- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05776992
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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
52
Phase
- 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
- Name: HAZAL genç, phd
- Phone Number: 05413204291
- Email: hazaloksuz@gmail.com
Study Contact Backup
- Name: tuğçe tahmaz, Phd(c)
Study Locations
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: balance games
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
|
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
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.
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.
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)
March 10, 2023
Primary Completion (Anticipated)
May 10, 2023
Study Completion (Anticipated)
July 2, 2023
Study Registration Dates
First Submitted
March 6, 2023
First Submitted That Met QC Criteria
March 7, 2023
First Posted (Actual)
March 20, 2023
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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