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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Istanbul, Turkey, 34147
        • Feray Güngör

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University-Cerrahpasa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yıldız Analay Akbaba, Assoc. Prof., İstanbul University-Cerrahpaşa

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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