Disability EvaluationNCT06589557
Diagnostic Methods and VR Therapy for Cervical Spine Discopathy
A study testing Virtual Reality (VR) and Standard Rehabilitation and Standard Rehabilitation in people with Disability Evaluation and Recovery of Function, run by University of Rzeszow at 1 site in Poland.
Trial summary
The study will assess modern diagnostic methods and evaluate the rehabilitation effects of virtual reality (VR) therapy in patients with cervical spine discopathy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Disability Evaluation, Recovery of Function
- What is being tested?
- Virtual Reality (VR) and Standard Rehabilitation and Standard Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2024to 6 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modern Diagnostic Methods and Evaluation of Rehabilitation Effects Using Virtual Reality (VR) Therapy for Patients With Cervical Spine Discopathy
The study will assess modern diagnostic methods and evaluate the rehabilitation effects of virtual reality (VR) therapy in patients with cervical spine discopathy.
Read the 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
- Being tested
- Virtual Reality (VR) and Standard Rehabilitation, Standard Rehabilitation
- Keywords
- Cervical Spine Discopathy, Virtual Reality Therapy, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) and Standard RehabilitationOther
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 RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: VR Therapy and Standard Rehabilitation | Other | Standard Rehabilitation supplemented with VR Therapy Receives: Other: Virtual Reality (VR) and Standard Rehabilitation; Other: Standard Rehabilitation |
| Control: Standard Rehabilitation | Other | Control group - Standard Rehabilitation, without VR Therapy Receives: Other: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Evaluation of pain levels in the cervical spine region. Unit of Measure: Pain intensity is measured on a scale of 0 to 10 using the Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable.
Measurement Tool: The Visual Analogue Scale (VAS) will be used to allow patients to self-report their perceived pain intensity in the cervical spine region
Measured: First examination - before the start of the rehabilitation program;
Assessment of pain symptoms in the cervical spine region using the Visual Analog Scale (VAS).
Evaluation of pain levels in the cervical spine region. Unit of Measure: Pain intensity is measured on a scale of 0 to 10 using the Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable.
Measurement Tool: The Visual Analogue Scale (VAS) will be used to allow patients to self-report their perceived pain intensity in the cervical spine region
Measured: 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.
Assessment of the impact of therapy on daily activities and functionality related to neck pain.
Unit of Measure: Functional limitations and disability levels are measured as a percentage (%) using the Neck Disability Index (NDI), where higher percentages indicate greater disability.
Measurement Tool: The NDI assesses disability and functional limitations caused by neck pain, with 10 items scored from 0 to 5, for a maximum score of 50. The score is expressed as a percentage, with higher percentages indicating more severe disability:
0-4 points (0-8%): No disability 5-14 points (10-28%): Mild disability 15-24 points (30-48%): Moderate disability 25-34 points (50-68%): Severe disability 35-50 points (70-100%): Complete disability.
Measured: 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.
Assessment of the impact of therapy on daily activities and functionality related to neck pain.
Unit of Measure: Functional limitations and disability levels are measured as a percentage (%) using the Neck Disability Index (NDI), where higher percentages indicate greater disability.
Measurement Tool: The NDI assesses disability and functional limitations caused by neck pain, with 10 items scored from 0 to 5, for a maximum score of 50. The score is expressed as a percentage, with higher percentages indicating more severe disability:
0-4 points (0-8%): No disability 5-14 points (10-28%): Mild disability 15-24 points (30-48%): Moderate disability 25-34 points (50-68%): Severe disability 35-50 points (70-100%): Complete disability.
Measured: Second examination - at the end of the three-week program
Quality of life assessment using the SF-20 Health Survey questionnaire.
Evaluation of general health and quality of life will be conducted 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.
Unit of Measure: Scores for each dimension range from 0 to 100, with higher scores indicating better functioning and quality of life.
Measurement Tool: The SF-20 Health Survey will be used to assess general health and quality of life. Each dimension is scored separately, with 0 indicating the poorest health or most severe limitations, and 100 representing the best health or no limitations. The score for each dimension is the average of the relevant questions, providing a detailed profile of the individual's health across each dimension, without a total combined score.
Measured: First examination - before the start of the rehabilitation program;
Quality of life assessment using the SF-20 Health Survey questionnaire.
Evaluation of general health and quality of life will be conducted 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.
Unit of Measure: Scores for each dimension range from 0 to 100, with higher scores indicating better functioning and quality of life.
Measurement Tool: The SF-20 Health Survey will be used to assess general health and quality of life. Each dimension is scored separately, with 0 indicating the poorest health or most severe limitations, and 100 representing the best health or no limitations. The score for each dimension is the average of the relevant questions, providing a detailed profile of the individual's health across each dimension, without a total combined score.
Measured: Second examination - at the end of the three-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion6 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andżelina Wolan-Nieroda, University of Rzeszow
- Investigators
- Andżelina Wolan-Nieroda, PhD, Principal investigator, University of RzeszowAgnieszka Guzik, Professor, Study chair, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589557
- Sponsor's protocol ID
- Uniwersytet Rzeszowski
- Status last verified
- Sep 2024
- First submitted
- 21 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modern Diagnostic Methods and Evaluation of Rehabilitation Effects Using Virtual Reality (VR) Therapy for Patients With Cervical Spine Discopathy
- ClinicalTrials.gov ID
- NCT06589557
- Acronym / sponsor ID
- Uniwersytet Rzeszowski
- Conditions
- Disability Evaluation, Recovery of Function
- Keywords
- Cervical Spine Discopathy, Virtual Reality Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 6 May 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: VR Therapy and Standard Rehabilitation | Other | Other: Virtual Reality (VR) and Standard Rehabilitation, Other: Standard RehabilitationStandard Rehabilitation supplemented with VR Therapy |
| Control: Standard Rehabilitation | Other | Other: Standard RehabilitationControl group - Standard Rehabilitation, without VR Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality (VR) and Standard RehabilitationVR 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. | Other | Experimental: VR Therapy and Standard Rehabilitation |
| Standard RehabilitationPatients 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. | Other | Control: Standard Rehabilitation, Experimental: VR Therapy and Standard Rehabilitation |
Primary outcome
Assessment of cervical spine range of motion using a Cervical Range of Motion (CROM) goniometer and the Zebris system.
Time frame: First examination - before the start of the rehabilitation program;
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.
Assessment of cervical spine range of motion using a Cervical Range of Motion (CROM) goniometer and the Zebris system.
Time frame: Second examination - at the end of the three-week program
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.
Assessment of cervical spine proprioception using virtual reality (VR) goggles.
Time frame: First examination - before the start of the rehabilitation program;
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.
Assessment of cervical spine proprioception using virtual reality (VR) goggles.
Time frame: Second examination - at the end of the three-week program
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.
Assessment of visual field during neck movements using virtual reality (VR) goggles.
Time frame: First examination - before the start of the rehabilitation program;
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.
Assessment of visual field during neck movements using virtual reality (VR) goggles.
Time frame: Second examination - at the end of the three-week program
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
6 secondary outcomes
Assessment of pain symptoms in the cervical spine region using the Visual Analog Scale (VAS).
Time frame: First examination - before the start of the rehabilitation program;
Assessment of pain symptoms in the cervical spine region using the Visual Analog Scale (VAS).
Time frame: 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.
Time frame: 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.
Time frame: Second examination - at the end of the three-week program
Quality of life assessment using the SF-20 Health Survey questionnaire.
Time frame: First examination - before the start of the rehabilitation program;
Quality of life assessment using the SF-20 Health Survey questionnaire.
Time frame: Second examination - at the end of the three-week program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Disability Evaluation
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Not yet recruitingObservational study
A Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status.
Scleroderma
Active, not recruitingObservational study
Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients
Multiple Sclerosis
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andżelina Wolan-Nieroda, PhD principal investigator
University of Rzeszow
Agnieszka Guzik, Professor study chair
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) and Standard Rehabilitation and Standard Rehabilitation in people with Disability Evaluation and Recovery of Function, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of cervical spine range of motion using a Cervical Range of Motion (CROM) goniometer and the Zebris system. (time frame: First examination - before the start of the rehabilitation program;). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.