Clinical Research Directory

Three-Dimensional Scoliosis Exercises and Diaphragmatic Manual Techniques in Adolescents With Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine that emerges during growth and is characterized by lateral curvature, vertebral rotation, and trunk asymmetry. AIS can negatively affect not only the spinal structure but also postural control, trunk stability, muscle activation patterns, respiratory function, and the quality of life of individuals. Particularly in thoracic curvatures, decreased rib cage mobility and impaired functional effectiveness of the diaphragm and intercostal muscles can lead to reduced respiratory capacity and respiratory muscle strength. Therefore, in scoliosis rehabilitation, it is important to evaluate not only spinal alignment but also respiratory mechanics and diaphragmatic function. Currently, among conservative treatment approaches, Three-Dimensional Scoliosis Exercises (Schroth method) are widely used and reported to be effective in reducing curvature progression. However, scientific evidence regarding the effects of supporting Schroth exercises with diaphragmatic manual techniques on muscle activation, trunk derotation, and respiratory function is limited. Since the diaphragm is both a primary respiratory muscle and an important postural muscle involved in spinal stabilization, it is thought that improving diaphragmatic function may contribute to scoliosis rehabilitation. In this randomized controlled trial, 24 individuals aged 10-18 years diagnosed with AIS will be divided into two groups. The study group will receive Schroth exercises supported by diaphragmatic manual techniques, while the control group will receive only Schroth exercises. Participants will be evaluated before and after treatment in terms of superficial muscle activity, Cobb angle, trunk rotation angle, perception of cosmetic deformity, respiratory functions, respiratory muscle strength, and quality of life. The unique value of this research is that it is one of the limited number of studies that multidimensionally examine the effects of diaphragmatic manual techniques combined with Schroth exercises on electromyographic muscle activation, derotation, and respiratory functions. It is expected that the results will contribute to the development of new rehabilitation approaches in the conservative treatment of AIS, strengthen evidence-based physiotherapy practices, and improve the quality of life of individuals with scoliosis.

Feedback-Based Balance Training for Adolescents With Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is the most common form of scoliosis occurring during the growth period and is associated with significant alterations in postural balance compared with healthy peers. Prior research has shown that adding sensorimotor or balance-focused training to scoliosis-specific exercises may produce greater improvements in postural control and overall balance function than scoliosis-specific exercises alone. However, no study has previously investigated the effects of feedback-based balance training using a multi-axial platform with real-time biofeedback (the HUBER® 360 Evolution system) in this population. The aim of this study is to evaluate the effect of adding HUBER® 360-based feedback balance training to individualized conservative scoliosis exercises on postural balance, postural symmetry, and health-related quality of life in adolescents with AIS. The intervention protocol consists of 12 sessions delivered over 4 weeks, three sessions per week. Each session comprises 40 minutes of individualized conservative scoliosis exercises (identical between arms) followed by 30 minutes of balance training that differs between arms: HUBER® 360-based feedback balance training delivered in the clinic in the intervention arm, and a structured home-based balance exercise program performed independently after physiotherapist instruction in the active comparator arm. Outcomes are assessed at three time points: T0 (baseline, week 0), T1 (immediately post-intervention, week 4), and T2 (12-week follow-up, week 16 from baseline). The primary outcome is the Stability Index measured by the TecnoBody ProKin stabilometric platform. Pre-specified key secondary outcomes include mediolateral standard deviation of the center of pressure, Romberg area ratio, Limits of Stability, the Scoliosis Research Society-22 Patient Questionnaire (SRS-22) total score, and single-leg stance time. Additional exploratory outcomes include further static, dynamic, and proprioceptive balance parameters from the TecnoBody ProKin platform; postural asymmetry parameters from the DIERS Formetric 4D rasterstereography system; and SRS-22 subdomain scores.

Comparison of the Efficiency of Schroth Method and Virtual Reality Exercises in Individuals With AIS

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. The 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.

Reliability and Validity of Hand Dynamometer Trunk Muscle Strength Measurements in Patients With AIS

Adolescent idiopathic scoliosis (AIS) is a three-dimensional complex deformity of the spine characterized by lateral deviation of 10 degrees or more in the frontal plane, rotation in the transverse plane and hypokyphosis in the sagittal plane. It has been reported that in the presence of scoliosis, there is a change in muscle strength of people compared to their healthy peers due to the deterioration of their postural balance. There are many studies in the literature that evaluate the muscle strength of cases diagnosed with scoliosis with objective devices. Among these objective devices, reliability studies on hand dynamometry devices, which are easy to use, portable and cheaper than other devices, have been conducted for different populations. However, no reliability study of the handheld dynamometer device in patients with AIS has been found in the literature. Therefore, the aim of our study is to study the intra-rater and inter-rater reliability and validity of the trunk flexion, extension and lateral flexion muscle strengths of the hand dynamometer device in cases with AIS, which are known to have changes in muscle strength compared to their peers as a result of the change in spinal alignment. After obtaining the demographic information of the cases that meet the inclusion criteria within the scope of the study, the isometric muscle strength of the trunk flexor, extensor and right-left lateral flexor muscles will be evaluated by two different evaluators using a Lafayette hand dynamometer. To avoid systematic error, each participant will perform the isometric handheld dynamometer protocol in a random testing order. In order to determine interobserver reliability, on the first day of the test, the same hand dynamometer protocol will be applied to each participant by two different evaluators, after a 1-hour rest to prevent fatigue. To determine intraobserver reliability and compliance, participants will be re-evaluated by the same researchers at the same protocol, place and day period, 1 week apart to prevent learning effects. This study will reveal the intraobserver and interobserver reliability and validity of the handheld dynamometer device, which can be used in the evaluation of trunk muscle strength for clinicians working with AIS.

Scapula and Upper Extremity Performance in Scoliosis

Adolescent Idiopathic Scoliosis s a three-dimensional spinal deformity that may alter shoulder girdle alignment, scapular orientation, and upper extremity biomechanics. Changes in scapular position can influence arm movement, muscle activation, and overall functional performance. Understanding these relationships is clinically important for developing effective exercise and rehabilitation strategies. The aim of this study is to examine the association between scapular position and upper extremity performance in adolescents diagnosed with Adolescent Idiopathic Scoliosis. Scapular dyskinesis, scapular lateral displacement, and upper limb functional performance will be evaluated and correlated with Cobb angle severity. Findings may help clinicians better understand functional impairments linked to scoliosis and support more targeted rehabilitation programs.

Hypermobility, Foot Posture, and Scoliosis Severity

Adolescent Idiopathic Scoliosis is a three-dimensional spinal deformity that may also affect joint mobility, lower limb alignment, and overall posture. Joint hypermobility and foot posture abnormalities, including pronation or supination, are commonly observed in adolescents and may contribute to postural imbalance or altered biomechanical loading. However, the relationship between hypermobility, foot posture, and the severity of scoliosis remains unclear. The aim of this study is to examine whether generalized joint hypermobility and foot posture characteristics are associated with Cobb angle severity in adolescents diagnosed with Adolescent Idiopathic Scoliosis. Hypermobility will be assessed using the Beighton Score, and foot posture will be evaluated with the Foot Posture Index. Understanding these associations may help clinicians better evaluate biomechanical factors related to scoliosis and guide future preventive or therapeutic approaches.

Kids With Iron Deficiency and Scoliosis

This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery. Research Question(s)/Hypothesis(es): Primary * Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion. Secondary * Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion. * Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.

Advanced SPinal Innovations With Robotics and Enabling Technology Registry

Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.

3D Body Surface Modeling for Scoliosis Monitoring

This is a single center, prospective, non-randomized reproducibility study of the NSite device in patients undergoing evaluation for scoliosis. The NSite device is a pre-market, investigational device. The study will enroll 13 eligible patients, who will be scanned using the NSite device by 3 separate users in order to assess if the device generates similar results across users. This data will be used to support 510(k) submission.

The Effect of Core Exercises in Postoperative Scoliosis

This study aims to investigate the effects of a core stabilization-based rehabilitation program following adolescent idiopathic scoliosis (AIS) surgery on radiological parameters, pain, upper extremity function, range of motion, and scapular assessment. Participants diagnosed with AIS and treated with posterior spinal fusion surgery will undergo a rehabilitation program based on core stabilization exercises. Outcome measures will include Cobb angle, vertebral rotation, Visual Analog Scale (VAS), QuickDASH, Trunk Appearance Perception Scale (TAPS), SRS-22, cervical and shoulder range of motion, and scapular assessment tests. Assessments will be conducted before and after the rehabilitation program.

Adolescent Idiopathic Scoliosis and Body Schema

Adolescent idiopathic scoliosis is the most common form of scoliosis. Although an increasing number of studies suggest that an abnormal sensory-motor integration critically contributes to the cause of adolescent idiopathic scoliosis , there is uncertainty about the level of the central nervous system explaining this dysfunction. Therefore, the planned master's thesis study aims to compare proprioception, tactile acuity, right-left reasoning ability, motor imagery ability, including the evaluation of body schema, which is a sensorimotor representation in adolescent idiopathic scoliosis patients with healthy individuals. In addition, the relationship of these markers with posture results, body perception and quality of life of individuals with adolescent idiopathic scoliosis will be investigated as a secondary aim.

Identification of Circulating microRNAs in Adolescent Idiopathic Scoliosis

The aim of the present study is to evaluate the expression of a large panel of microRNAs, already known and validated in other ortopedic pathologies and bone metabolism, in the plasma of Adolescent Idiopathic Scoliosis (AIS) patients. The deregulated microRNAs identified will be then validated and computational analyzes will determine their potential involvement in the metabolism of bone and/or cartilage tissue in order to correlate the results obtained with the clinical data of the AIS patients. The investigators aimed to develop a microRNAs panel to further validate in a larger population of AIS patients in order to produce a device for the diagnosis and prognosis of Molecular-based AIS.

Active Video Game-Based Exercise Training and Stability Training After AIS Surgery

The purpose of this clinical trial is to investigate the effects of "Active Video-Based Exercises (AVTE) on postural control and balance in comparison with stabilization exercises is (AIS) after Posterior Spinal Fusion (PSF) surgery. Fifty-one patients with AIS after PSF surgery will be randomly divided into groups as Group I-AVTE Group, Group II-Exercise Group, Group III-Control Group, and a 12-week program will be applied. Evaluations will be performed at baseline, 12 and 24 weeks. The primary evaluations will be postural stability and balance; secondary evaluations will be pain, trunk muscle strength, mobility, endurance, core stabilization, function, quality of life, and satisfaction.

The Effect of Erector Spinae Plane Block (ESPB) on Pediatric Pain Management Following Posterior Spinal Fusion (PSF) Surgery

This study is being done to better understand the efficacy of an erector spinae plane block (ESPB) in pain management for children with Adolescent Idiopathic Scoliosis or Neuromuscular Scoliosis undergoing Posterior Spinal Fusion surgery. The study team is trying to find out if receiving the ESPB leads to less pain and less need for pain medication after surgery. The ESPB involves an injection of a local anesthetic, ropivacaine, into your child's back muscles to help block pain signals.

Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

The overall aim of the study is to utilize a novel device and smartphone application in order to improve measurement of patient compliance with at-home bracing for scoliosis as well as create a more accurate assessment of brace fit via continuous and objective measures of tension. These ground-breaking metrics will provide analyzable data to more accurately reflect and predict actual patient compliance as well as allow for further exploration of how to increase compliance, and thus, efficacy of bracing; it will additionally allow both physicians and patients to have a more reliable measure for brace fit by providing them with continuous data of fit via tension, and provide built-in feedback mechanisms to the patient to ensure proper tightness of the brace. Additionally, the study will investigate whether providing the wearer's own brace-wear compliance information directly to the patient and their caregiver(s) via the mobile app will further improve rates of compliance as compared to those who do not receive the same feedback mechanism.

Diaphragm Mobilization in Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that can affect posture, trunk movement, and respiratory function. Changes in the shape of the rib cage may influence diaphragm function and breathing mechanics in individuals with scoliosis. The Schroth Best Practice (SBP) exercise program is commonly used in the conservative treatment of scoliosis and focuses on posture correction and scoliosis-specific exercises. However, the additional benefits of manual diaphragm mobilization combined with this exercise program are not well known. The aim of this randomized controlled trial is to investigate the effect of diaphragm mobilization added to the Schroth Best Practice program in adolescents with idiopathic scoliosis. Participants will be randomly assigned to two groups: one group will perform the SBP exercise program alone, and the other group will receive SBP exercises combined with diaphragm mobilization. The intervention will be performed three times per week for six weeks. Assessments will be conducted at baseline, at the end of the 6-week intervention, and at a 12-week follow-up. Outcomes will include respiratory function measured by spirometry, trunk rotation, thoracic mobility, trunk flexibility, quality of life, and body image. The results of this study may help determine whether adding diaphragm mobilization to scoliosis-specific exercise programs improves clinical outcomes in adolescents with idiopathic scoliosis.

3D, Dynamic and Mechanically-informed Decision Making in AIS

Adolescent Idiopathic Scoliosis (AIS) is a growth defect of the spine that primarily occurs in prepubertal children between the age of 10 to 14 years, affecting approximately 3% of these otherwise normal children. AIS has been associated with problems related to posture, load-related back pain, as well as aesthetic problems, e.g. the induced asymmetry of the shoulder. Therefore, early diagnosis followed by the appropriate treatment is vital to prevent further curve progression of AIS and minimize the health-related complications of these patients. The current treatment recommendation to stop curve progression for an immature patient with a scoliosis curve between 25 and 40 degrees is to wear a brace. If the curve in the skeletally immature patient is not responding to the brace treatment, dynamic scoliosis correction by vertebral body tethering can be considered when there is still some growth potential left. State-of-the-art guidelines for the selection of fusion levels are currently mainly based on two-dimensional (2D) static radiographic parameters (such as, the Cobb angle and Shoulder balance) and a qualitative assessment of 2D bending or traction radiographs. Several classification systems and algorithms that are based on the 2D static radiographic (X-ray) parameters exist to assist surgeons in determining the appropriate levels to be instrumented. Despite this wide range of classification systems and detailed guidelines available in the literature, spinal fusion does not always yield satisfying 2D radiographic clinical outcome, with revision rates ranging from 3.9% to 22%. Overall, the surgeon is presently not provided with 3D dynamic and mechanical information regarding the deformity of the AIS to guide the decision-making. Obtaining this vital 3D dynamic information regarding the curvature and mechanical behavior of the spine will allow the surgeon to make an evidence-based and well-informed decisions in the treatment of the AIS patient. Consequently, realizing these objectives has the potential to improve patient satisfaction, reduce the postoperative complications and accordingly reduce socio-economic costs associated with AIS treatment. Recent advances in the use of subject specific musculoskeletal models will form the basis to realize this shift from 2D to 3D dynamic in AIS care.

Spine Surgery for Lenke 1 Adolescent Idiopathic Scoliosis

Idiopathic scoliosis of developmental age (AIS) is the most vertebral deformity in the adolescent population, with a prevalence of 1-3%. The treatment of AIS depends on the morphology and extent of the curve and the growth potential residual, can range from simple clinical-radiological monitoring, to the use of braces to, in the most severe cases, correction surgical correction. The indication for surgical correction of AIS depends on the location, extent and flexibility of the scoliotic curve and not least on the patient's age or, better, the skeletal age. The primary goal of surgery is to correcting the deformity by preventing its progression, preserving as many motion segments as possible; secondarily, the surgery aims to restore the coronal and sagittal balance of the spine.

Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.

Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

This study evaluates the combined effect of botulinum toxin A (administered as Dysport® (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two thirds of patients will be treated with Dysport® and bracing, while the remaining patients will be treated with placebo and bracing.

MRI-Guided Dynamic Support System for Scoliosis Correction

This prospective pilot study evaluates the feasibility and effectiveness of an MRI-guided dynamic support system (MRI-DSS) for rapid, quantitative correction of adolescent idiopathic scoliosis (AIS). The system uses MRI-compatible air padding supports and programmable pneumatic control to apply and adjust corrective forces in real time. AIS patients underwent MRI-guided bracing, with Cobb angles and biomechanical parameters measured at each pressure level.

Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents

This study is a randomised controlled trial designed to compare two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS). The main hypotheses it aims to address are as follows: * Treatment with a HIIT (High-Intensity Interval Training) type training program via tele-rehabilitation, supervised by an adapted physical activity teacher, is effective in AIS. * A 12-week physical activity program maintains this efficacy over the long term. To test this hypothesis, Two groups of adolescents will be evaluated: a first group made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a tele-rehabilitation (physical activity sessions at home supervised by a teacher in adapted physical activities by video). A second group, control, also made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a self-program at home consisting of exercises specific to their scoliosis.

Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)

The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.

Assessment of Respiratory Parameters, Aerobic Capacity and Sleep Quality in Thoracic AIS

This study aims to compare respiratory parameters -including pulmonary function and respiratory muscle strength-as well as aerobic capacity and sleep quality in individuals with thoracic adolescent idiopathic scoliosis. Participants will be categorized according to the ISST classification into T-type and TL-type curvature patterns. The study will evaluate differences between these groups using standardized clinical assessments.