Clinical Research Directory

Sleep Quality in Adolescents With Idiopathic Scoliosis

This controlled cross-sectional observational study aims to compare sleep quality between adolescents with idiopathic scoliosis and age- and sex-similar healthy controls. Participants aged 10-18 years will complete online questionnaires assessing demographic characteristics and sleep quality. Adolescents with idiopathic scoliosis will also be evaluated for scoliosis-specific quality of life, body image, Cobb angle, curve type, pain, brace use, and daily brace-wearing duration. The study will additionally investigate factors associated with sleep quality in the scoliosis group. The planned enrollment is 100 participants, including 50 adolescents with idiopathic scoliosis and 50 healthy controls.

Biopsychosocial Risk Influences on the Development and Generation of Early-Onset Chronic Pain

The purpose of the study is to discover the underlying subtypes of chronic musculoskeletal pain (muscle and joint pain) in youth. Specifically, the researchers are looking for different profiles of brain and immune system signals that affect how the body feels pain, and how these pain profiles are shaped by a person's medical history, psychology, and social environment. The goal is to develop more precise treatments for chronic pain in young people. Primary Aim: The investigators want to identify subtypes of childhood-onset chronic pain (pain lasting more than 3 months) that affects the musculoskeletal system. To do this, the study will enroll teens and young adults (ages 14-26 years) who were diagnosed with chronic pain in childhood (before the age of 18) or have a pediatric rheumatic disease or major surgery that places them at risk for developing chronic pain. The researchers will look at participants' childhood medical histories and treatments, their current pain and other symptoms, sensory tests of pain and immune system markers found in their blood. The investigators will use this information to find different clinical and neuroimmune profiles of chronic pain. They will also be able to identify the profiles of those who are at risk for chronic pain (because of a rheumatic disease or past surgery) but never develop long term pain. Secondary Aim: The study will look at how medical history, treatments, and different lifestyle factors (like sleep and physical activity), and psychosocial factors (mood, coping, social support) influence the pain experience in subgroups of chronic pain identified in the primary aim. By understanding specific behavioral and psychosocial risk and protective factors-the researchers hope to better understand why some young people develop long-lasting pain and others do not and also how better treatments can be developed for those who do have chronic pain.

Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study

This will be an open label, prospective study to determine the association between specific genotypes, epigenetics and behavioral factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic and side effect responses to perioperative opioids, chronic postoperative pain and gene expression in adolescents following major spine surgery.

The Effect of Curve Type Determined According to the Rigo Classification on Respiratory Muscle Strength, Quality of Life, and Functional Status in Individuals Diagnosed With Adolescent Idiopathic Scoliosis.

Adolescent Idiopathic Scoliosis (AIS) is a disorder that occurs between the ages of 10 and 18, with an unknown etiology, and is characterized by a three-dimensional deformity of the spine. It is often asymptomatic at onset but may progressively lead to cosmetic and functional impairments over time. The Rigo classification, which evaluates the structural characteristics of scoliosis, is a three-dimensional functional classification system that takes into account the direction of the curve and the involved spinal regions In studies conducted on individuals with AIS, a significant reduction in respiratory muscle strength (MIP-Maximum Inspiratory Pressure and MEP-Maximum Expiratory Pressure) has been observed, and this condition has been associated with thoracic rigidity and decreased physical activity . In individuals with AIS, a significant negative correlation has been reported between Cobb angle and FVC and FEV₁ values, as well as a moderate negative correlation between trunk rotation angle (ATR) and respiratory muscle strength (MIP and MEP). In light of these findings, it has been shown that as the severity of scoliosis increases, lung volumes decrease, and that scoliosis may affect respiration not only through a two-dimensional curvature angle but also through three-dimensional structural changes such as trunk rotation. Curves concentrated in the thoracic region according to the Rigo classification demonstrate more pronounced reductions in MIP and MEP values The impact of AIS on quality of life has been evaluated, and it has been reported that individuals with AIS score lower than healthy individuals in domains such as body image, pain, mental health, and function

Effect of Treatment on Activity and Muscle Function in Pediatric Patients With Scoliosis

This study will explore the relationship between skeletal muscle and physical activity in scoliosis patients to provide insight into both the etiology of scoliosis and potential ways to mitigate the potential harms of treatment.

Clinical Orthopaedic Data Bank (Acute and Chronic)

Data involving orthopaedic conditions and rehabilitation aspects of musculoskeletal and neuromuscular disorders will be collected and stored as part of the normal clinical care of patients seen in the University of Florida (UF) and Shands Orthopaedics and Sports Medicine Institute.

Virtual Reality-based Schroth Exercise Versus Traditional Schroth Exercise on Trunk Kinematics in Scoliosis

The study will be conducted to compare three-dimensional trunk kinematics (rotation, tilt, and flexion/extension) and quality of life among adolescents with idiopathic scoliosis receiving traditional Schroth physiotherapeutic scoliosis-specific exercises, Schroth exercises combined with immersive virtual reality using Meta Quest 2 (OhShape), and Schroth exercises combined with low-cost mobile virtual reality using Google Cardboard with a gaze-controlled game.

Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child

The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset scoliosis. The hypothesis of this project is that the new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications. The ASTS (for Active Scoliosis Treatment System) growing rod is a new fully implantable motorized spinal distraction device which can ensure a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

The Spinal Navigation Trial - Surgical Navigation or Free Hand Technique in Spine Surgery

The spinal navigation trial (SPINAV) is a randomized controlled trial (RCT) evaluating the use of computer-assisted navigation in surgery for spinal deformity

A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery

The aim of this clinical trial is to compare the effectiveness of two Serotonin (5- HT3) receptor antagonist, palonosetron and granisetron, administered along with dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis (IS) undergoing posterior spinal fusion (PSF) surgery under total intravenous anesthesia (TIVA). The main questions the study aims to answer are: How effective is palonosetron compared to granisetron, when both combined with dexamethasone, in preventing PONV after scoliosis surgery? Are there any differences in the need for rescue antiemetics, occurrence of adverse effects related to the study drugs, and patient satisfaction between the two treatment groups? Participants in the study will be randomly assigned to receive either palonosetron or granisetron in addition to dexamethasone as part of their anesthesia and antiemetic regimen. The incidence and/ or severity of nausea, vomiting and retching will be assessed at 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery.

Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy

The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA). All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant. The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.

Cardiorespiratory Assessment Prior to Scoliosis Surgery: a 10-year Experience at a Specialized Scoliosis Center

this study involves adult patients who underwent scoliosis surgery within the last 10 years. The aim of this study is to assess the frequency of scoliosis-related respiratory complications in patients requiring orthopedic surgery, in order to optimize the care pathway for patients with scoliosis. In this context, we use the medical data collected and generated during the treatment of scoliosis, as well as the results of tests and samples taken during your hospitalization to calculate the prevalence of respiratory and cardiac impairments associated with scoliosis

Evaluation of the Effect of Reiki on Pain After Lumbar Surgery

The goal of this clinical trial (prospective, comparative, and randomized double-blind study) is to learn if Reiki (a non-pharmacological intervention), when used alongside standard care, can treat and reduce postoperative pain in patients recovering from lumbar surgery (60 participants total, divided into two groups of 30). The main questions it aims to answer are: Does Reiki significantly reduce postoperative pain levels at day 15 (measured by a Visual Analog Scale) compared to a Sham (placebo) treatment? Does Reiki improve patient quality of life, enhance scar healing, lower daily analgesic consumption, and increase overall patient satisfaction compared to the Sham treatment? Researchers will compare Group A (30 patients receiving Reiki sessions alongside usual care) to Group B (30 patients receiving Sham/placebo sessions alongside usual care) to see if the Reiki group experiences lower pain levels, reduced need for painkillers, better healing, and higher overall satisfaction and quality of life. Participants will: * Receive standard postoperative care following their lumbar surgery. * Be randomly assigned to receive either two sessions of actual Reiki therapy or two sessions of a Sham (placebo) treatment. * Evaluate their daily pain levels using a Visual Analog Scale (EVA). * Complete follow-up assessments at specific intervals (Day 15, Day 21, and Day 30) to track pain levels, pain medication intake, scar healing (using a colorimetric scale), quality of life (via the SF-12 questionnaire), and overall satisfaction (via the Clinical Global Impression scale).

Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric Scoliosis

The Researchers want to assess the short-term safety of Anterior Vertebral Body Tethering (AVBT) in skeletally immature subjects with moderate to severe scoliosis and compare them with a fusion cohort.

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.

Psychometric Properties of the Turkish Version of the Staffordshire Adolescent Idiopathic Scoliosis Questionnaire

Patient-Reported Outcome Measures (PROMs) have gained increasing importance in scoliosis research in recent years. Although widely used instruments such as the Scoliosis Research Society-22 (SRS-22) include domains related to body image, their primary purpose is to assess overall health-related quality of life and functional outcomes. In contrast, the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis (SQAIS) was specifically developed to provide a more detailed and patient-centered evaluation of body image and perceived deformity in individuals with adolescent idiopathic scoliosis (AIS). However, a Turkish version of the questionnaire with established validity and reliability is not currently available. Therefore, the aim of the planned master's thesis is to conduct the cultural adaptation of the Staffordshire Questionnaire for Adolescent Idiopathic Scoliosis into Turkish and to evaluate its psychometric properties in adolescents with AIS. The study will involve a systematic process of linguistic translation and cross-cultural adaptation. Subsequently, the validity and reliability of the Turkish version will be assessed through analyses of internal consistency, test-retest reliability, construct validity, and criterion validity. The findings of this study are expected to provide a valid and reliable instrument for assessing body image and deformity perception among Turkish adolescents with idiopathic scoliosis, thereby contributing an important patient-centered outcome measure to both clinical practice and research.

Body Structure and Capacity Evaluation of Adults With Scoliosis

Adults with scoliosis have not been the focus of much research in physical therapy despite their prevalence being very important. Adults with idiopathic scoliosis have a reported prevalence of about 2-11%. This includes adolescents with idiopathic scoliosis who have become adults but still have a scoliosis. They do not get much treatment as the adolescent treatment focuses on preventing worsening of the curvatures and the risk of progression is significantly reduced once a person reaches skeletal maturity. Still some patients experience self-image, function and pain issues which may be amenable to treatment using specific exercises as was recently shown. With ageing population a growing number of adults with de novo degenerative scoliosis is observed. This is a spinal misalignment due to spine degeneration. Adult degenerative scoliosis with pain is thought to affect about 24% of the ageing adults. This population has not been investigated very much. Before planning conservative treatments for adults with scoliosis it would be important to describe what deficit these adults present that may be targeted by physical therapy. The objective of this study is to compare samples of patients with adults degenerative scoliosis, adult idiopathic scoliosis to matched healthy controls (for age, height and weight). Participants will complete questionnaires and a physical exam to identify which limitations they present that may be amenable to treatment with physical therapy. This information will assist planning trials to address the needs of these two neglected patient populations.

Deep Learning for Early Scoliosis Detection Using mmWave Radar Gait Data

Scoliosis is a sideways curvature of the spine that often develops during childhood and adolescence. When detected early, scoliosis can be managed effectively with non-invasive approaches such as bracing and physiotherapy, while late detection frequently leads to surgical intervention. Current screening methods rely on physical examination and X-ray imaging, which exposes children to ionizing radiation and may miss early-stage cases. This observational study investigates whether millimeter-wave (mmWave) radar, combined with deep learning (a type of artificial intelligence), can detect early signs of scoliosis by analyzing how a child walks. The radar sensor records subtle movement patterns during walking without using cameras and without producing any identifiable images, fully preserving the participant's privacy. No ionizing radiation is involved. Pediatric participants attending the orthopedic clinic for routine scoliosis evaluation are invited to walk a short distance in front of a mmWave radar sensor. The collected gait recordings are then analyzed using deep learning models, and the results are compared with the participant's standard clinical scoliosis assessment performed by a pediatric orthopedic specialist. The diagnostic performance of the deep learning model is evaluated using sensitivity, specificity, and overall accuracy. If the approach proves accurate, it could offer a radiation-free, privacy-preserving, and low-cost alternative for early scoliosis screening in schools, primary healthcare centers, and pediatric orthopedic clinics, ultimately supporting earlier diagnosis and reducing the long-term clinical burden of untreated scoliosis.

Effect of Adult Spinal Deformity Surgery on Functional Reach

Adult spinal deformity (ASD) is a common spinal condition that often impacts an individual's ability to stand and maintain an upright posture. Poor balance often limits an individual's ability to perform basic activities of daily life (ADL) and can lead to disability. Current considerations of correcting ASD to improve balance focus on the amount of sway that one exhibits during normal standing. However, current tests do not provide insight into the limits of balance during normal ADL. The goal of this research is to develop a new balance assessment that includes a functional reach test (FRT) to provide numerical data on the limits of one's ability to maintain balance. The study will include both ASD patients and matched healthy adults and will compare postural sway measures between them. Wearable motion tracking sensors and a force plate will be used to monitor body movement and changes in the center of pressure under foot during normal standing and during a FRT. Data from this study will inform spine surgeons of ASD patient's risk of balance loss in daily life and enable further research on the effects of surgical techniques to restore balance among ASD surgery patients.

Scoliosis Shared Decision Making

Analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.

Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism

Cerebral palsy is the primary cause of disability in France. It is a non-progressive condition leading to movement and posture troubles, but also to cognitive and sensory problems. Spasticity is one of the most regular consequences. It leads to a muscular failure with permanent contractions. Muscular dysfunction can generate scoliosis (in 60% of cases). Scoliosis can lead to pain, sitting difficulties (with chances of bedsores), and cardiopulmonary complications. These children often have cachexia (eating difficulties, trouble with deglutition). It leads to a weakening of their immune defenses, which favors post-operative infections, a weakening of their respiratory muscles, and circulatory difficulties with negative effects on scarring. Cachexia is a pessimistic prognosis. A back brace can be used to contain the scoliosis but never cures it. Another option for treating this affection would be surgery. Surgery is another treatment. It consists in straightening and holding the spine with metal rods, held by vertebral anchors placed at both ends of the scoliosis. Surgery is the gold standard. Surgery induces risks such as bleeding, healing complications and infection. The probability to face complications increases with malnutrition. The first hypothesis is that surgery could improve the nutrients intakes and the weight of the patient. The investigators also believe that it could improve the patient's body composition (body fat and lean mass) and their basic metabolic rate. The third hypothesis is that surgery-involved changes (nutrition enhancement, sitting improvement, decrease of respiratory work) could lead to an improvement of the patient's quality and life and respiratory functions. The SORONOUS project aim to prove the benefits of this surgery from a nutritional and from a general point of view in order to help make the surgical decision and avoid any care delay. In addition, it aim to identify and quantify the post-operative weight gain; while providing us with a better understanding of the behavior of pre-operative cachexia among these patients.

Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery

Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

Investigation of Pain Perception According to Gender in Individuals With Scoliosis

The aim of this study is to evaluate whether pain perception under spinal pressure created on a physiotherapy roller differs according to gender in individuals diagnosed with scoliosis.

Respiratory Muscles and Work of Breathing in Children

Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management. The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.