Pectus ExcavatumNCT06635083
Investigation of the Effectiveness of Telerehabilitation Training in Pectus Excavatum Deformity
A study testing Telerehabilitation in people with Pectus Excavatum, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 years, men only
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- Telerehabilitation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children aged 10-14
- Boys
- Those who have undergone Vacuum Bell treatment for the first time
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara Üniversitesi Pendik Eğitim Ve Araştirma Hastanesi
Istanbul, Istanbul, 34000
BÜŞRA AKGÖNÜL, 05334902102, busrakgonul@gmail.com
About this study
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
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.
Read the 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
- Being tested
- Telerehabilitation
- Keywords
- Telerehabilitation, Posture, Congenital Abnormalities, Quality of Life, Physical Fitness, Respiratory Function Tests
- Medical subject headings
- Funnel Chest, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vacuum bell therapy | Active comparator | This group will use a vacuum bell for one hour in the morning and evening, as recommended by an experienced thoracic surgeon. Receives: Other: Telerehabilitation |
| Vacuum bell therapy+telerehabilitation | Experimental | 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. Receives: Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Fitness
Health-Related Physical Fitness
Health-related physical fitness will be assessed using the FITNESSGRAM® test battery. This test battery was developed to record the abilities of his children.
Health-related physical fitness components:
- Aerobic capacity
- Body composition
- Strength
- Endurance
- Flexibility
Measured: 6 months
Secondary outcomes (1)
Pulmonary functions
Pulmonary functions will be assessed by two devices.
- Forced Expiratory Volume in 1 Second (FEV1) Forced Vital Capacity (FVC) Voluntary Ventilation (MVV) will be measured by a portable spirometer device.
- Peak Expiratory Flow (PEF) will be measured by Peak Flow Meter
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental single-blind randomized comparative study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emine H Tüzün, Study director, Eastern Mediterrenian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635083
- Sponsor's protocol ID
- EMU-FTR-BA-01
- Status last verified
- Oct 2024
- First submitted
- 26 Aug 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06635083
- Acronym / sponsor ID
- EMU-FTR-BA-01
- Conditions
- Pectus Excavatum
- Keywords
- Telerehabilitation, Posture, Congenital Abnormalities, Quality of Life, Physical Fitness, Respiratory Function Tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Quasi-experimental single-blind randomized comparative study
| Arm | Type | Receives |
|---|---|---|
| Vacuum bell therapy | Active comparator | Other: TelerehabilitationThis group will use a vacuum bell for one hour in the morning and evening, as recommended by an experienced thoracic surgeon. |
| Vacuum bell therapy+telerehabilitation | Experimental | Other: TelerehabilitationTelerehabilitation 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 10-14
- Boys
- Those who have undergone Vacuum Bell treatment for the first time
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationA 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. | Other | Vacuum bell therapy, Vacuum bell therapy+telerehabilitation |
Primary outcome
Physical Fitness
Time frame: 6 months
Health-Related Physical Fitness Health-related physical fitness will be assessed using the FITNESSGRAM® test battery. This test battery was developed to record the abilities of his children. Health-related physical fitness components: * Aerobic capacity * Body composition * Strength * Endurance * Flexibility
1 secondary outcome
Pulmonary functions
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine H Tüzün study director
Eastern Mediterrenian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Pectus Excavatum, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BÜŞRA AKGÖNÜL, Master (+905334902102, busrakgonul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Fitness (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.