CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Dynamic compression brace +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03559244
NCT03559244N/ACompleted

Investigating the Effects of Exercises in Addition to Dynamic Compression Brace in Patients With Pectus Carinatum: a Single Blinded Randomized Controlled Trial

Marmara University·interventional·Posted Jun 18, 2018·Updated Dec 4, 2018

In Brief

A clinical study evaluating Dynamic compression brace and Exercises for Pectus Carinatum. Completed, enrolled 27 participants across 1 site.

Detailed Summary

Pectus carinatum (PC) is a deformity of the anterior chest wall which is a common pediatric condition, characterized by an idiopathic overgrowth of the costal cartilages resulting in protrusion of the sternum. Chest pain or discomfort, especially when lying in prone position, increased respiratory effort during exercise, scoliosis, impaired shoulders and kyphotic position are some of the physical signs and symptoms. Unlike pectus excavatum, PC is rarely associated with significant cardiopulmonary involvement except in severe cases. Pectus carinatum is not just a simple aesthetical problem. The effect of patient's self-esteem, body image and confidence can be variable and lead to significant deterioration in mental health. It can be responsible of physical signs and symptoms and also has significant psychological impact. Deformity and its psychological impact tend to worsen during pubertal rapid phases of growth and even during adult life. The management of pectus deformities used to include surgical techniques, however, recently compression brace which is a dynamic orthosis which is custom-fitted, rigid aluminum brace that is adjustable to any thoracic shape is widely applied instead of surgery. Pressure applied to the patient, in the most protruding area of the chest, needed to accomplish a proper shape of the thorax, the pressure of correction can be measured via a pressure measuring device in pounds per square inches (PSI). Treatment choices of surgery or bracing is determined according to pressure of correction and type of deformity. Surgical correction is indicated if the presence of chondro-manubrial type PC and pressure of correction \> 10 PSI. Chest pain or discomfort, especially when lying in prone position, increased respiratory effort during exercise, scoliosis, impaired shoulders and kyphotic position are some of the physical signs and symptoms. Despite the fact that patients with PC have impaired posture, exercise intolerance and increased scoliosis occurrence, there is no consensus on the exercise program for patients with PC. Also, there is not enough scientific evidence about the wear time of orthosis. The aim of this study is to investigate the effects of exercises and compression brace in children with PC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 18, 2018
Enrollment StartJul 1, 2018
Primary CompletionDec 2, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.0 years ago

Interventions

Dynamic compression braceother

custom-fitted brace adjusts the pressure on the thoracic wall and enables lateral expansion of the thorax

Exercisesother

posture exercises, deep breathing exercises, exercises for manipulation and mobilization of ribs, and core exercises