Clinical trial NCT06589557: Diagnostic Methods and VR Therapy for Cervical Spine Discopathy
Official title: Modern Diagnostic Methods and Evaluation of Rehabilitation Effects Using Virtual Reality (VR) Therapy for Patients With Cervical Spine Discopathy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Disability Evaluation
Recovery of Function
Keywords: Cervical Spine Discopathy
Virtual Reality Therapy
Rehabilitation
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Study Design and Group Composition:

The study will involve 100 patients with cervical spine discopathy participating in a rehabilitation program at the Provincial Hospital in Tarnów, Poland.

Eligible patients will be randomly assigned to one of two groups:

Study Group (50 patients): Participants will undergo a standard rehabilitation program supplemented with additional VR therapy aimed at improving the range of motion of the cervical spine.

Control Group (50 patients): Participants will only partake in the standard rehabilitation program.

Therapeutic Program:

Number of Therapy Sessions: Each patient will participate in a program consisting of 15 sessions (5 sessions per week for 3 weeks), with each session lasting 2 hours.

Patients in both groups will engage in the following therapies:

Manual Therapy: Techniques of mobilization and manipulation to enhance joint mobility in the cervical spine.

Proprioceptive Exercises: Exercises aimed at improving body position awareness, movement, and balance.

Individually Tailored Strengthening and Stretching Exercises: Focused on strengthening and stretching the neck muscles.

In addition, patients in the study group will participate in VR training:

VR Training: Exercises in a virtual environment designed to improve range of motion, coordination, and spatial awareness. Each VR session will last 30 minutes. Differences in outcomes between the two groups will allow for evaluating the additional impact of VR on improving cervical spine function.

Assessment Procedures:

Assessments will be conducted twice: before the therapy begins and after the rehabilitation program ends. Patients will undergo the following evaluations:

Diagnostic Measurements:

Goniometer CROM (Cervical Range of Motion): A specialized diagnostic device used for precise assessment of cervical spine range of motion in three planes: sagittal (flexion and extension), horizontal (left and right rotation), and frontal (left and right lateral bending). It uses a head attachment and magnetic collar to measure angles with 1° accuracy, crucial for precise diagnosis and treatment planning.

Zebris Device: A modern diagnostic tool combining marker technology and ultrasonic signals to comprehensively assess cervical spine mobility in all planes. Special markers on the patient's head are tracked by sensors, and the software processes this data to provide detailed information on movement ranges and directions.

VR Goggles: Used to assess cervical spine range of motion, vision, and proprioception. They create an interactive virtual environment, allowing for precise movement analysis and providing real-time feedback to the patient.

Functional Assessment Questionnaires:

Personal Data Survey: Collects basic information such as age, gender, medical history, current treatment, lifestyle, and other factors that may affect therapy.

VAS Pain Scale (Visual Analogue Scale): A tool for self-assessment of pain, where patients indicate their pain level on a line from 0 (no pain) to 10 (worst possible pain).

Neck Disability Index (NDI): Assesses the degree of disability and functional limitations through ten questions related to daily life activities.

SF-20 Quality of Life Scale: Evaluates general health and quality of life across six dimensions: physical functioning, social functioning, role limitations due to physical health, role limitations due to emotional problems, mental health, and general health perceptions.

Study Procedure:

Diagnostic Evaluation:

Assessment of the repeatability and accuracy of diagnostic devices on healthy volunteers (100) and patients with cervical spine discopathy (100), using:

Goniometer CROM for precise measurement of cervical spine range of motion. Zebris device using marker systems and ultrasonic signals to assess mobility in all cervical spine planes.

VR goggles to evaluate cervical spine range of motion, vision, and proprioception.

Patient Information: Before testing, patients will be informed about the study's purpose and procedures, including the use of Goniometer CROM, Zebris device, and VR goggles.

Patient Positioning: Assessments will be conducted in a seated position with back support, feet flat on the floor, and hands resting on thighs to maintain a stable and comfortable posture.

Test Procedure:

Cervical Spine Mobility Assessment: Using the Goniometer CROM, Zebris device, and VR goggles to measure cervical spine movement in all planes (flexion, extension, left-right rotation, and left-right lateral bending).

Vision Range Assessment: Using VR goggles, patients will track moving objects across different parts of their visual field.

Proprioception Assessment with VR Goggles: Patients will replicate movements previously measured during the test to evaluate their depth perception and spatial coordinatio

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of cervical spine range of motion using a Cervical Range of Motion (CROM) goniometer and the Zebris system.
timeFrame: First examination - before the start of the rehabilitation program;
measure: Assessment of cervical spine range of motion using a Cervical Range of Motion (CROM) goniometer and the Zebris system.
timeFrame: Second examination - at the end of the three-week program
measure: Assessment of cervical spine proprioception using virtual reality (VR) goggles.
timeFrame: First examination - before the start of the rehabilitation program;
measure: Assessment of cervical spine proprioception using virtual reality (VR) goggles.
timeFrame: Second examination - at the end of the three-week program
measure: Assessment of visual field during neck movements using virtual reality (VR) goggles.
timeFrame: First examination - before the start of the rehabilitation program;
measure: Assessment of visual field during neck movements using virtual reality (VR) goggles.
timeFrame: Second examination - at the end of the three-week program
Secondary outcomes:
measure: Assessment of pain symptoms in the cervical spine region using the Visual Analog Scale (VAS).
timeFrame: First examination - before the start of the rehabilitation program;
measure: Assessment of pain symptoms in the cervical spine region using the Visual Analog Scale (VAS).
timeFrame: Second examination - at the end of the three-week program
measure: Assessment of functional improvement in daily activities and overall functionality using the Neck Disability Index (NDI) questionnaire.
timeFrame: First examination - before the start of the rehabilitation program;
measure: Assessment of functional improvement in daily activities and overall functionality using the Neck Disability Index (NDI) questionnaire.
timeFrame: Second examination - at the end of the three-week program
measure: Quality of life assessment using the SF-20 Health Survey questionnaire.
timeFrame: First examination - before the start of the rehabilitation program;
measure: Quality of life assessment using the SF-20 Health Survey questionnaire.
timeFrame: Second examination - at the end of the three-week program
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: Andżelina Wolan-Nieroda
state: Al. Rejtana 16C
Study officials:
affiliation: University of Rzeszow
name: Andżelina Wolan-Nieroda, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rzeszow
name: Agnieszka Guzik, Professor
role: STUDY_CHAIR
References: