaluated.
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Baseline
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30 seconds sit to stand test (30STS)
Time Frame: Baseline
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30STS is used to evaluate lower extremity functionality and dynamic balance.
A chair with a hard seat which a floor-to-seat height of 48 cm will be stabilized.
Participants will be asked to sit with their feet flat on the ground and their upper limbs crossed to their chest.
Participants will be asked to stand up and sit for 30 seconds and the number of repetitions will be recorded.
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Baseline
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Timed up and go test (TUG)
Time Frame: Baseline
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TUG is used to measure basic mobility.
Time is registered from when the participant arises, walks 3 m, turns around, walks back, and sits down again.
A test trial will be allowed, and two attempts will be registered.
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Baseline
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Functional reach test (FRT)
Time Frame: Baseline
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FRT is an outcome measure used to assess dynamic balance in a task.
In standing, the distance between the length of an outstretched arm in a maximal forward reach will be measured, while maintaining a fixed base of support.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Yıldız Analay Akbaba, Assoc. Prof., Istanbul University-Cerrahpasa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2021
Primary Completion (Actual)
March 30, 2022
Study Completion (Actual)
March 30, 2022
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
May 21, 2021
First Posted (Actual)
May 24, 2021
Study Record Updates
Last Update Posted (Actual)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 7, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- IUC2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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