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Adolescent Idiopathic Scoliosis clinical trials

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NCT ID: NCT05557773 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

The Effects of Core Stability Training on Balance in Children With Adolescent Idiopathic Scoliosis

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Scoliosis can be defined as a 3-dimensional deformity in which the lateral deviation and rotation of the vertebrae occur, as well as changes in the physiological curves of the spine. The gold standard criterion is that the Cobb angle, which determines the lateral deviation of the spine in the frontal plane, is greater than 10°. Postural control and balance occur as a result of the integration of many sensory information. It is thought that postural control and balance in Adolescent Idiopathic Scoliosis (AIS) patients are adversely affected by biomechanical changes in sensory input, central integration, weight transfer mechanism and the structure of the medulla spinalis. In addition to these, vestibular disorders and proprioceptive losses may have an effect on balance. Decline in balance reduces the quality of life of individuals with AIS. In addition, exercise has an important place in the treatment of individuals with AIS. In order to get more efficiency from the exercises, it is necessary to improve the balance. The aim of this study is to evaluate the changes in balance and proprioception of patients, to determine the place of balance exercises in the treatment of individuals with AIS, and to investigate the effect of core stabilization exercises on balance and proprioception in patients with AIS.

NCT ID: NCT05379127 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Comparing Use of Radiographs Versus Patient Empowerment (CURVE)

CURVE
Start date: July 17, 2022
Phase: N/A
Study type: Interventional

Objective: To evaluate the (cost-)effectiveness of a new patient-empowered follow up (FU) protocol in patients with Adolescent idiopathic Scoliosis (AIS) that is based on patient-reported outcome measures (PROMs), self-assessment tools and physical examination, which is compared to standard FU care by: 1) Effect evaluation, 2) Economic evaluation, 3) Implementation (process) evaluation. Study design: A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial [PRPT]). Study population: A total of 812 AIS patients (age 10-18 years) treated by the Dutch AIS Consortium, representing the scoliosis treatment centres in the Netherlands, will be included. Three subgroups of AIS patients are distinguished, which are monitored over two years: 1. Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264) 2. Post-brace treatment group (n=122 per arm; total n=244) 3. Post-surgery group (n=152 per arm; total n=304) Intervention: The new patient-empowered FU protocol (PE-FU) is based on PROMs, self-assessment tools and clinical assessment including physical examination. The protocol aims to detect curve progression or postoperative complications based on these patient-based and clinical parameters to substitute the need to obtain routine x-rays. X-rays will only be taken when progression or postoperative complications are suspected in the pre- and post-intervention groups based on predefined criteria. The standard FU protocol consists of routine full-spine radiographs and routine clinical evaluations.

NCT ID: NCT05152329 Recruiting - Scoliosis Clinical Trials

Investigating the Potential Psychological Impact of Early Screening and Long-term Monitoring for Adolescent Idiopathic Scoliosis Among Patients and Caregivers

Start date: February 1, 2021
Phase:
Study type: Observational

Adolescent Idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine of unknown aetiology, characterised by a lateral curvature and vertebral rotation. Its prevalence is estimated to be 2.5% in children between aged 10 and 16 in Hong Kong. Despite concerns regarding the psycho-social issues patients face at and after AIS screening, there is no study that directly address this subject. The investigator propose to conduct a prospective longitudinal study on the psycho-social impact of AIS early screening and long-term monitoring amongst patients and their caregivers. The proposed study will bridge this research gap by evaluating a cohort of newly-diagnosed patients with AIS through the school screening program and their caregivers. A mixed-methods research approach to tap into the distinct social, behavioural, emotional and parental experiential profiles will be used. Patterns across different profiles can enhance the investigator's understanding of which aspects of AIS early screening and long-term monitoring can adversely affect patients' psychological well-being. Findings will facilitate targeted approaches to address specific psycho-social impact of scoliosis and its treatment, heighten compliance to long-term monitoring and prevention of scoliosis progression, and mobilise a new clinical care model that addresses patient and clinician concerns.

NCT ID: NCT05071144 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Spine Procedures Assisted With RoboTics And Navigation

SPARTAN
Start date: December 13, 2021
Phase:
Study type: Observational [Patient Registry]

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

NCT ID: NCT04950660 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Oral Caffeine Use for Pain Management in AIS Patients After Spinal Fusion

Start date: December 11, 2019
Phase: Phase 4
Study type: Interventional

Prospective, randomized control trial To determine if oral caffeine decreases the frequency of opioid demand in children with adolescent idiopathic scoliosis after their spinal fusion surgery To compare pain scale ratings, number of requests for diazepam, average heart rate, average blood pressure, sex, age, ethnicity, post-op day of discharge, operative time, estimated intraoperative blood loss, remittance post-surgery, length of hospital stay, and segments fused during spinal fusion surgery.

NCT ID: NCT04760808 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Evaluation of Cerebrospinal Fluid Flow in Adolescent Idiopathic Scoliosis

MEDULLOSCOL
Start date: February 1, 2021
Phase:
Study type: Observational

Adolescent Idiopathic Scoliosis (AIS) is the most frequent spinal deformity in adolescence, but its etiology remains unknown. Recent publications suggest a link between ciliopathy and AIS. More specifically a modification of the cerebro-spinal fluid (CSF) flow by ciliary dysfunction could be at the origin of a scoliotic deformity. This study aims to compare the CSF flow measured by magnetic resonance imaging (MRI) in an AIS group and a control group.

NCT ID: NCT04746586 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Identification of Circulating microRNAs in Adolescent Idiopathic Scoliosis

IMIRSA
Start date: July 22, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT04568759 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

RCT-RPG
Start date: August 15, 2021
Phase: N/A
Study type: Interventional

The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.

NCT ID: NCT04441411 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients

NEMOST-AIS
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

The primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative treatment.

NCT ID: NCT04382638 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Effectiveness of Three Dimensional Correction During in Bracing in Adolescent Idiopathic Scoliosis

Start date: July 2, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to study the effectiveness of in-brace 3D scoliosis correction by comparing Rigo Chêneau orthoses (RCO) with conventional Traditional Boston-style thoracolumbosacral orthoses (TLSO) in Adolescent Idiopathic Scoliosis (AIS) patients, following Scoliosis Research Society (SRS) and The International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) recommendations for non-operative AIS management and research studies. This group of patients that reach the threshold for bracing have an intrinsic higher risk for curve progression. Hence, the proposed study will provide novel and high quality evidence to improve the efficacy of bracing in the non-operative treatment of AIS. This will contribute significantly to the betterment of public health by reducing the number of patients requiring surgical intervention. Ultimately, new evidence-based clinical practice guidelines on the most effective type of scoliosis braces will benefit children diagnosed with AIS worldwide.