- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07309627
VR Therapy Effects in Lumbar Disc Herniation
Effect of Virtual Reality-Based Rehabilitation on Balance, Pain, Kinesiophobia, Depression, and Quality of Life in Individuals With Lumbar Disc Herniation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose:
The purpose of this study is to evaluate the effects of adding virtual reality (VR) therapy to routine physical therapy (RPT) on balance, pain, kinesiophobia, quality of life, and depression in individuals with lumbar disc herniation (LDH).
Methods:
A total of 93 patients diagnosed with LDH will be randomly assigned into two groups: an intervention group (n=47) and a control group (n=46). Both groups will undergo a conventional physical therapy program consisting of transcutaneous electrical nerve stimulation (TENS), vacuum interference, heat application, and ultrasound therapy. In addition to the conventional program, the intervention group will receive VR-based therapy.
Participants will be assessed at baseline and at the end of the intervention period using the following outcome measures: balance assessed by the Nintendo Balance Board-based Balance System; activities of daily living assessed by the Oswestry Disability Index; back pain intensity assessed by the Visual Analog Scale; kinesiophobia assessed by the Tampa Kinesiophobia Scale; quality of life assessed by the Short Form-36 questionnaire; and depression assessed by the Beck Depression Inventory.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Umraniye, Istanbul, Turkey (Türkiye), 34000
- Üsküdar Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Diagnosis of lumbar disc herniation (LDH)
- Sedentary lifestyle
- Presence of low back pain for at least 3 months
- No participation in physiotherapy or structured rehabilitation programs within the previous 6 months
Exclusion Criteria:
Exclusion Criteria
- History of spinal surgery or spinal trauma
- Presence of vestibular disorders
- Presence of neurological diseases
- Presence of cardiopulmonary diseases
- Presence of other musculoskeletal disorders affecting participation
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Arm 1 - Control Group Arm Title: Control Group Arm Type: Active Comparator Description: Participants in this group will receive standard physiotherapy interventions commonly used for the management of lumbar disc herniation. Intervention Intervention Name: Conventional Physiotherapy Intervention Type: Behavioral Intervention Description: A traditional physiotherapy program including supervised stretching, strengthening, and mobility exercises tailored for individuals with lumbar disc herniation. Assigned Arm: Control Group |
TENS, superficial and deep heat therapy, and interferential current + strengthening, stretching, and postural correction exercises Three times per week for six weeks, each session lasting 40 minutes,
Other Names:
|
|
Experimental: Experimental Group
Arm 2 - Experimental Group Arm Title: Experimental Group Arm Type: Experimental Description: Participants in this group will receive a virtual reality-based exercise program designed to improve balance, reduce pain, decrease kinesiophobia, and enhance quality of life. Intervention Intervention Name: Virtual Reality Exercise Program Intervention Type: Behavioral Intervention Description: A structured virtual reality-based exercise protocol including balance, core-strengthening, mobility tasks, and functional training tailored for lumbar disc herniation. Assigned Arm: Experimental Group |
TENS, superficial and deep heat therapy, and interferential current + strengthening, stretching, and postural correction exercises Three times per week for six weeks, each session lasting 40 minutes,
Other Names:
The Virtual Reality (VR) group : conventional treatment in combination with a VR application (Balance System Assessment System and Active Video Games), (consisting of six different games at three difficulty levels (beginner, intermediate, advanced). Each game lasted for 2 minutes and was repeated twice. Over six weeks, both groups completed a total of 18 sessions (3 sessions per week) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Disability Index (ODI)
Time Frame: 8 weeks
|
The ODI is a 10-item questionnaire developed to assess functional impairment in individuals with back pain.
It evaluates changes in self-care, lifting, walking, sitting, standing, sleeping, social life, travel, and pain.
Each item is scored from 0 to 5, with the total score ranging from 0 to 50.
The total score is then multiplied by 2 and expressed as a percentage, with higher scores indicating greater disability
|
8 weeks
|
|
SF-36 Quality of Life Scale
Time Frame: 8 weeks
|
The SF-36 assesses quality of life across eight domains: physical functioning, bodily pain, general health perception, vitality, mental health, social functioning, and physical and emotional roles.
Its validity and reliability in Turkey were established by Pınar et al.
|
8 weeks
|
|
Tampa Kinesiophobia Scale (TSK)
Time Frame: 8 weeks
|
The TSK is a 17-item self-report questionnaire using a 4-point Likert scale to assess fear of movement and/or reinjury.
Total scores are calculated by reverse-scoring items 4, 8, 12, and 16, with possible scores ranging from 17 to 68.
Scores of 37 or higher indicate a high level of kinesiophobia
|
8 weeks
|
|
Beck Depression Inventory (BDI)
Time Frame: 8 weeks
|
The Beck Depression Inventory (BDI) is a 21-item self-report Likert-type scale used to determine the frequency of depressive symptoms.
Items are scored from 0 to 3, and the scale's validity and reliability in Turkey were established by Ulusoy et al.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: İzel Akçe, PT,MSc, Üsküdar Universty
Publications and helpful links
General Publications
- Arias LFG, Zhang Y, Tijssen M, Wilhelm E. Virtual Reality Supported Neck Stretching Exercises to Improve Cervical Range of Motion. Annu Int Conf IEEE Eng Med Biol Soc. 2025 Jul;2025:1-7. doi: 10.1109/EMBC58623.2025.11253550.
- Dutta A, Hatjipanagioti K, Newsham MA, Leyland L, Rickson L, Buchanan A, Farkhatdinov I, Twamley J, Das A. Extended Reality Biofeedback for Functional Upper Limb Weakness: Mixed Methods Usability Evaluation. JMIR XR Spat Comput. 2025 Jun 3;2:e68580. doi: 10.2196/68580. eCollection 2025.
- Yuenyongchaiwat K, Chitjamnogchai C, Sermsinsaithong N, Tavonudomgit W, Mahawong L, Buranapuntalug S, Songsorn P, Thanawattano C. Benefit of home-based virtual reality aerobic exercise combined with resistance training for reversing sarcopenia and reducing depression in community-dwelling older adults with sarcopenia: a randomized control trial. Arch Gerontol Geriatr. 2026 Mar;142:106108. doi: 10.1016/j.archger.2025.106108. Epub 2025 Nov 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- deniz 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Lumbar Disc Herniation
-
Shanghai General Hospital, Shanghai Jiao Tong University...RecruitingLumbar Disc Herniation | Lumbar Disc DegenerationChina
-
Shin Kong Wu Ho-Su Memorial HospitalTerminatedLumbar Disc Herniation | Lumbar Traction | Spinal Manipulation | Lumbar SurgeryTaiwan
-
Intrinsic TherapeuticsActive, not recruitingLumbar Disc Herniation | Annular Disc Tear | Annular Tear of Lumbar DiscBelgium, Germany
-
Allina Health SystemTwin Cities Spine CenterSuspendedLumbar Disc Herniation | Lumbar Spinal Stenosis | Lumbar Spondylolisthesis | Lumbar Disc DiseaseUnited States
-
Holger JoswigCompletedLumbar Disc Herniation | Cervical Disc HerniationSwitzerland
-
Ankara Etlik City HospitalRecruitingMechanical Ventilation | Lumbar Disc Herniation SurgeryTurkey (Türkiye)
-
Medtronic Spinal and BiologicsCompletedDegenerative Disc Disease, Lumbar | Disc Herniation, LumbarCzech Republic, Slovakia, Venezuela
-
Akdeniz UniversityCompletedLumbar Disc Herniation | Lumbar Spine SurgeryTurkey
-
Firat UniversityRecruiting
-
Ramathibodi HospitalNot yet recruitingLumbar Disc Herniation
Clinical Trials on Conventional Physiotherapy
-
Istanbul Demiroglu Bilim UniversityCompletedMuscle Weakness | Rehabilitation | Intensive Care Unit SyndromeTurkey
-
University of SalamancaCompleted
-
Pamukkale UniversityCompletedChronic Low-back PainTurkey
-
Kirsehir Ahi Evran UniversitesiEnrolling by invitation
-
University of LahoreRecruitingHypotonic Cerebral PalsyPakistan
-
Eastern Mediterranean UniversityCompletedCervical SpondylosisCyprus
-
International Hellenic UniversityRecruiting
-
Kutahya Health Sciences UniversityRecruitingAnterior Cruciate Ligament InjuriesTurkey
-
Bezmialem Vakif UniversityCompleted
-
Riphah International UniversityRecruitingLateral EpicondylitisPakistan