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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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)
Show all 9Show fewer
  • 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.

BÜŞRA AKGÖNÜL, Master contact

+905334902102

busrakgonul@gmail.com

Turkey (Türkiye)1 site
  • Marmara Üniversitesi Pendik Eğitim Ve Araştirma Hastanesi

    Istanbul, Istanbul, 34000

    BÜŞRA AKGÖNÜL, 05334902102, busrakgonul@gmail.com

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06635083
Study groupRoleWhat they receive
Vacuum bell therapyActive comparatorThis 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+telerehabilitationExperimentalTelerehabilitation 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.

  1. 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)
  1. Pulmonary functions

    Pulmonary functions will be assessed by two devices.

    1. Forced Expiratory Volume in 1 Second (FEV1) Forced Vital Capacity (FVC) Voluntary Ventilation (MVV) will be measured by a portable spirometer device.
    2. 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.

  1. First posted10 Oct 2024
  2. Study start10 Oct 2024 (estimated)
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

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)
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

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.

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