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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05776992
Other study ID # Virtual Reality Application
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 10, 2023
Est. completion date July 2, 2023

Study information

Verified date March 2023
Source Istanbul Medipol University Hospital
Contact HAZAL genç, PhD
Phone 05413204291
Email hazaloksuz@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date July 2, 2023
Est. primary completion date May 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - 18-60 with nonspecific chronic low back pain Exclusion criteria from the study: - Cognitive impairment - Disc herniation - Neurological deficit - Respiratory problems

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Turkey HAZAL genç Istanbul None Selected

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Dayanir IO, Birinci T, Kaya Mutlu E, Akcetin MA, Akdemir AO. Comparison of Three Manual Therapy Techniques as Trigger Point Therapy for Chronic Nonspecific Low Back Pain: A Randomized Controlled Pilot Trial. J Altern Complement Med. 2020 Apr;26(4):291-299. doi: 10.1089/acm.2019.0435. Epub 2020 Feb 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Visual Analogue Scale (VAS) 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
Primary Y Balance Test 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
Primary Oswestry Low Back Pain Disability Questionnaire 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
Primary Algometer 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
Primary Body Awareness Questionnaire 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
Primary Flamingo Static Balance Evaluation Test: Flamingo balance test (FBT) is a test used for balance measurements in the Eurofit test battery. 6 weeks
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