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临床试验/NCT06897761
NCT06897761招募中不适用

Development of an Interactive Digital Respiratory Game and Device and Investigation of Its Effectiveness in Children With Bronchiectasis

Atlas University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
6 Minute Walk Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Aged between 7-18 years
  • •Clinically stable
  • •No exacerbations or infections
  • •Possesses a computer, tablet, or mobile phone

排除标准

  • •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

研究组 & 干预措施

Breathing Game Group

Experimental

The participants will perform the interactive digital game.

干预措施: Interactive Digital Respiratory Game (Device)

Breathing Game Group

Experimental

The participants will perform the interactive digital game.

干预措施: home-based exercise training (Other)

Control Group

Active Comparator

The participants will perform home based exercise

干预措施: home-based exercise training (Other)

结局指标

主要结局

6 Minute Walk Test

时间窗: baseline and within 1 week after intervention

6MWT is defined as a submaximal test that can be easily applied in healthy or unhealthy individuals and is evaluated as an indicator of exercise capacity and walking capacity as well as many cardiovascular diseases. The 6MWT is referred to as the "Gold Standard" test of walking capacity. The aim of this test is to reach the longest possible walking distance at the end of six minutes. The standard protocol is applied in a 30-meter uninterrupted corridor or open area. It is recommended to repeat the 6MWT three times on the same day with a one-hour rest interval; the maximum walking distance is taken into account.

Evaluation of Expiratory Muscle Strength

时间窗: baseline and within 1 week after intervention

Inspiratory and expiratory respiratory muscle strength will be evaluated by measuring maximal mouth pressure. Maximal mouth pressure will be measured using the Micro RPM brand (Micro Medical; England) portable electronic mouth pressure measurement device, in accordance with ATS/ERS criteria. Maximal expiratory pressure (MEP) will be measured to assess expiratory muscle strength.

Evaluation of Inspiratory Muscle Strength

时间窗: baseline and within 1 week after intervention

Inspiratory and expiratory respiratory muscle strength will be evaluated by measuring maximal mouth pressure. Maximal mouth pressure will be measured using the Micro RPM brand (Micro Medical; England) portable electronic mouth pressure measurement device, in accordance with ATS/ERS criteria. Maximal inspiratory pressure (MIP) will be measured to assess inspiratory muscle strength,.

次要结局

  • Respiratory Function Test- FEV1/FVC(baseline and within 1 week after intervention)
  • Evaluation of Quality of Life(baseline and within 1 week after intervention)
  • Evaluation of Cough(baseline and within 1 week after intervention)
  • Assessment of Sleep Quality(baseline and within 1 week after intervention)
  • Evaluation of Peripheral Muscle Strength(baseline and within 1 week after intervention)
  • Respiratory Function Test- FEV1 value(baseline and within 1 week after intervention)
  • Respiratory Function Test- FVC value(baseline and within 1 week after intervention)
  • Respiratory Function Test- PEF value(baseline and within 1 week after intervention)

研究者

发起方
Atlas University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hilal Denizoğlu Külli

Assoc. Prof.

Atlas University

研究点 (1)

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