Comparison of Technology-assisted and Face-to-face Assessment in Patients With Low Back Pain

May 8, 2024 updated by: Muhammed Zahid Uz, Izmir Katip Celebi University

Face-to-Face and Technology-Used Balance, Mobility and Strength Assessment in Patients With Low Back Pain

Although the concepts of telemedicine and tele-rehabilitation have been frequently emphasized in recent years, the evaluation part remains inadequate. There is no study investigating remote technology-based balance, mobility and strength assessments in patients with low back pain. Therefore, the aim of the study is; It is the examination of face-to-face and technology-based remote balance, mobility and strength assessment in patients with low back pain.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
Interventional

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.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
      • İzmir, Turkey
        • Izmir Kâtip Çelebi University Vocational School of Health Services

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Those over the age of 18
  • People who can read and write
  • Patients who have not undergone surgery
  • Those whose body mass index is less than 30 m2/kg
  • Volunteering to participate in the study

Exclusion criteria

  • Patients who underwent surgery due to disc herniation
  • Having any spinal pathology
  • Having an uncontrolled neurological and metabolic disease
  • Having a spinal deformity such as scoliosis or kyphosis
  • Those with serious orthopedic, vascular, neurological or psychiatric problems that affect balance

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tele-evulation
Face-to-face tests will be recorded by video and re-evaluation will be made over the video by another person who has not performed the tests. During technology-based remote evaluations, the evaluator will monitor the tests simultaneously via video. During technology-based remote evaluations, video recording will be made and a re-evaluation will be made over the video by another person who has not performed the tests.
Other: Tele-evaluation
Evaluations will be carried out in two different environments: face-to-face in the clinic and remotely using technology. Face-to-face applications and remote evaluations using technology will be repeated once. Face-to-face applications will be made to individuals with low back pain who come to Bozyaka Training and Research Hospital and volunteer to participate in the study. Then, patients will be video-called at home, asked to perform the tests twice as taught, and recorded as a video.
Other Names:
  • Face to face evaluation
Experimental: Face-to face evulation
Face-to-face applications were carried out with individuals with low back pain who came to Bozyaka Training and Research Hospital and volunteered to participate in the study.
Other: Tele-evaluation
Evaluations will be carried out in two different environments: face-to-face in the clinic and remotely using technology. Face-to-face applications and remote evaluations using technology will be repeated once. Face-to-face applications will be made to individuals with low back pain who come to Bozyaka Training and Research Hospital and volunteer to participate in the study. Then, patients will be video-called at home, asked to perform the tests twice as taught, and recorded as a video.
Other Names:
  • Face to face evaluation

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
Oswestry disability index
Time Frame: An evaluation was made once at the beginning of the research.
The Oswestry Disability Questionnaire is a self-assessment tool that allows patients to assess the various constraints encountered during their daily activities. Utilizing a comprehensive scoring system ranging from 0 to 100, higher scores on the questionnaire indicate a heightened level of disability.
An evaluation was made once at the beginning of the research.
Timed-up and go test
Time Frame: An evaluation was made once at the beginning of the research.
Simmonds et al. (1998) researched to ascertain the reliability of this test in swiftly and practically demonstrating functional status among patients with low back pain. The assessment involves the patient transitioning from seated to standing, traversing a 3-meter-long path, executing a turn, and returning to a seated posture. The duration of this performance is meticulously recorded
An evaluation was made once at the beginning of the research.
Single Leg Stance Test
Time Frame: An evaluation was made once at the beginning of the research.
This examination, focused on assessing balance and static standing capacity, also offers insights into individuals' susceptibility to falls. During the evaluation process, participants were instructed to elevate their foot on their unaffected side and sustain this position for as long as possible. The termination of the test was determined by either contact of the free leg with the ground or a notable increase in arm oscillations
An evaluation was made once at the beginning of the research.
Thirty Second Chair Stand Test
Time Frame: An evaluation was made once at the beginning of the research.
The Thirty Second Chair Stand Test is a validated and reliable assessment modality to gauge lower extremity strength (7). During the administration of this test, participants were tasked with repeatedly rising from and sitting back down on a chair within a 30-second timeframe, with the total number of repetitions recorded. A chair with a standardized sitting height of 43 cm was utilized for the assessments, and for safety precautions, it was positioned against a wall.
An evaluation was made once at the beginning of the research.

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.
Izmir Katip Celebi University

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.
Dokuz Eylul University
Bozyaka Training and Research Hospital

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 Chair: Muhammed Zahid Uz, Master, Izmir Katip Celebi University

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.
August 10, 2022

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.
January 15, 2024

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 10, 2024

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 4, 2024

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 7, 2024

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 8, 2024

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.
May 10, 2024

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.
May 8, 2024

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.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2022/142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We aim to turn our research into an article and publish it in scientific journals.

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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Conditions

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Dietary Supplements

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