NCT04899804

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

May 29, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

May 19, 2021

Last Update Submit

July 7, 2022

Conditions

Keywords

validityreliabilitytelehealthtrunk endurancefunctional capacity

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy

You may qualify if:

  • years
  • Does not have any diagnosed disease
  • Volunteer
  • Able to use the technology required for tele-assessment

You may not qualify if:

  • Do not have the technology required for evaluations
  • Not willing to participate in the study
  • Who have a balance problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feray Güngör

Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Officials

  • Yıldız Analay Akbaba, Assoc. Prof.

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, Research Assistant

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

May 29, 2021

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations