Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589557
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Diagnostic Methods and VR Therapy for Cervical Spine Discopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Modern Diagnostic Methods and Evaluation of Rehabilitation Effects Using Virtual Reality VR Therapy for Patients With Cervical Spine Discopathy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 studys 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
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 patients 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 studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None