Investigation of the Effectiveness of Telerehabilitation Training in Pectus Excavatum Deformity

NCT06635083 | Not Yet Recruiting

• 1 other identifier: EMU-FTR-BA-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum

Keywords

Telerehabilitation; Posture; Congenital Abnormalities; Quality of Life; Physical Fitness; Respiratory Function Tests

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (1)

• Pulmonary functions

  6 months

Other Outcomes (6)

• Posture

  6 months

• Handgrip strength

  6 months

• Body Image Perception

  6 months

Study Arms (2)

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.

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.

Other: Telerehabilitation

Interventions

Telerehabilitation 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; Vacuum bell therapy+telerehabilitation

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Marmara Üniversitesi Pendik Eğitim Ve Araştirma Hastanesi

Istanbul, Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Funnel Chest; Congenital Abnormalities

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Emine H Tüzün

  Eastern Mediterrenian University

  STUDY DIRECTOR

Central Study Contacts

BÜŞRA AKGÖNÜL, Master

CONTACT

+905334902102; busrakgonul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants with pectus excavatum deformity between the ages of 10 and 14 who apply to the clinic where the study will be conducted by dividing into two groups using the random allocation software computer program.The outcomes assessor will not know which groups individuals assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-experimental single-blind randomized comparative study

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: October 10, 2024
• Study Start: October 10, 2024
• Primary Completion: January 31, 2025
• Study Completion: April 30, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)