Clinical Research Directory

Pre-op Exercise for AIS Surgery

The goal of this clinical trial is to determine if pre-operative scoliosis-specific exercises have a beneficial effect on the health outcomes of surgery for adolescent idiopathic scoliosis. Adolescent idiopathic scoliosis affects adolescents between the age of 10-18. The main questions this study aims to answer are: * Can pre-operative exercises help reduce curve progression prior to surgery? * Can pre-operative exercises help improve the surgery outcomes, such as a lower number of vertebrae needing fusion, increased curve correction, reduced surgery length, and shorter length of stay in the hospital? * Can a pre-operative exercise intervention result in a reduction of the cost of surgery? Researchers will compare the current standard of care (the control group) to an intervention group (with pre-op exercises) to see if pre-op exercises have an effect on these outcomes. Participants will: * visit the clinic every 3 months to complete ultrasound imaging scans and questionnaires * if given an exercise intervention, aim to complete it for roughly 30 minutes a day

Prospective Opioid-Free AIS Fusion

The purpose of this study is to compare the efficacy of a multimodal opioid-free (OF) pain management protocol with a traditional opioid-containing (OC) protocol in pediatric patients undergoing instrumented PSF for idiopathic scoliosis.

Basic Body Awareness Therapy Added to Scoliosis-Specific Exercise in Adolescents With Scoliosis

The goal of this randomised clinical trial is to evaluate whether adding Basic Body Awareness Therapy (BBAT) to scoliosis-specific exercises can improve body awareness, quality of life and scoliosis-speficic outcomes in adolescents aged 10-17 years with adolescent idiopathic scoliosis (AIS). The main questions it aims to answer are: Does the addition of BBAT to scoliosis-specific exercises lead to greater improvements in body awareness compared to scoliosis-specific exercises alone? Does adding BBAT improve trunk proprioception, scoliosis-related parameters, and health-related quality of life in adolescents with AIS? H1: Adolescents with idiopathic scoliosis who receive Basic Body Awareness Therapy in addition to scoliosis-specific exercises will demonstrate greater improvements in body awareness compared to those receiving scoliosis-specific exercises alone. H2: Adolescents receiving Basic Body Awareness Therapy in addition to scoliosis-specific exercises will demonstrate greater improvements in scoliosis-related clinical parameters compared to those receiving scoliosis-specific exercises alone. H3: Adolescents receiving Basic Body Awareness Therapy in addition to scoliosis-specific exercises will demonstrate greater improvements in both general and scoliosis-specific quality of life compared to those receiving scoliosis-specific exercises alone.

Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis

This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years.

Small Study Comparing Two Pain Medicines in Teenagers for Pain Control After Scoliosis Corrective Surgery.

The goal of this clinical trial is to evaluate whether adding low-dose ketamine to PCA morphine reduces opioid requirements after posterior spinal fusion surgery in adolescent idiopathic scoliosis patients. Selected patients aged 10-18 years undergoing elective AIS surgery at University Malaya Medical Centre will be randomised to ketamine-morphine or morphine-only PCA. The primary outcome is cumulative morphine consumption at 48 hours, with secondary outcomes including pain scores, opioid-related adverse effects, time to ambulation, and patient satisfaction. This study aligns with national priorities for safe opioid stewardship and enhanced peri-operative care in Malaysia.

Effects of Lumbar Traction Combined With 3D Exercise Therapy on Adolescent Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional spinal deformity that appears during adolescence without an identifiable underlying cause. A variety of low-risk physical therapy modalities, such as TENS, acupuncture, kinesio taping, spinal manipulation, and mobilization, have been explored in the management of scoliosis. Among these approaches, lumbar mechanical spinal traction is a commonly used non-invasive and painless intervention in physical medicine and rehabilitation settings. However, existing research on traction in AIS remains limited and generally of low methodological quality. Preliminary and observational studies have reported mixed outcomes, and the clinical effectiveness of traction appears to depend on factors such as curve characteristics, treatment dose, and integration with active rehabilitation. To date, high-quality randomized controlled evidence evaluating lumbar mechanical spinal traction as an adjunct to scoliosis-specific exercises in AIS is lacking. This study aims to investigate the combined effects of lumbar mechanical spinal traction and scoliosis-specific exercises in adolescents diagnosed with AIS. A prospective randomized controlled design will be used to assess changes in Cobb angle, posture, pain, and functional status. The findings may help clarify whether adding mechanical traction provides additional benefit beyond exercise alone in the conservative treatment of AIS.

Psychological Assessment of Scoliosis Patients Undergoing Surgical Management

Working in partnership with Montefiore-Einstein's Department of Translational Psychiatry, the investigators have designed a prospective randomized clinical trial (2:1) study for 45 Adolescent Idiopathic Scoliosis (AIS) patients, 10-19 years of age. This protocol includes a baseline assessment of mental health, pain, and function in AIS patients utilizing validated patient reported outcome (PRO) measures. The investigators will implement and test a structured perioperative psychological intervention program, based on the Aim to Decrease Anxiety and Pain Treatment (ADAPT), which was developed based on evidence-based cognitive behavioral therapy (CBT) protocols for the management of pediatric pain and childhood anxiety disorders

Feedback-Based Balance Training for Adolescents With Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is associated with impaired balance, and previous studies have shown that combining balance or hippotherapy training with scoliosis-specific exercises such as Schroth can improve postural control and quality of life. This study aims to evaluate the effect of adding HUBER® 360 neuromuscular balance training to scoliosis-specific exercises on balance outcomes in adolescents with AIS.

Personalized Prevention and Treatment Strategies for Adolescent Idiopathic Scoliosis Via a Comprehensive Health Management Platform

Spinal cord injury (SCI), leads to functional deficits and complications like neurogenic bladder and deep vein thrombosis, imposing a global annual financial burden. This trial aims to compares Jiaji electroacupuncture (JEA) and scalp electroacupuncture (SEA) in SCI rehabilitation. This randomized controlled trial (RCT) compared JEA and SEA in SCI rehabilitation.

Perioperative Steroid Dosing on the APR in AIS

The objective of this study is to perform a prospective, randomized controlled trial investigating the clinical usage of perioperative dexamethasone usage on APR activation, postoperative morphine usage, postoperative nausea, and hospital length of stay. There will be a control control and a Dexamethasone cohort. Participants will be randomized into one of the two cohorts. Patients in the control group will receive one 8mg dose of dexamethasone intraoperatively as per standard of care anesthesia protocols. Patients randomized to the dexamethasone cohort will be administered 8 mg of dexamethasone with 3 additional doses administered at 8-hour intervals following surgery for a total of 4 doses. All study activities will tale place at Egleston during the patient's planned inpatient stay for their posterior spinal fusion. This project has the potential to validate the utility of dexamethasone as a way to optimize postoperative care following PSF for AIS by minimizing the need for opioid medications and enhancing mobility and recovery.

Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis

The study aims to validate both the predictive capacity and the clinical usability of the Clinical Decision Support System (CDSS) developed within the PREPARE project (European Union Grant Agreement 101080288 PREPARE HORIZON-HLTH-2022-TOOL-12-01) for the management of idiopathic scoliosis (IS). This will be achieved through simulation-based studies.

AI-Based Digital Therapeutics vs. Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis

This randomized controlled trial (RCT) evaluates the efficacy of a novel Artificial Intelligence (AI)-based digital therapeutic system compared to traditional outpatient Schroth exercises for the treatment of Adolescent Idiopathic Scoliosis (AIS). The intervention utilizes a smartphone application with computer vision technology to perform remote, personalized posture analysis and generate adaptive exercise prescriptions. The study aims to determine if this "Human-in-the-Loop" AI model demonstrates superior clinical outcomes in controlling spinal curve progression and improving treatment adherence compared to standard conservative care over a 6-month period.

Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol

This is a prospective randomized controlled trial investigating the therapeutic effect of the Hybrid Bracing Protocol (HyBP) over the Conventional Brace in enhancing In-brace Correction (IBC) for adolescent idiopathic scoliosis(AIS).

Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis

Introduction: Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy. The development of a brace that enhances compliance while maintaining sufficient corrective force is crucial. This study aimed to develop and evaluate the effectiveness of a novel semi-rigid brace for AIS based on wearing time and correction rate. Materials and Methods: The investigators enrolled patients who met the following Scoliosis Research Society (SRS) criteria for brace treatment: (1) confirmed AIS diagnosis, (2) Risser sign ≤ 2, (3) Cobb angle between 25° and 40°, (4) age ≥ 10 years, and (5) single-curve pattern. Wearing time was objectively measured over 180 days using embedded temperature sensors. Correction rates were assessed at initiation and after 180 days or more.

Evaluation of a Chatbot-Delivered Structured Psychological Intervention for Teenagers With Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis is the most common spinal deformity in children and can significantly impact the psychological health of affected teenagers. Despite this, there are few effective psychological treatments available for this population. Cognitive and behavioral strategies show promise in addressing the challenges associated with the condition and its treatment. Chatbots could serve as an accessible and effective tool to support the psychological health of these teenagers. Using the Centre for eHealth Research and Disease Management Roadmap as a guide, a chatbot-based structured psychological intervention has been developed. This intervention incorporates cognitive and behavioral strategies and aims to improve the psychological health of teenagers with adolescent idiopathic scoliosis. The current phase involves implementing the intervention and conducting a pilot test to assess its feasibility, acceptability, and preliminary effectiveness. The study will employ a pilot randomized controlled trial design, nested with qualitative interviews. Participants will be recruited from community health organizations in Hong Kong and will be randomly assigned to either a control group or an intervention group using block randomization. The intervention group will engage with the chatbot-based structured psychological intervention for eight consecutive weeks. The control group will interact with a different generative chatbot, participating in casual conversations at a similar frequency. Quantitative assessments will be conducted at three points: baseline, immediately after the intervention, and one month after the intervention. Additionally, qualitative interviews will be held with selected participants from the intervention group at post-intervention to explore their experiences and perceptions of the intervention process.

Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis

OCTAGON trial is a randomized, double-blinded, parallel-group non-inferiority multicenter (Helsinki and Turku University Hospitals, Finland) clinical trial according to CONSORT criteria. 194 adolescents with idiopathic (major curve \> 45 degrees) or neuromuscular scoliosis (major curve \> 50 degrees) are enrolled for the OCTAGON trial comparing pooled human plasma (Octaplas, 10mL/kg, active management) vs. Plasmalyte (10 mL/kg, placebo) before incision as part of the normal intraoperative fluid therapy. Data is collected at baseline and at each follow-up until a minimum of 2-year follow-up. Outcomes Outcomes for the OCTAGON trial include 1) intraoperative blood loss (in mL, primary outcome) and the need for allogenic red blood cell infusion (percentage of patients). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection, neurologic deficit). Research questions and hypothesis Does prophylactic use of pooled human plasma decrease intraoperative blood loss in adolescents undergoing instrumented spinal fusion for scoliosis? We hypothesize that pooled human plasma will reduce intraoperative and total blood loss by 25% resulting in lower need for blood transfusion and fewer surgical site infections. Objectives To compare the effect of pooled human plasma vs. crystalloid fluids on intraoperative bleeding and total blood loss (drain output and hidden blood loss) in children undergoing posterior spinal fusion for AIS and NMS. Adverse events will be recorded and reported as minor (skin reaction) or major (severe allergic reaction, transfusion related acute lung injury, TRALI, deep surgical site infection, neurologic injury). Ethical aspects The PHP trial has been evaluated via European regulatory authority (EU CT: 2024-514857-31-00) and by Fimea (FIMEA/2024/006588). Informed consent is obtained from the parent(s). Results will be disseminated in high-quality peer-reviewed publications. The individual patient safety and high-quality management of fractures and scoliosis is a priority in this trial. The randomization can be opened at any stage of the treatment process. Based on the clinical decision the randomized treatment can be terminated and treatment provided accord-ing to clinical decision making even if results will be evaluated using the intention to treat princi-ple. Pain management will be prioritized in every clinical scenario and parental presence is always possible.

Effects of Body Awareness Therapy on Posture, Trunk Movement, Scoliosis & Body Awareness in Adolescents With Scoliosis

Adolescent idiopathic scoliosis (AIS) is a complex deformity of the spine, and its cause remains unknown. AIS can have negative physical, psychological, and social effects on an individual's health. There are two main treatment options for AIS: surgical and conservative approaches, including observation, exercise, and bracing. Scoliosis-specific exercises (SSE) refer to globally recognized, evidence-based exercise approaches. In this study, the Scientific Exercise Approach to Scoliosis (SEAS), one of the SSE methods, will be used. SEAS consists of individualized active self-correction exercises combined with functional movements. Additionally, the Basic Body Awareness Therapy (BBAT) method will also be applied. BBAT is a body-focused, comprehensive approach that incorporates slow, rhythmic movements and breath control. Both groups will attend supervised sessions in the clinic once a week, and home exercises will be assigned for the remaining days. Participants in the SEAS group will receive only SEAS treatment, while those in the BBAT group will receive both SEAS and additional BBAT exercises. The goal of this clinical study is to investigate the effects of BBAT in addition to a rehabilitation program including SSE, on posture, spatial orientation, trunk proprioception, scoliosis-specific parameters, quality of life, and body in adolescents with IS aged between 10 and 17 years. The research hypotheses for this study are as follows: H1: Basic Body Awareness Therapy has an effect on posture in adolescents with idiopathic scoliosis. H2: Basic Body Awareness Therapy has an effect on spatial orientation in adolescents with idiopathic scoliosis. H3: Basic Body Awareness Therapy has an effect on trunk proprioception in adolescents with idiopathic scoliosis. H4: Basic Body Awareness Therapy has an effect on scoliosis-specific clinical parameters in adolescents with idiopathic scoliosis. H5: Basic Body Awareness Therapy has an effect on both general and scoliosis-specific quality of life in adolescents with idiopathic scoliosis. H6: Basic Body Awareness Therapy has an effect on body awareness in adolescents with idiopathic scoliosis.

Investigation of Shoulder Position, Upper Extremity Proprioception, and Function in Adolescents With Idiopathic Scoliosis Using Braces

This study aims to investigate the effects of brace use on shoulder position, upper extremity proprioception, and upper extremity function in adolescents with idiopathic scoliosis. Participants will be assessed under both in-brace and out-brace conditions. The control group's upper extremity proprioception and upper extremity function will be assessed under out-brace condition. Shoulder position will be evaluated using a photographic method, while upper extremity proprioception (angular deviation) will be measured with the Laser Pointer-Assisted Angle Reproduction Test. Upper extremity function will be assessed through muscle strength tests, the Closed Kinetic Chain Upper Extremity Stability Test, the Medicine Ball Throw Test, the Finger-to-Nose Test, the Nellson Hand Reaction Test, and the Minnesota Manual Dexterity Test. Adolescents diagnosed with idiopathic scoliosis who have been prescribed brace treatment and have no history of spinal surgery or neurological/musculoskeletal conditions affecting upper extremity function will be included. Individuals with congenital or neuromuscular scoliosis, previous spinal surgery, neurological disorders affecting proprioception, or those unable to comply with study assessments will be excluded. This study aims to provide insights into the impact of bracing on proprioception and upper extremity function, contributing to the development of rehabilitation strategies for scoliosis management.

Effects of Expiratory Muscle Strength Training in Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis result in deterioration of core muscles and respiratory system. Core muscles provide trunk stabilization as well as responsible for respiratory system. Especially tr. abdominis, rectus abdominis, external oblic and internal oblic muscle, which are core muscles, highly active during forced expiration while diaphragm muscle also active during inspiration. Thus, expiratory muscle strength training has effect not only respiratory muscle strength but also trunk stabilization. While, effects of expiratory muscle strength training in adolesecent idiopathic scoliosis is a topic that needs to be investigated, this topic has not been investigated until today. Hence, this current study aimed to investigate the effects of expiratory muscle strength training on cobb angle, respiratory muscle strength, core stabilization, functional exercise capacity and quality of life.

Impact of Spinal Curves on Asymmetric Posture in Idiopathic Scoliosis

Asymmetric postures are often observed in patients with adolescent idiopathic scoliosis (AIS) and are partially associated with instability in sitting and standing positions, as well as with imbalances in gait kinematic parameters in cases of moderate or severe scoliosis. Based on the currently available data, no correlation has been identified between habitual postures in daily life and the presence of scoliosis. However, the asymmetry of preferred postures in relation to the morphological characteristics of the curves, and how this might contribute to the progression of the clinical condition due to prolonged uneven load distribution, has not yet been analyzed. Understanding any preferential direction in postures habitually adopted by patients with idiopathic scoliosis could provide valuable insights for the conservative management of the condition. The aim of this study is to analyze the influence of the morphological characteristics of scoliotic curves (type and laterality) in patients with juvenile and adolescent idiopathic scoliosis on the choice of preferentially maintained asymmetric postures in daily life, using a descriptive questionnaire completed by family members and caregivers, compared to a group of non-scoliotic subjects. Evaluate the effect of curve magnitude, age, sex, and Risser grade on the choice of usual asymmetric postures. Estimate the impact of prolonged maintenance of habitual asymmetric postures on the clinical progression in patients with juvenile and adolescent idiopathic scoliosis

Correlation Between the Cobb's Angle and the Forward Head Posture in Patients With Adolescent Idiopathic Scoliosis

Purpose of This study to detect if there is correlation between the Cobb's angle and the forward head posture in patients with Adolescent Idiopathic Scoliosis. And if there is correlation between the Cobb's angle and the cervical sagittal curve angle in AIS. And also if there is correlation between the Cobb's angle and deep flexors muscles endurance in AIS