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Effect of Various Virtual Reality Exercise Individuals With Low Back Pain

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Xbox virtual reality games
Biodex balance training
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-60 with nonspecific chronic low back pain Exclusion criteria from the study: Cognitive impairment Disc herniation Neurological deficit Respiratory problems

Sites / Locations

  • HAZAL gençRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

balance games

balance training

Arm Description

virtual reality games

Biodex balance training

Outcomes

Primary Outcome Measures

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.
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
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.
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.
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.
Flamingo Static Balance Evaluation Test:
Flamingo balance test (FBT) is a test used for balance measurements in the Eurofit test battery.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2023
Last Updated
March 21, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05776992
Brief Title
Effect of Various Virtual Reality Exercise Individuals With Low Back Pain
Official Title
Effect of Different Virtual Reality Exercise in Nonspecific Individuals With Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
May 10, 2023 (Anticipated)
Study Completion Date
July 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prior to and following the eight-week application, evaluation was conducted
Masking
Investigator
Masking Description
Treatment and assessment in the study was performed by different physiotherapists.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
balance games
Arm Type
Experimental
Arm Description
virtual reality games
Arm Title
balance training
Arm Type
Active Comparator
Arm Description
Biodex balance training
Intervention Type
Device
Intervention Name(s)
Xbox virtual reality games
Intervention Description
X-box balance evaluation was implemented in a completely dark and isolated room specially prepared for this treatment and evaluation
Intervention Type
Device
Intervention Name(s)
Biodex balance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Visual Analogue Scale (VAS)
Description
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.
Time Frame
6 weeks
Title
Y Balance Test
Description
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
Time Frame
6 weeks
Title
Oswestry Low Back Pain Disability Questionnaire
Description
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.
Time Frame
6 weeks
Title
Algometer
Description
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.
Time Frame
6 weeks
Title
Body Awareness Questionnaire
Description
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.
Time Frame
6 weeks
Title
Flamingo Static Balance Evaluation Test:
Description
Flamingo balance test (FBT) is a test used for balance measurements in the Eurofit test battery.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-60 with nonspecific chronic low back pain Exclusion criteria from the study: Cognitive impairment Disc herniation Neurological deficit Respiratory problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HAZAL genç, PhD
Phone
05413204291
Email
hazaloksuz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
tuğçe tahmaz, Phd(c)
Facility Information:
Facility Name
HAZAL genç
City
Istanbul
State/Province
None Selected
ZIP/Postal Code
34353
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tuğçe tahmz, phd(c)

12. IPD Sharing Statement

Citations:
PubMed Identifier
32023423
Citation
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.
Results Reference
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Effect of Various Virtual Reality Exercise Individuals With Low Back Pain

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