Diagnostic Methods and VR Therapy for Cervical Spine Discopathy

NCT06589557 | Enrolling By Invitation

• 1 other identifier: Uniwersytet Rzeszowski
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study will assess modern diagnostic methods and evaluate the rehabilitation effects of virtual reality (VR) therapy in patients with cervical spine discopathy.

Conditions

Disability Evaluation; Recovery of Function

Keywords

Cervical Spine Discopathy; Virtual Reality Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (6)

• Assessment of cervical spine range of motion using a Cervical Range of Motion (CROM) goniometer and the Zebris system.

  Assessment of cervical spine mobility in all planes (flexion, extension, lateral bending, and rotation). Unit of Measure: Range of motion measured in degrees (°), indicating the exact angles of neck movement in each direction. Measurement Tool: The Cervical Range of Motion (CROM) goniometer and Zebris device will be used to measure the exact angles of neck movement with an accuracy of 1°. These tools will evaluate cervical spine mobility across all planes of movement.

  First examination - before the start of the rehabilitation program;

• Assessment of cervical spine range of motion using a Cervical Range of Motion (CROM) goniometer and the Zebris system.

  Assessment of cervical spine mobility in all planes (flexion, extension, lateral bending, and rotation). Unit of Measure: Range of motion measured in degrees (°), indicating the exact angles of neck movement in each direction. Measurement Tool: The Cervical Range of Motion (CROM) goniometer and Zebris device will be used to measure the exact angles of neck movement with an accuracy of 1°. These tools will evaluate cervical spine mobility across all planes of movement.

  Second examination - at the end of the three-week program

• Assessment of cervical spine proprioception using virtual reality (VR) goggles.

  Assessment of deep neck sensation and the ability to perceive the position and movement of the neck. Unit of Measure: Deviation from the intended neck movement measured in degrees (°), which the patient can replicate during proprioceptive tests.Measurement Tool: Virtual Reality (VR) goggles will be the sole tool used to conduct proprioceptive tests. Patients will replicate neck movements displayed in the virtual environment, and the accuracy of these movements will be measured in degrees to assess proprioception and spatial coordination. Method: Using VR goggles to conduct proprioceptive tests, where patients replicate movements shown in the virtual environment to assess their depth perception and spatial coordination.

  First examination - before the start of the rehabilitation program;

• Assessment of cervical spine proprioception using virtual reality (VR) goggles.

  Assessment of deep neck sensation and the ability to perceive the position and movement of the neck. Unit of Measure: Deviation from the intended neck movement measured in degrees (°), which the patient can replicate during proprioceptive tests.Measurement Tool: Virtual Reality (VR) goggles will be the sole tool used to conduct proprioceptive tests. Patients will replicate neck movements displayed in the virtual environment, and the accuracy of these movements will be measured in degrees to assess proprioception and spatial coordination. Method: Using VR goggles to conduct proprioceptive tests, where patients replicate movements shown in the virtual environment to assess their depth perception and spatial coordination.

  Second examination - at the end of the three-week program

• Assessment of visual field during neck movements using virtual reality (VR) goggles.

  Measurement of the range of vision while performing neck movements, with the patient seated and looking straight ahead. Unit of Measure: Range of vision measured in degrees (°), indicating the extent to which the patient can perceive moving objects in different parts of their visual field while maintaining a forward gaze. Measurement Tool: Virtual Reality (VR) goggles will be used to track and analyze the patient's ability to follow moving objects across their visual field while sitting and looking straight ahead. The visual range will be measured in degrees to assess the field of vision during neck movements without changing the direction of the gaze.

  First examination - before the start of the rehabilitation program;

• Assessment of visual field during neck movements using virtual reality (VR) goggles.

  Measurement of the range of vision while performing neck movements, with the patient seated and looking straight ahead. Unit of Measure: Range of vision measured in degrees (°), indicating the extent to which the patient can perceive moving objects in different parts of their visual field while maintaining a forward gaze. Measurement Tool: Virtual Reality (VR) goggles will be used to track and analyze the patient's ability to follow moving objects across their visual field while sitting and looking straight ahead. The visual range will be measured in degrees to assess the field of vision during neck movements without changing the direction of the gaze

  Second examination - at the end of the three-week program

Secondary Outcomes (6)

• Assessment of pain symptoms in the cervical spine region using the Visual Analog Scale (VAS).

  First examination - before the start of the rehabilitation program;

• Assessment of pain symptoms in the cervical spine region using the Visual Analog Scale (VAS).

  Second examination - at the end of the three-week program

• Assessment of functional improvement in daily activities and overall functionality using the Neck Disability Index (NDI) questionnaire.

  First examination - before the start of the rehabilitation program;

• Assessment of functional improvement in daily activities and overall functionality using the Neck Disability Index (NDI) questionnaire.

  Second examination - at the end of the three-week program

• Quality of life assessment using the SF-20 Health Survey questionnaire.

  First examination - before the start of the rehabilitation program;

Study Arms (2)

Experimental: VR Therapy and Standard Rehabilitation

OTHER

Standard Rehabilitation supplemented with VR Therapy

Other: Virtual Reality (VR) and Standard Rehabilitation; Other: Standard Rehabilitation

Control: Standard Rehabilitation

OTHER

Control group - Standard Rehabilitation, without VR Therapy

Other: Standard Rehabilitation

Interventions

Virtual Reality (VR) and Standard Rehabilitation OTHER

VR Rehabilitation: The VR therapy includes exercises designed to improve the range of motion, coordination, and spatial awareness of the cervical spine. Each patient will complete 15 training sessions over three weeks (5 sessions per week, 2 hours per session), with an additional 30 minutes of daily VR exercises. Standard Rehabilitation Program: Manual Therapy: Mobilization and manipulation techniques are applied to enhance the mobility of the cervical spine joints. Proprioceptive Exercises: These exercises focus on improving body position awareness, movement, and balance. Strengthening and Stretching Exercises: Individually tailored exercises are provided to strengthen and stretch the neck muscles.

Experimental: VR Therapy and Standard Rehabilitation

Standard Rehabilitation OTHER

Patients in this group will participate solely in the standard rehabilitation program. Standard Rehabilitation Program: Number of Sessions: Each patient will complete 15 training sessions, held 5 times per week for 3 weeks, with each session lasting 2 hours. Program Components: Manual Therapy: Mobilization and manipulation techniques will be applied to improve the mobility of the cervical spine joints. Proprioceptive Exercises: These exercises aim to enhance body position awareness, movement control, and balance. Strengthening and Stretching Exercises: Customized exercises will be provided to strengthen and stretch the neck muscles, tailored to individual needs.

Control: Standard Rehabilitation; Experimental: VR Therapy and Standard Rehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 to 65 years.
• Diagnosed and confirmed cervical spine discopathy (ICD-10: M50) through imaging studies (X-ray, MRI).
• Presence of symptoms related to cervical spine dysfunction, such as neck pain, limited range of motion, and radiating pain to the arms.
• Informed consent to participate in the study and willingness to adhere to rehabilitation recommendations.

You may not qualify if:

• Active rheumatic diseases, cancers, advanced diabetes, cardiovascular diseases, or other conditions affecting the safety and effectiveness of rehabilitation.
• Cervical spine surgeries performed within the last 6 months.
• Cervical spine injuries, including fractures or dislocations.
• Severe mental disorders.
• Lack of informed consent to participate in the study.

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

Andżelina Wolan-Nieroda

Rzeszów, Al. Rejtana 16C, 35-310, Poland

Location

Study Officials

• Andżelina Wolan-Nieroda, PhD

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

• Agnieszka Guzik, Professor

  University of Rzeszow

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 6, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)