Development of an Interactive Digital Respiratory Game and Device and Investigation of Its Effectiveness in Children With Bronchiectasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interactive Digital Respiratory Game, home-based exercise training.
- Who it may be relevant to
- Registry conditions: Bronchiectasis. Basic parameters: 7 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Our study aims to develop a personalized interactive digital breathing game and device that can be produced in our country and to provide daily airway cleaning treatment at home via mobile phone or computer without the need for a physiotherapist or healthcare professional with the use of an interactive digital breathing game.
Detailed description
The disruption of airway clearance may lead to obstruction, respiratory infections, gas exchange deterioration, and an increase in mortality and morbidity. Airway clearance is especially crucial in children with bronchiectasis. Postural drainage, manual techniques, positive expiratory pressure, and chest oscillation devices are among airway clearance techniques. The repetitive and frequent use of these techniques strengthens adherence to therapy. With the development of technology and digitalization, Digital Respiratory Games (DRG) offer an alternative solution. DRGs, with their difficulty levels, provide a platform for progression, offering a fun and engaging experience that enhances patient adherence to therapy through storytelling and user interaction. The absence of a locally made DRG in Turkey, despite the chronic respiratory diseases impact, has led to the need for an interactive DRG with personalized features. The developed interactive DRG and device will be Turkey first interactive DRG example, designed to respond to different respiratory maneuvers. The developed DRG and device will detect the lung volume and flow rates and allow for the real-time execution of maneuvers within the Active Cycle of Breathing Techniques (ACBT) in a playful environment. The interactive DRG will enable airway clearance at home and in daily life, without the need for a physiotherapist, in a progressive, fun, and environmentally compatible manner, adjusted to capacity of the user. The interactive DRG and device possess useful model or patentable value and unique features. The aim of the study is to investigate the effectiveness of the locally produced interactive DRG and device in children with bronchiectasis.
The accepted and supported 2022-B-03 call for TUSEB project includes producing personalized interactive digital respiratory games and examining their effects in children with bronchiectasis. A total of 40 children (n=20 in the DRG group and n=20 in the control group) will participate in the study. Participants will perform physical activity exercises specific to their group's treatment protocol, twice a day for 7 days a week, over 8 weeks. Following treatment, their lung function, peripheral respiratory muscles, capacity, treatment adherence, quality of life, and treatment satisfaction will be assessed.
Interventions
- Device Interactive Digital Respiratory Game
With the development of technology and digitalization, Digital Respiratory Games (DRG) offer an alternative solution. DRGs, with their difficulty levels, provide a platform for progression, offering a fun and engaging experience that enhances patient adherence to therapy through storytelling and user interaction. The absence of a locally made DRG in Turkey, despite the chronic respiratory diseases impact, has led to the need for an interactive DRG with personalized features. The developed intera - Other home-based exercise training
Patients in the home-based exercise training group will be asked to perform the active breathing techniques cycle, which is an airway clearance technique, twice a day, 7 days a week, for 20 minutes each, for 8 weeks and to follow the program that includes physical activity recommendations. Patients who use mucolytic and/or nebulized drugs such as hypertonic saline or mannitol will be instructed to perform nebulization before performing the active breathing techniques cycle.
Primary outcome measures
- 6 Minute Walk Test [Time frame: baseline and within 1 week after intervention]
- Evaluation of Expiratory Muscle Strength [Time frame: baseline and within 1 week after intervention]
- Evaluation of Inspiratory Muscle Strength [Time frame: baseline and within 1 week after intervention]
Secondary outcome measures (8)
- Evaluation of Quality of Life [Time frame: baseline and within 1 week after intervention]
- Evaluation of Cough [Time frame: baseline and within 1 week after intervention]
- Assessment of Sleep Quality [Time frame: baseline and within 1 week after intervention]
- Evaluation of Peripheral Muscle Strength [Time frame: baseline and within 1 week after intervention]
- Respiratory Function Test- FEV1 value [Time frame: baseline and within 1 week after intervention]
- Respiratory Function Test- FVC value [Time frame: baseline and within 1 week after intervention]
- Respiratory Function Test- FEV1/FVC [Time frame: baseline and within 1 week after intervention]
- Respiratory Function Test- PEF value [Time frame: baseline and within 1 week after intervention]
Eligibility criteria
Inclusion criteria
- Aged between 7-18 years
- Clinically stable
- No exacerbations or infections
- Possesses a computer, tablet, or mobile phone
Exclusion criteria
- Participation in a supervised physiotherapy and rehabilitation program within the last 6 months
- History of lung or liver transplant
- Presence of any cognitive impairment that would hinder the use of the system
- Changes in medical treatment during the study
- Presence of concurrent cardiac, orthopedic, or neurological diseases
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Istanbul Atlas University — Istanbul
Identifiers
NCT: NCT06897761 · Hilal Denizoglu Kulli