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NCT ID: NCT03929042 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Evaluating the Effectiveness of Posture Correction Girdle for Adolescents With Early Scoliosis

Start date: July 17, 2017
Phase: N/A
Study type: Interventional

Through the ITF-Tier 3 project (ITS/ 237/ 11), a prototype of the posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses has been developed for preteen and teenage girls aged 10 to 13 who have the early stages of scoliosis. The girdle provides a corrective force onto the torso by the warping and elastic extension of the shoulder straps and waistband and the insertion of semi-rigid EVA padding and uses a point-pressure support system to achieve the target of posture improvement and spinal progression control with physical and psychological comfort. In order to evaluate the effectiveness of the posture correction girdle, it is proposed to recruit 10 patients to take low dose x-ray (sterEOS) at QMH at supine position. Then, the patient should wear the girdle for two hours and take another x-ray at standing position. If the Cobb's angle of the patient on girdle at standing position can be same as her supine position. It can prove the effectiveness of the girdle.

NCT ID: NCT03915106 Recruiting - Quality of Life Clinical Trials

Quality of Life (HRQoL) of AIS Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire

QolAISSRS22
Start date: July 1, 2019
Phase:
Study type: Observational

Adolescent Idiopathic Scoliosis (AIS) is an unexpected curvature of spine at teenage. AIS causes mainly unpleasant appearance, and sometime comes with pain and difficult to locate or move around. When the spinal curve, or "Cobb angle", increases with time, the investigators call it severe condition when the Cobb angle is 60 degrees or above. The severe suffering patients need to be operated to correct their spinal curve by using metallic rods and metallic screws (implants) to fix the spine. In order to avoid this surgery, the investigators use "brace", a hard fitting case, trying to control the spinal curve degree by using forces from outside. (bracing) to intervene the spinal curve progression is highly recommended for patients with particular clinical characteristics. However, bracing is not always a present experience apart from function restriction. Clinical recommendation requires the patients to brace over 20 hours everyday, which means the patients have to be "braced" around the clock. Patients' perception on being "braced" all day, apart from discomforts under bracing, self-image and mental health after bracing are also important psycho-social factors which have yet to be addressed. Based on our clinical experience, 1-2% of AIS patients, undergoing bracing or not (i.e. at observation stage), require surgical intervention due to rapid spinal progression in a short period of time. By definition, surgery will be arranged for patients with major spinal curve ≥50. The use of health-related-quality-of-life (HRQoL) questionnaires allow clinical professionals to explore many different kinds of interests on patients, including the patient's feeling on his/her medical condition and satisfaction with provided care. Scoliosis Research Society (SRS) patient outcome tool has been a well-accepted HRQoL questionnaire to look for the perception of patients with spinal problems of their status. The SRS-22 questionnaire that has been well accepted as its trustworthy on the score results and SRS-22 is good to be used in patients under different conditions across the disease. This is very important to obtain and compare the scores over time in order to look for any consistent changes. Apart from AIS patients requiring bracing, surgical cases are also very important group of patients to monitor their quality of life before and after surgery, and every follow-up visit after surgery.

NCT ID: NCT03904914 Recruiting - Clinical trials for Scoliosis; Adolescence

Thumb Ossification Composite Index (TOCI) to Predict Skeletal Maturity and Curve Progression in AIS

TOCI
Start date: September 1, 2016
Phase:
Study type: Observational

Accurate skeletal maturity assessment is important for prediction of curve progression and clinical management of adolescent idiopathic scoliosis (AIS) including bracing decision and counseling for prognosis. Determination of the timing of peak growth height velocity and growth remaining are paramount important.1,2 Commonly used clinical or radiological methods are still inadequate or too complex for rapid clinical use in the outpatient setting.3-5 Risser sign had disadvantages of low visibility in posteroanterior (PA) spinal radiograph, wide variability with maturity level and imprecise representation of peak height velocity (PHV) timing.6 Greulich and Pyle atlas (GP atlas) and Tanner-Whitehouse-III (TWIII) method are more reliable and comprehensive classifications to predict maturity, but they are cumbersome and time consuming to be used clinically.7 Both methods require the usage of an atlas, a learning curve required for exact matching of atlas plate or assignment of scores to bones.8 In this study, the investigators introduce Thumb Ossification Classification Index (TOCI). TOCI employed the measurements of epiphysis of distal phalange, proximal phalange, and adductor sesamoid, and results were analyzed together to form a composite stage (composite score) to predict maturity in patient at their peripubertal period. Ultimately the application of TOCI should not be limited to IS patients only. After the establishment of TOCI classification system, the staging system would be applied to radiographs from patients without spinal deformity or suffering from diseases not related to spine.

NCT ID: NCT03862417 Recruiting - Clinical trials for Degenerative Scoliosis

The Adult Degenerative Scoliosis Exercise Trial (Pilot Study)

ADSET
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Adult degenerative scoliosis is the most common spine deformity in adults. Patients present a lateral curvature of the spine and vertebra rotation. Curves meeting indications for treatment affect 24% of the aging adult population. Adult scoliosis causes pain, curve progression, and cosmetic deformity affecting quality of life and function. Pain affects 90% of patients with AS. Other than surgery for severe cases and pain medication, very little non-operative treatments have been investigated. Scoliosis-specific exercises have shown promise in a single study in adults and in an Alberta adolescent study. The goal of this pilot randomized controlled trial on the effect of Schroth exercises in adults with degenerative scoliosis compared to observation is to determine the feasibility of conducting a larger study. This study will help plan and secure funding for a larger study by examining the ability to recruit enough eligible participants, whether patients can follow the prescribed program session attendance and complete the home exercises prescribed. The early estimate the effects of the exercises on pain, quality of life, disability, deformity and posture measurements will help determine the potential of this approach and the likely success of a larger RCT. This study addresses a need of adults with degenerative scoliosis who do not meet surgical indications but still experience pain and disability by exploring a promising exercise approach.

NCT ID: NCT03825159 Recruiting - Clinical trials for Scoliosis; Adolescence

A New Spinal Orthosis for Adolescent Idiopathic Scoliosis

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The new device with digital technology provides a new avenue to enable clinicians to communicate wirelessly with the imbedded core system such that they can adjust the electrical stimulation parameters and retrieve the temperature data for further compliance analysis. The smart phone and cloud technology can be effectively applied for both security and convenience. The electrical stimulation technology integrated with the total contact spinal orthosis combines the external correction forces on the spinal skeleton from the passive orthosis with the muscle forces at the lateral trunk from the stimulation process. The electrical stimulation is purposely to tone the muscle in order to replace the external mechanical forces gradually. Ultimately, when being weaned off the orthosis, patients may maintain the correction.

NCT ID: NCT03716843 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

Start date: January 2, 2022
Phase:
Study type: Observational

Adolescent idiopathic scoliosis (AIS) involves three-dimensional spinal deformity in children aged between 10 and 16. Traditional braces modify the natural dynamics and thus the mechanical behaviour of the scoliotic spine through external constraints. Patients usually develop pressure ulcers and skin irritation when prescribed brace treatment for 18-23 hours per day. The excessive pressure, unknown pressure distribution and pressure shifting between the human body and the brace causes the effects of brace treatment to be unpredictable. Dynamic pressure monitoring system will be developed based on the body landmarks of scoliotic patients and critical areas where active pressure is applied by the brace. The overall pressure distribution and dynamic pressure between the body and the thoraco-lumbo-sacral orthosis (TLSO) rigid brace will be measured. The efficacy of the brace design will be evaluated, and the maximum compressive stresses that patients can endure on different body parts without pressure injury can be computed.

NCT ID: NCT03644407 Recruiting - Scoliosis Clinical Trials

Galeazzi Spine Surgery RegistryGaleazzi Spine Registry: Prospective Study for Clinical Monitoring

SPINEREG
Start date: November 10, 2015
Phase:
Study type: Observational [Patient Registry]

The SPINEREG study is a prospective observational registry. Eligible patients are subjects undergoing spine surgery at the participating institutions. Baseline health status and follow-up health status are recorded at pre-established steps.

NCT ID: NCT03641469 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Green Sun Medical Dynamic Scoliosis Brace

GSM
Start date: May 24, 2018
Phase: N/A
Study type: Interventional

This is a pilot study to collect preliminary short-term data concerning the safety and performance of the Green Sun Dynamic brace in a sample of subjects with adolescent idiopathic scoliosis who are currently being treated with a TLSO.

NCT ID: NCT03611244 Recruiting - Clinical trials for Duchenne Muscular Dystrophy

Prevention of Scoliosis in Patients With Duchenne Muscular Dystrophy Using Portable Seat Device

Start date: August 7, 2018
Phase: N/A
Study type: Interventional

This study will be conducted without blind method. The portable seat device devised to maintain lumbar lordosis will be made within 1 year after the loss of ambulation in the participants with Duchenne muscular dystrophy with prospective design. In the control group, the presence of scoliosis will be calculated 5 years after the loss of ambulation in participants with Duchenne muscular dystrophy through analysis of retrospective medical records who had not been applied the portable seat device.

NCT ID: NCT03582917 Recruiting - Clinical trials for Scoliosis; Adolescence

The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

ScoliVit
Start date: September 20, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this current prospective study is to determine the role of vitamin D in the development and restoration of spinal deformities in adolescence.