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Scoliosis clinical trials

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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: NCT05723952 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis, Thoracic Region

Effect of Barcelona School and Schroth for Adolescent Idiopathic Scoliosis.

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

for adolescent idiopathic scoliosis child, investigator will use Barcelona scoliosis physical therapy school and International scoliosis schroth therapy to see which school is better in dealing with scoliosis.

NCT ID: NCT05723289 Recruiting - Scoliosis Clinical Trials

Evaluation of the Feasibility of Remote Monitoring of Mechanical In-exsufflation Devices in Paralytic and Neuromuscular Patients Treated at Home.

TELE-INEX
Start date: June 2023
Phase:
Study type: Observational

The implementation of an mechanical in-exsufflator device (MI-E) requires specific expertise because it is a complex device that requires fine-tuning of the settings according to different clinical situations to optimize its effectiveness. Generally, it is performed by experienced physiotherapists in neuromuscular disease reference centers or directly at home via medical-technical home care providers. Treatment data is recorded by the machine at each MI-E session, which may be daily or less frequent, depending on the patient's dependency. All of this information can be accessed by manually downloading the data from the SD card that comes with each MI-E machine. Therefore, the retrieval of this information systematically requires the visit of staff to the patient's home. To date, compliance with these devices is not regularly measured since there is no means of telecommunication allowing remote monitoring of these therapies, whereas technological development in the field of remote monitoring has allowed remote monitoring of patients with sleep apnea syndrome treated with continuous positive airway pressure (CPAP) and, more recently, of some patients with chronic respiratory insufficiency treated with invasive ventilation (NIV). These developments are transforming on the one hand the follow-up of patients under NIV at home by the medical and paramedical teams and on the other hand the financial coverage by the health insurance organizations (ETAPES programs). Within the framework of NIV therapy, we think that remote monitoring of the quality of the sessions, i.e. measurement of peak expiratory flow, insufflated volumes, frequency and duration of the sessions, could facilitate and improve the follow-up of these patients for the medical-technical providers, the expert physiotherapists and the doctors of the reference centers. It is still too early to assume the extent to which data from remote monitoring of MI-E devices would improve patient follow-up. Nevertheless, given the increasing number of devices installed over the past several years, it is likely that the issue of telemonitoring will become a central issue. Thus, in this observational trial, we propose to evaluate the feasibility of a simple system of remote monitoring of MI-E devices in non-therapy-naive patients, with the objective of assessing the barriers and limitations of remote monitoring in this population. Primary aim is to evaluate the feasibility of remote monitoring of data from the MI-E device used in the patient's home in neuromuscular diseases. Patients will be identified by the investigators using the AGIR à dom software package (medical-technical follow-up file). If the patient accepts, the information and no-objection form will be sent to them electronically or by mail following this call, and at least 3 days before their scheduled appointment. During the patient's usual follow-up visit, if the patient does not object to participating in the study, AGIR staff in dom will install the device. This visit will take place in the patient's home. During this visit, a SanDisk (SD) Eye-Fi SDHC 4GB + WiFi Class4 memory card will be inserted into the port provided, in place of the memory card already present in the MI-E device. Then a Raspberry Pi 4 Model B will be placed in the room where the MI-E device is normally used by the patient, and connected to a power source (accessible electrical outlet in the room). The wifi SD card, which uses the device's power supply, will communicate with the Raspberry Pi via the wifi network and upload the recorded data each time the MI-E device is used. After 90 days, a routine recovery visit will be scheduled. AGIR à dom staff will replace the wifi SD card installed during the D0 visit with the standard SD card originally provided with the MI-E device. The data locally on the SD Wifi card will then be downloaded for analysis and comparison with the data being uploaded

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.

NCT ID: NCT05637723 Recruiting - Scoliosis Clinical Trials

The Effect of Schroth Exercises on Pelvic Floor Muscles

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

The aim of this study is to evaluate the effect of Schroth exercise training and Traditional Scoliosis exercise training applied 3 days a week for 6 weeks in people with Adolescent Idiopathic Scoliosis on the pelvic floor muscles and to compare these results with the control group, to evaluate pelvic asymmetry, pain, posture, body awareness, flexibility and life expectancy. It will be planned as a prospective randomized controlled trial to evaluate the correlation between 3 groups on the quality of life.

NCT ID: NCT05636280 Recruiting - Clinical trials for Scoliosis Idiopathic

The Effect of Schroth Exercises on Abdominal Muscle Thickness

Start date: January 25, 2023
Phase: N/A
Study type: Interventional

Although abdominal muscle thickness has been evaluated in individuals with scoliosis in the literature, there is no study in the literature reporting the relationship between abdominal muscle thickness under ultrasound as a result of schroth exercises. The aim of this study is to evaluate the effectiveness of the Schroth method on abdominal muscle thickness in people with AIS.

NCT ID: NCT05598021 Recruiting - Clinical trials for Scoliosis; Adolescence

Self-correction Evaluation in Scoliosis Patients

Start date: December 5, 2022
Phase:
Study type: Observational

To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis. The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction. Part 1: Retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis. Both measurements were performed in a single session. Part 2: Retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3D ultrasound instrumentation (Scolioscan, Telefeld, Hong Kong).

NCT ID: NCT05575596 Recruiting - Clinical trials for Idiopathic Scoliosis

Influence of Social Deprivation and Remoteness on Quality of Life in Adolescent's Surgical Scoliosis

Start date: November 14, 2022
Phase:
Study type: Observational

The incidence of idiopathic scoliosis is 3% or approximatively 300,000 new cases per year in France. It is estimated that between 0.1 and 0.3% of patients will eventually require surgical management, between 500 and 1000 scoliosis are operated per year in France. To our knowledge, the impact of socio-economic and territorial inequalities on the quality of life before and after surgery of idiopathic scoliosis has not been studied previously. Main objective: -Assess the impact of socio-economic and territorial inequalities on the pre- and post-operative quality of life at 1 year after surgical idiopathic scoliosis management, in a French pediatric surgery multicenter cohort. Secondary objective: - Assess the impact of socio-economic and territorial inequalities on the quality of life pre and postoperative at 3 months after surgery on a French multicenter cohort. - To assess the impact of severity and type of scoliosis on pre- and post-operative quality of life at 3 months and 1 year after surgery on a French multicenter cohort.

NCT ID: NCT05561725 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis (AIS)

Perioperative Steroid Dosing on the APR in AIS

Start date: January 3, 2023
Phase: Phase 4
Study type: Interventional

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.

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.