Clinical trial NCT06635083: Investigation of the Effectiveness of Telerehabilitation Training in Pectus Excavatum Deformity
Official title: Comparison of the Effects of Vacuum Bell Therapy and Additional Telerehabilitation on Physical Fitness, Respiratory Functions, Posture and Psychosocial Factors in Children with Pectus Excavatum : a Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pectus Excavatum
Keywords: Telerehabilitation
Posture
Congenital Abnormalities
Quality of Life
Physical Fitness
Respiratory Function Tests
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 62
Sex: MALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental single-blind randomized comparative study
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effectiveness of telerehabilitation-based exercise training in addition to Vacuum Bell therapy on physical fitness, respiratory functions, posture and psychosocial factors in boys aged between 10-14 years diagnosed with pectus excavatum.

Detailed description: Pectus excavatum (PE) is the most common congenital chest wall deformity. It is seen in approximately 1 in 400 live births. PE is characterized by varying degrees of depression of the sternum and rib cartilage. Although its etiopathogenesis is not fully understood, it is thought to be caused by intrauterine pressure on the sternum from an abnormal fetal position, sequelae of diseases such as syphilis and rickets, muscle imbalances in the anterior diaphragm that pull the xiphoid and sternum backwards, and abnormal growth of the costal cartilage junction between the rib and the sternum.

In a typical PE, the lower 1/3 of the sternum and adjacent costal cartilages are seen to collapse. Children with PE are usually tall and have abnormal posture. Scoliosis has been diagnosed in approximately 29% of children with PE. Studies have shown that the most common posture disorders in children with PE are; head forward posture, rounded shoulders, thoracic kyphosis, winged scapula and anterior rotation of the pelvis. In children with PE; decreased flexibility of the upper trapezius, scalene, sternocleidomastoid, pectoralis major muscles; loss of strength in the back extensors, abdominals, quadratus lumborum, lower/middle part of the trapezius and rhomboids have been reported. In addition to orthopedic problems; psychosocial problems related to physical appearance such as body image anxiety, social isolation, introversion, shyness, anxiety and depression have also been detected. It has been predicted that restriction of activities, poor posture and avoidance of sports activities due to deterioration of physical appearance may lead to weakness and other problems in the musculoskeletal system. In addition, it has been published that the cardiovascular endurance of adolescents with moderate and severe PE is lower than that of healthy controls, causing these patients to have reduced physical activity. In recent years, conservative treatment approaches have been increasing. The main conservative treatment methods applied for these patients are vacuum bell treatment, orthosis and physiotherapy. A rehabilitation program planned according to the needs of the person can help increase the quality of life of the individual with PE. Studies have reported that various exercise applications contribute to a decrease in deformity and positive developments in posture. Telerehabilitation is defined as a rehabilitation method carried out remotely between the patient and the health professional through telecommunication technologies such as telephone, internet, and video conference. Telerehabilitation methods can be quite effective in terms of high participation and compliance rates, behavioral changes in lifestyle, the opportunity for the patient to receive rehabilitation in their own environment, the chance to benefit from rehabilitation for a longer period of time and cost efficiency. In addition, the rate at which the rehabilitation program is affected by the low number of specialists in the geography where the patient lives, the lack of transportation facilities and physical disabilities is minimized thanks to telerehabilitation. Accessibility, flexible hours that can adapt to children's busy school programs and time savings, the opportunity for the participation of their families and the interest of children in technology are thought to motivate them to participate in treatment. In the literature study, no study was found showing the effectiveness of exercise training applied with telerehabilitation in children with pectus excavatum deformity. The purpose of this study is to examine the effectiveness of telerehabilitation-based exercise training applied in addition to Vacuum Bell treatment on physical fitness, respiratory functions, posture and psychosocial factors in boys between the ages of 10-14 diagnosed with pectus excavatum.

Eligibility criteria: Inclusion Criteria:

* Children aged 10-14
* Boys
* Those who have undergone Vacuum Bell treatment for the first time

Exclusion Criteria:

* Those with complex type pectus deformity
* Those who have undergone any surgical treatment due to pectus excavatum
* Those with chronic systemic disease (cardiovascular, gastrointestinal, metabolic)
* Those with diagnosed serious psychiatric disease
* Those with scoliosis over 20 degrees
* Those with other musculoskeletal anomalies and connective tissue disorders (Marfan syndrome, Turner syndrome, neurofibromatosis tuberous sclerosis)
* Those with neurological disease
* Those with hearing or vision impairment that cannot be corrected with hearing aids or glasses
* Those who do not have internet access or do not own a tablet/computer

Primary outcomes:
measure: Physical Fitness
timeFrame: 6 months
Secondary outcomes:
measure: Pulmonary functions
timeFrame: 6 months
Other outcomes:
measure: Posture
timeFrame: 6 months
measure: Handgrip strength
timeFrame: 6 months
measure: Body Image Perception
timeFrame: 6 months
measure: Social Anxiety
timeFrame: 6 months
measure: Psychological State
timeFrame: 6 months
measure: Quality of life assessment
timeFrame: 6 months
Locations:
city: İstanbul
country: Turkey
facility: Marmara Üniversitesi Pendik Eğitim Ve Araştirma Hastanesi
Study officials:
affiliation: Eastern Mediterrenian University
name: Emine H Tüzün
role: STUDY_DIRECTOR
References: