HealthyNCT04899804
Validity and Reliability of Tele-Assessment Based Core Performance and Functional Capacity Tests in Healthy Individuals
An observational study of Healthy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2021to 30 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy
Who may be able to join
- 18-40 years
- Does not have any diagnosed disease
- Volunteer
- Able to use the technology required for tele-assessment
Who cannot join
- Do not have the technology required for evaluations
- Not willing to participate in the study
- Who have a balance problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Keywords
- validity, reliability, telehealth, trunk endurance, functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curl-up
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.
Measured: Baseline
Modified Push-up
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.
Measured: Baseline
Plank
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.
Measured: Baseline
Lateral bridge
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.
Measured: Baseline
30 seconds sit to stand test (30STS)
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.
Measured: Baseline
Timed up and go test (TUG)
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.
Measured: Baseline
Functional reach test (FRT)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start29 May 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Feray Güngör, Istanbul University - Cerrahpasa
- Investigators
- Yıldız Analay Akbaba, Assoc. Prof., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899804
- Sponsor's protocol ID
- IUC2
- Status last verified
- Jul 2022
- First submitted
- 19 May 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gungor F, Ovacik U, Ertan Harputlu O, Yekdaneh AA, Kurt I, Erturk Uzunoglu G, Polat Ilguz B, Akuzum F, Akbaba YA. Tele-assessment of core performance and functional capacity: Reliability, validity, and feasibility in healthy individuals. J Telemed Telecare. 2024 Jul;30(6):1017-1025. doi: 10.1177/1357633X221117335. Epub 2022 Aug 2.
PubMed 35916001
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Validity and Reliability of Core Performance and Functional Capacity Tests Applied by Tele-Assessment in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04899804
- Acronym / sponsor ID
- IUC2
- Conditions
- Healthy
- Keywords
- validity, reliability, telehealth, trunk endurance, functional capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 29 May 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy
Key inclusion criteria (4 listed)
- 18-40 years
- Does not have any diagnosed disease
- Volunteer
- Able to use the technology required for tele-assessment
Key exclusion criteria (3 listed)
- Do not have the technology required for evaluations
- Not willing to participate in the study
- Who have a balance problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Curl-up
Time frame: Baseline
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.
Modified Push-up
Time frame: Baseline
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.
Plank
Time frame: Baseline
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.
Lateral bridge
Time frame: Baseline
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.
30 seconds sit to stand test (30STS)
Time frame: Baseline
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.
Timed up and go test (TUG)
Time frame: Baseline
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.
Functional reach test (FRT)
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Derived from this study: PubMed 35916001Gungor F, Ovacik U, Ertan Harputlu O, Yekdaneh AA, Kurt I, Erturk Uzunoglu G, Polat Ilguz B, Akuzum F, Akbaba YA. Tele-assessment of core performance and functional capacity: Reliability, validity, and feasibility in healthy individuals. J Telemed Telecare. 2024 Jul;30(6):1017-1025. doi: 10.1177/1357633X221117335. Epub 2022 Aug 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yıldız Analay Akbaba, Assoc. Prof. study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curl-up (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04899804, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.