Investigation of the Effectiveness of Telerehabilitation Training in Pectus Excavatum Deformity

NCT ID: NCT06635083

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2025-04-30

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.

Conditions

Pectus Excavatum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vacuum bell therapy

This group will use a vacuum bell for one hour in the morning and evening, as recommended by an experienced thoracic surgeon.

Group Type: ACTIVE_COMPARATOR

Telerehabilitation

Intervention Type: OTHER

A video conference software system will be installed on the subjects' laptops or tablets. Then, via video conference, strengthening/stretching exercises and breathing exercises will be performed for the areas affected by the deformity with the physiotherapist three times a week.

Vacuum bell therapy+telerehabilitation

Telerehabilitation based exercises and vacuum bell therapy will be applied to this group. Video conference software system will be installed on the subjects' laptops or tablets. After the evaluations, exercises will be taught to the individuals in the clinic. Then, the following exercises will be done with the physiotherapist via video conference 3 sessions per week.

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: OTHER

A video conference software system will be installed on the subjects' laptops or tablets. Then, via video conference, strengthening/stretching exercises and breathing exercises will be performed for the areas affected by the deformity with the physiotherapist three times a week.

Interventions

Telerehabilitation

A video conference software system will be installed on the subjects' laptops or tablets. Then, via video conference, strengthening/stretching exercises and breathing exercises will be performed for the areas affected by the deformity with the physiotherapist three times a week.

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Eastern Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emine H Tüzün

Role: STUDY_DIRECTOR

Eastern Mediterrenian University

Locations

Marmara Üniversitesi Pendik Eğitim Ve Araştirma Hastanesi

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

BÜŞRA AKGÖNÜL, Master

Role: CONTACT

busrakgonul@gmail.com

+905334902102

Facility Contacts

BÜŞRA AKGÖNÜL

Role: primary

busrakgonul@gmail.com

05334902102

Other Identifiers

EMU-FTR-BA-01

Identifier Type: -

Identifier Source: org_study_id