Scoliosis Clinical Trial
— RCTOfficial title:
Comparison of the Efficiency of Schroth Method and Schroth Method Based Virtual Reality Exercises in Individuals With Adolescent Idiopatic Scoliosis
Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine of unknown etiology, in the treatment of which physiotherapy-specific scoliosis-specific exercise (PSSE), corset and surgical treatment approaches are used depending on the severity of the curvature [8, 9]. The Schroth method, one of the PSSE methods, has been shown to reduce the severity of the curvature, Cobb angles and the need for surgery, especially in curvatures between 10-30 degrees, slow down the progression of the curvature, increase back muscle strength and improve respiratory functions [10-12]. In the Schroth method, mental imagery, exteroceptive, proprioceptive stimulations and mirror control, which follow motor learning principles and include internal focus, are used to increase body awareness and facilitate the individual's self-posture corrections with postural, sensorimotor and rotational breathing exercises specific to scoliosis [5, 10]. In cases that require long-term treatment, such as scoliosis, the motivation and participation of the child and adolescent population in particular decreases and negatively affects the success of treatment [1, 2]. Additionally, it has been reported in the literature that patients have difficulty in performing Schroth exercises at home and adapting the corrected posture to daily life[5]. For this reason, in order to maintain the corrected posture and make it permanent, motor learning-based approaches must be used [6]. Virtual reality rehabilitation (VR) creates an external focus on the individual, allows for a large number of repetitions, and thus encourages motor learning. It is also known that VR increases motivation, participation and exercise performance in children and adolescents[7]. When the literature was examined, no studies were found regarding VR in individuals with AIS. We think that our study will show that Schroth-based VR will be effective on spinal parameters, trunk rotation and spinal mobility parameters in cases with AIS. Our aim is to examine the effects of Schroth-based VR in comparison with Schroth exercises in cases with AIS.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | November 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | Inclusion Criteria: - Having been diagnosed with Adolescent Idiopathic Scoliosis by an orthopedic specialist - Being between the ages of 10 and 15 - Risser 0-3 stage - The Cobb angle determined on the anteroposterior radiograph should be 10-30 degrees. - Major curvature being lumbar curvature - No pulmonary or rib cage-related disease such as rib fracture, atelectasis, or asthma - Ability to understand and follow instructions - Volunteering to participate in the study Exclusion Criteria: - Using a brace - Having received any scoliosis treatment or spine surgery within the last year - The patient has any contraindications to exercise - Presence of neuromuscular, orthopedic, rheumatic diseases or vestibular problems that may affect balance, vision-related diseases or mental problems. - Another exercise or physical activity that may affect trunk muscle strength or balance - Presence of any problem that may affect walking other than scoliosis - Patients who cannot understand and follow instructions |
Country | Name | City | State |
---|---|---|---|
Turkey | Irem Kurt | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spinal Parameters | The most commonly used method to measure the size of the scoliosis curve is the Cobb angle. As a standard, measurement is made on a posteroanterior spine radiograph taken while standing. To determine the boundaries of scoliosis, a line is drawn parallel to the upper line of the vertebra with the greatest deviation. Similarly, for the lower border, a line is drawn parallel to the lowest vertebra. Vertical lines parallel to these two lines are drawn and the angle between the two lines is recorded. In our study, the Cobb angle will be measured and recorded in the sagittal and frental planes, based on the same vertebral endplates, on the spine x-ray taken at the beginning and after 24 weeks of treatment by the orthopedic and traumatology physician during the routine follow-up of the patient. | Baseline and 24th week | |
Primary | Risser Sign Evaluation | Risser sign is defined as the change of the pelvic growth plate from cartilage to bone. Gradual ossification of the growth plate on the iliac apophysis from anterolateral to posteromedial is evaluated. Evaluations will be determined by the orthopedic and traumatology physician during routine follow-ups of the patient based on x-rays. | Baseline and 24th week | |
Primary | Angle of Trunk Rotation Measurement | Trunk rotation angle will be measured with a Bunnell scoliometer. There is a metal sphere inside the scoliometer that moves between 0-30° in the water bed. Measurements will be made by placing the scoliometer vertically on the axial axis of the spine, perpendicular to the spinosus processes of the vertebra. The evaluation will be carried out standing, in a forward bending position with hands extended forward. To adjust the distance between the feet, the physiotherapist places one foot between the patient's two feet and the patient is positioned. By moving the scoliometer from the beginning of the thoracic region to the sacrum, the largest rotation angle in the major curvature will be recorded. In our study, trunk rotation angle will be measured and recorded at baseline, at week 12, and after 24 weeks of treatment. | Baseline, 12th week and 24th week | |
Primary | Spinal Mobility Evaluation | Evaluation of spinal mobility was performed with a portable, computer-aided electromechanical device (the Spinal Mouse System, Idiag, Fehraltorf, Switzerland) called "Spinal Mouse" (SM). The SM is an external, non-invasive measurement device that can evaluate spinal angles and curvatures in the frontal and sagittal planes. It has been reported that SM can be used as a reliable, fast and easy-to-use measurement method with no side effects for clinical research and patient follow-up in AIS. Measurements were made between the spinous process of the 7th cervical vertebra and the top of the anal fold (approximately the level of the sacral 3rd vertebra). Maximum right-left lateral flexion degrees in the frontal plane and maximum flexion-extension degrees in the sagittal plane will be measured and recorded. | Baseline, 12th week and 24th week | |
Secondary | Spinal proprioception assessment: | In our study, a dual inclinometer (Acumar) with an inter-individual reliability of 0.90 and an inter-test reliability of 0.85 will be used to evaluate the active repositioning sensation of the spine. Active repositioning sensation of participants' thoracic and lumbar spines; It will be measured for flexion, extension and right-left lateral flexion. In addition to these measurements in the thoracic region, right-left rotation movements will also be included in the evaluation. The absolute difference in degrees between two positions is noted as the reposition deviation value. This test is repeated 5 times for each movement. In the evaluation made before, at the 12th week and after the treatment, the average of 5 measurements will be taken and the results will be compared. The decrease in the reposition deviation value is evaluated as the improvement in the reposition feeling. | Baseline, 12th week and 24th week | |
Secondary | Trunk Isometric Muscle Strength | Evaluation of trunk flexion, extension and right-left lateral flexion isometric muscle strength will be performed with a manual muscle testing device, which is an objective, valid and reliable method. Trunk flexion evaluation will be performed in the 30-degree supine position, trunk extension in the prone position, and lateral flexion in the sitting position. | Baseline, 12th week and 24th week | |
Secondary | Trunk Muscle Endurance | Three core endurance tests created by McGill, consisting of the lateral bridge test, trunk extension test and trunk flexion test, will be evaluated. Before each test, the required test position will be explained to the participant and he/she will be asked to try the appropriate position. | Baseline, 12th week and 24th week | |
Secondary | Posterior Trunk Symmetry Index (POTSI) | POTSI is a valid and reliable objective method used in the evaluation of trunk asymmetry. The POTSI parameter is defined as the sum of six indices: three frontal plane asymmetry indices (C7, axilla folds, and waist lines) and three frontal plane height difference indices (acromions, axilla folds, and waist lines). The POTSI score is calculated by placing the indices in the formula on the patient's photograph taken from the posterior. The POTSI score, which indicates complete symmetry, is zero, and a higher score indicates increasing body asymmetry. In our study, SCODIAC (SCOliotic DIAgnostiCs) computer software program will be used to calculate POTSI. | Baseline, 12th week and 24th week | |
Secondary | Anterior Trunk Symmetry Index (ATSI) | ATSI is another valid and reliable objective method used to evaluate trunk asymmetry, and its use together with POTSI is recommended in studies. It is defined as the sum of six indices determined on the patient's anterior photograph: three frontal plane asymmetry indices (stern notch, axillary folds and waist lines) and three frontal plane height difference indices (acromions, axillary folds and waist lines). Calculation is made by placing the indices into the formula. In our study, SCODIAC (SCOliotic DIAgnostiCs) computer software program will be used to calculate ATSI. | Baseline, 12th week and 24th week | |
Secondary | Walter Reed Visual Assessment Scale (WRVAS) | It is a scale developed to evaluate the physical deformity perceived by patients with idiopathic scoliosis. A high score means high deformity. The scale can be completed by the patient, the person responsible for the patient's care, and the clinician performing the evaluation. In our study, this scale will be filled in by the patient. | Baseline, 12th week and 24th week | |
Secondary | Global Rating of Change (GRC): | GRC is used frequently in clinical research, especially in the field of the musculoskeletal system. This scale is designed to determine the extent of improvement or deterioration of the patient over time. It also indicates the effect of an intervention or the clinical course of a condition. In the GRC scale, the patient is asked to indicate the difference between his current health status and his health status before a specific point in time. The questions asked, the number of points on the scale, and the labels assigned to the scale points may vary [29]. A 7-point scale (-3: much worse, -2: worse, -1: slightly worse, 0: the same, 1: slightly better, 2: quite better, 3: much better) will be used in our study. | Baseline, 12th week and 24th week | |
Secondary | "Scoliosis Research Society Scale-22 (SRS-22)" | SRS-22 is a scoliosis-specific quality of life questionnaire with 22 questions and five subgroups. Subgroups of the survey; pain, image/appearance, function/activity, mental health and treatment satisfaction. It is defined as 0 (worst) and 5 (best) points for each question. The form will be filled out by asking patients to mark the answers that apply to them. If they do not understand the questions, the questions will be explained and the answers will be marked. | Baseline, 12th week and 24th week |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Recruiting |
NCT05944393 -
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
|
N/A | |
Recruiting |
NCT05888038 -
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
|
N/A | |
Completed |
NCT02531945 -
Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
|
N/A | |
Completed |
NCT02890654 -
Scoliosis and Quality of Life of Adolescents
|
||
Completed |
NCT02413788 -
Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
|
N/A | |
Completed |
NCT02558985 -
Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
|
||
Terminated |
NCT02134704 -
MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
|
N/A | |
Completed |
NCT02609009 -
Back Pain and Spinal Manipulation in Adolescent Scoliosis
|
N/A | |
Completed |
NCT02285621 -
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
|
N/A | |
Withdrawn |
NCT00768313 -
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
|
Phase 4 | |
Completed |
NCT00155545 -
Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients
|
Phase 1 | |
Completed |
NCT00154505 -
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
|
Phase 1 | |
Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
Completed |
NCT00273598 -
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
|
Phase 2 | |
Completed |
NCT03135665 -
Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure
|
N/A | |
Completed |
NCT06428864 -
Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis
|
||
Recruiting |
NCT04423146 -
Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
|
||
Completed |
NCT03814239 -
Blood and Fluid Management During Scoliosis Surgery
|
||
Withdrawn |
NCT02058238 -
ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
|