NCT07309627

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

November 14, 2025

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Oswestry Disability Index (ODI)

    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

    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)

    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)

    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

Study Arms (2)

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

Other: Conventional Physiotherapy

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

Other: Conventional PhysiotherapyOther: VR

Interventions

VROTHER

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)

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,

Also known as: Virtual Reality
Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar Üniversitesi

Umraniye, Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 41336211BACKGROUND
  • 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.

    PMID: 41338160BACKGROUND
  • 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.

    PMID: 41340847BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • İzel Akçe, PT,MSc

    Üsküdar Universty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 30, 2025

Study Start

November 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations