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Clinical Trials/NCT07309627
NCT07309627
Completed
Not Applicable

Effect of Virtual Reality-Based Rehabilitation on Balance, Pain, Kinesiophobia, Depression, and Quality of Life in Individuals With Lumbar Disc Herniation

Uskudar University2 sites in 1 country93 target enrollmentStarted: November 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Uskudar University
Enrollment
93
Locations
2
Primary Endpoint
Oswestry Disability Index (ODI)

Overview

Brief Summary

This study aims to evaluate the effects of incorporating virtual reality (VR) therapy into routine physical therapy (RPT) on balance, pain, kinesiophobia, quality of life, and depression in individuals diagnosed with lumbar disc herniation (LDH).

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Control Group

Active Comparator

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

Intervention: Conventional Physiotherapy (Other)

Experimental Group

Experimental

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

Intervention: Conventional Physiotherapy (Other)

Experimental Group

Experimental

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

Intervention: VR (Other)

Outcomes

Primary Outcomes

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

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.

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Uskudar University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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