Diagnostic Methods and VR Therapy for Cervical Spine Discopathy

NCT ID: NCT06589557

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-05-06

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

Conditions

Disability Evaluation; Recovery of Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental: VR Therapy and Standard Rehabilitation

Standard Rehabilitation supplemented with VR Therapy

Group Type: OTHER

Virtual Reality (VR) and Standard Rehabilitation

Intervention Type: 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.

Standard Rehabilitation

Intervention Type: 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

Control group - Standard Rehabilitation, without VR Therapy

Group Type: OTHER

Standard Rehabilitation

Intervention Type: 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.

Interventions

Virtual Reality (VR) and Standard Rehabilitation

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.

Intervention Type: OTHER

Standard Rehabilitation

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rzeszow

OTHER

Sponsor Role: lead

Responsible Party

Andżelina Wolan-Nieroda

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andżelina Wolan-Nieroda, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rzeszow

Agnieszka Guzik, Professor

Role: STUDY_CHAIR

University of Rzeszow

Locations

Andżelina Wolan-Nieroda

Rzeszów, Al. Rejtana 16C, Poland

Countries

Poland

Other Identifiers

Uniwersytet Rzeszowski

Identifier Type: -

Identifier Source: org_study_id