Low Back PainNCT05776992
Effect of Various Virtual Reality Exercise Individuals With Low Back Pain
A study testing Xbox virtual reality games and Biodex balance training in people with Low Back Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Xbox virtual reality games and Biodex balance training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2023to 2 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 with nonspecific chronic low back pain
Who cannot join
- Cognitive impairment
- Disc herniation
- Neurological deficit
- Respiratory problems
Trial locations and contacts
1 site in 1 country.
tuğçe tahmaz, Phd(c) contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
HAZAL genç
Istanbul, None Selected, 34353
tuğçe tahmz, phd(c)
About this study
Official title: 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.
Read the 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
- Conditions
- Low Back Pain
- Being tested
- Xbox virtual reality games, Biodex balance training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xbox virtual reality gamesDevice
X-box balance evaluation was implemented in a completely dark and isolated room specially prepared for this treatment and evaluation
Biodex balance trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| balance games | Experimental | virtual reality games Receives: Device: Xbox virtual reality games |
| balance training | Active comparator | Biodex balance training Receives: Device: Biodex balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Flamingo Static Balance Evaluation Test:
Flamingo balance test (FBT) is a test used for balance measurements in the Eurofit test battery.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start10 Mar 2023
- Primary completion10 May 2023 (estimated)
- Study completion2 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Istanbul Medipol University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prior to and following the eight-week application, evaluation was conducted
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776992
- Sponsor's protocol ID
- Virtual Reality Application
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32023423
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Virtual Reality Exercise in Nonspecific Individuals With Low Back Pain
- ClinicalTrials.gov ID
- NCT05776992
- Acronym / sponsor ID
- Virtual Reality Application
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 10 May 2023 (estimated)
- Study completion
- 2 Jul 2023 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prior to and following the eight-week application, evaluation was conducted
| Arm | Type | Receives |
|---|---|---|
| balance games | Experimental | Device: Xbox virtual reality gamesvirtual reality games |
| balance training | Active comparator | Device: Biodex balance trainingBiodex balance training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-60 with nonspecific chronic low back pain
Key exclusion criteria (4 listed)
- Cognitive impairment
- Disc herniation
- Neurological deficit
- Respiratory problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xbox virtual reality gamesX-box balance evaluation was implemented in a completely dark and isolated room specially prepared for this treatment and evaluation | Device | balance games |
| Biodex balance trainingthe 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. | Device | balance training |
Primary outcome
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.
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
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 32023423Dayanir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tuğçe tahmaz, Phd(c) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xbox virtual reality games and Biodex balance training in people with Low Back Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HAZAL genç, PhD (05413204291, hazaloksuz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analogue Scale (VAS) (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05776992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023; AzTrials last refreshed its copy on 2 Nov 2026.