Effect of Various Virtual Reality Exercise Individuals With Low Back Pain

March 21, 2023 updated by: hazal genc, Istanbul Medipol University Hospital

Effect of Different Virtual Reality Exercise in Nonspecific Individuals With Low Back Pain

Posture is defined as the best position formed by the segments that make up the body in a harmonious arrangement with each other. Muscle strength, which is one of the primary factors in providing a static or dynamic posture, is achieved thanks to the antigravity muscles that keep the body upright against gravity. Proper posture is ensured by a good body balance.

Study Overview

Status

Status

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

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.

Detailed Description

Advances in technology can influence healthcare providers to create alternative and new treatment options. SG/LV applications have also gained momentum in the field of rehabilitation. Studies have shown that 12-week programs, especially in diseases affecting the balance and vestibular system, can achieve more effective results than standard physiotherapy programs in both upper and lower extremity functions, balance, walking parameters, fall risk and cognitive parameters. The use of popular video game-based exercises, such as XBOX, or "exergaming," has evolved to become therapeutic tools for rehabilitation. Accessible as technology evolves into more and more, equipment like biodex could be an alternative way to assess and train balance

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 (Anticipated)

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.
52

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: tuğçe tahmaz, Phd(c)

Study Locations

  • Turkey
    • None Selected
      • Istanbul, None Selected, Turkey, 34353
        • Recruiting
        • Hazal GENÇ
        • Contact:
          • tuğçe tahmz, phd(c)

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-60 with nonspecific chronic low back pain

Exclusion criteria from the study:

  • Cognitive impairment
  • Disc herniation
  • Neurological deficit
  • Respiratory problems

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: balance games
virtual reality games
Device: Xbox virtual reality games
X-box balance evaluation was implemented in a completely dark and isolated room specially prepared for this treatment and evaluation
Active Comparator: balance training
Biodex balance training
Device: Biodex balance training
the Biodex Balance System SD has been designed to meet the needs of everyone looking to improve balance, increase agility, develop muscle tone and treat a wide variety of pathologies.

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
The Visual Analogue Scale (VAS)
Time Frame: 6 weeks
The Visual Analogue Scale (VAS) was used to evaluate the severity of pain, and the patients were asked to mark the level of pain they felt before and after the treatment. The VAS is a 10-centimeter straight line, the number 0 (zero) at one end indicates no pain, and the number 10 (ten) at the other end represents unbearable pain. The points marked by the patients were measured with the help of a ruler starting from the 0 point and recorded as numerical values.
6 weeks
Y Balance Test
Time Frame: 6 weeks
Y balance test, a large Y tape is drawn on the flat surface such that the angle between the front and back directions is 135 degrees, and the angle between the two back sides is 90 degrees. The person is asked to place their feet exactly in the center. It is explained that while balancing on one foot, she/he should reach anterior (front), posterolateral (posterior external), and posteromedial (posterior internal) directions with the other foot, and keep her/his weight on a stable foot. Three attempts are made before starting the test
6 weeks
Oswestry Low Back Pain Disability Questionnaire
Time Frame: 6 weeks
It is a questionnaire that aims to evaluate the disability levels and quality of life faced by patients due to low back pain. It includes 1 item related to pain and 9 items related to activities of daily living (personal care, lifting, walking, sitting, standing, sleep, sexual life, social life and travel). Each item is measured on a 6-point rank scale between 0 and 5 points according to the scenarios it contains. At the end of the survey, the scores are summed and the percentage value is calculated for the total score. High score indicates poor functional level.
6 weeks
Algometer
Time Frame: 6 weeks
The Algometer used (JTECH Medical-Algometer Commander-USA, Electronic Algometer) is a digital algometer with an LCD display, which can be used as a wrist unit or desktop system, and where measurements can be made in kilograms or Newtons.
6 weeks
Body Awareness Questionnaire
Time Frame: 6 weeks
In 13 statements, some situations in which people feel about themselves are listed. After reading each statement, they are asked to write the number in the space to the left of the statement, evaluating from 1 to 7 the degree to which the statement is true for them.
6 weeks
Flamingo Static Balance Evaluation Test:
Time Frame: 6 weeks
Flamingo balance test (FBT) is a test used for balance measurements in the Eurofit test battery.
6 weeks

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 Medipol University Hospital

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.
March 10, 2023

Primary Completion (Anticipated)

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.
May 10, 2023

Study Completion (Anticipated)

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.
July 2, 2023

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).
March 6, 2023

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.
March 7, 2023

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.
March 20, 2023

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.
March 23, 2023

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.
March 21, 2023

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.
March 1, 2023

More Information

Terms related to this study

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.
  • Virtual Reality Application

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.

Clinical Trials on Low Back Pain

Clinical Trials on Xbox virtual reality games

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings