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Adolescent Idiopathic Scoliosis clinical trials

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NCT ID: NCT05969301 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Memory and Scoliosis Spinal Exercises

Start date: September 1, 2023
Phase:
Study type: Observational

This is a behavioral observational study aimed at evaluating the impact that spinal exercises exert on memory of young people. It consists of a short self-administered questionnaire which will be given to adolescents with scoliosis to complete. Relationships between young individuals' answers and health-related quality of life will be evaluated.

NCT ID: NCT05927701 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Self-perceived Health Status and Healthcare Consumption of Idiopathic Scoliosis Patients Treated More Than 20 Years Ago: How Much do Operated and Non-operated Patients Differ?

HISTORY
Start date: July 6, 2023
Phase:
Study type: Observational

Adolescent idiopathic scoliosis (AIS) is a common condition that affects millions of patients worldwide. This is characterized by a spinal deformity that leads to a deformation of the trunk, an imbalance of the shoulders and waist folds as well as the appearance of gibbosity. Posterior arthrodesis correction is a common practice surgery for the treatment of AIS after failure of medical treatment with a corset or functional rehabilitation. Surgery allows functional improvement and is indicated for curves greater than medically treated scoliosis. The objective of this international study is to have a better understanding of the long-term outcomes (> 20 years of follow-up) after treatment (surgical and non-surgical) of AIS and to compare the long-term status of the patient with AIS to the general population of the same age, sex and comorbidities. All of this information will help justify or modify the strategy, techniques and goals of early treatment in adolescence to achieve a better long-term outcome.

NCT ID: NCT05924581 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Validation of Clinical Assessment of Spinal Stiffness

Start date: June 6, 2023
Phase: N/A
Study type: Interventional

This study aims to validate and verify the reliability of the clinical measures used in the daily routine by doctors and therapists that allow assessing the spinal stiffness in all spatial planes. The secondary objective is the verification of the diagnostic accuracy of the most reliable tests in identifying the subjects at risk of failure, using as a radiographic standard the examinations performed by the patients during the treatment (data retrieved retrospectively) using as a control group those patients who did not obtain a correction of the spine curvature.

NCT ID: NCT05924347 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Early Scoliotic Changes in Children at Increased Risk for Scoliosis Development

EARLYBIRD
Start date: June 16, 2023
Phase:
Study type: Observational

Rationale: Despite several decades of research, the exact etiology of adolescent idiopathic scoliosis (AIS) remains unclear. In AIS, spine curvature begins with and progresses during the adolescent growth spurt. Previous studies are only performed on populations with already established scoliosis and normal spinal growth (of bone and IVD tissue) during adolescence has also not been defined. Growth pattern differences may exist between scoliotic and nonscoliotic subjects. Previous studies support the hypothesis that AIS is a spinal deformity that starts with decompensation in the IVD and is linked to sagittal spinal alignment. However, to understand its cause and pathogenic mechanism, the changes to the adolescent spine must be assessed longitudinally during the growth period coinciding with the period prior to and during the onset of AIS. Ideally this should include a cohort who do and do not develop AIS and their assessment must be minimally harmful, without radiation exposure. Certain populations are at increased risk for scoliosis development (i.e. girls with family members with scoliosis and 22q11.2DS patients). New imaging modalities (boneMRI, 3D spinal ultrasound) allow for non-radiographic monitoring of spinal growth.

NCT ID: NCT05919459 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Effectiveness of Acceptance and Commitment Therapy Versus Active Controls in Improving Psychological Functions of Parents and Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Systematic reviews revealed that Acceptance and Commitment Therapy (ACT) for parents had medium-to-large effect sizes in improving parental depression/anxiety (d > 0.50), dysfunctional parenting styles (ds = 0.61-0.77), and small-to-large effect sizes in improving children's behavioral and emotional problems (ds = 0.25-0.84) in children/teenagers with various chronic diseases. A recent randomized controlled trial (RCT) showed that a web-based ACT program involving a coach providing semi-structured written feedback was significantly better than waitlist controls in improving the self-reported depression, anxiety, burnout, and psychological flexibility skills in parents of children/teenagers with chronic conditions (e.g., type 1 diabetes) up to 4 months post-treatment. The investigator's RCT also found that 4 weekly sessions of group-based ACT plus asthma education was significantly better than asthma education alone in improving parental psychological function (i.e., stress, anxiety, guilt, worries, sorrow, anger, and psychological flexibility), and participants' children's asthma symptoms at 6-month follow-up. The investigator's path analysis showed that ACT improved parental psychological flexibility, which mediated the decrease in parental distress and childhood asthma symptoms. These findings support that ACT for parents not only improves parental psychological flexibility and psychological controls, but also enhances social/emotional functioning of children/teenagers with different problems (e.g., chronic pain). Given the busy schedule of schoolchildren in Hong Kong and the promising results of ACT in improving the psychosocial well-being of both parents and teenagers, providing ACT to parents of teenagers with adolescent idiopathic scoliosis (AIS) may be a "killing two birds with one stone" solution to benefit both parents and teenagers. The current study will investigate this possibility.

NCT ID: NCT05860673 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis

Start date: July 15, 2023
Phase: N/A
Study type: Interventional

This is a randomized trial with 1:1 allocation. The aim of the study is to evaluate clinical and radiographic outcomes in patients with developmental age idiopathic scoliosis treated with mini invasive scoliosis surgery (MIS) technique versus posterior spinal fusion (PSF) technique through clinical and radiographic evaluations.

NCT ID: NCT05833425 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Is Respiratory Muscle Strength, Peripheral Muscle Strength and Postural Control Affected in Scoliosis?

Start date: June 10, 2022
Phase:
Study type: Observational

The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates. Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. Children with adolescent idiopathic scoliosis have inadequate respiratory function. At the same time, these children show muscle weakness in certain parts of the body. The aim of this study is to compare young adolescents with scoliosis with their healthy peers and examine whether respiratory muscle strength, peripheral muscle strength and postural control are affected.

NCT ID: NCT05805995 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Effects of Vertebral Derotation on Pulmonary Functions

Start date: January 11, 2023
Phase: N/A
Study type: Interventional

This study was conducted to determine the physiological and mechanical effects of physical training post surgical correction of adolescent scoliosis using vertebral derotation.

NCT ID: NCT05730920 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

IV Methadone vs EXPAREL Erector Spinae Plane Blockade in Pediatric Subjects Undergoing Idiopathic Scoliosis Correction

AIMS
Start date: October 19, 2022
Phase: Phase 4
Study type: Interventional

The goal of this pilot study is to assess the feasibility of conducting a randomized controlled trial at a single institution comparing erector spinae plane blockade (ESPB) with liposomal bupivacaine (LB, Exparel) to intravenous (IV) methadone for managing pain in pediatric subjects undergoing adolescent and juvenile idiopathic scoliosis correction. Specifically, the goal is to enroll 15 subjects in each group and to complete data collection for all subjects. If this pilot study is successful, we plan to then design a larger scale study powered to compare specific outcomes between the two groups.

NCT ID: NCT05697939 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

3D Body Surface Modeling for Scoliosis Monitoring

Start date: August 26, 2020
Phase:
Study type: Observational

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.