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ACTIVE NOT RECRUITING
NCT07765264
NA

Clinical and Autonomic Efficacy of Digital-Gamified Diaphragmatic Training in Pediatric Pulmonary Rehabilitation

Sponsor: Delta University for Science and Technology

View on ClinicalTrials.gov

Summary

Adherence to traditional pediatric pulmonary rehabilitation exercises is often low due to their repetitive nature, leading to poor respiratory outcomes. Digital-Gamified Diaphragmatic Training (DGDT) integrates real-time biofeedback into smartphone applications to turn breathing exercises into interactive games, encouraging children to practice more consistently. The purpose of this prospective, randomized controlled clinical trial is to evaluate the clinical efficacy of a 12-week home-based DGDT protocol compared to standard mechanical incentive spirometry among pediatric patients aged 6 to 14 years with chronic respiratory conditions. The primary goal is to assess changes in key spirometric parameters-specifically Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC), and the FEV1/FVC ratio-to determine if gamified digital training offers physiological benefits over standard rehabilitation methods.

Key Details

Gender

All

Age Range

6 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2026-04-01

Completion Date

2026-09

Last Updated

2026-08-14

Healthy Volunteers

No

Interventions

BEHAVIORAL

Digital-Gamified Diaphragmatic Training (DGDT)

Interactive mobile application providing real-time biofeedback and acoustic/visual gamification mechanics to guide slow, deep diaphragmatic breathing and prolonged exhalations.

DEVICE

Standard Mechanical Incentive Spirometer

Standard non-gamified three-ball plastic incentive spirometer utilized for daily respiratory exercise with manual logbook recording.

Locations (1)

Outpatient Pediatric Pulmonology Clinics, Damietta

Damietta, Egypt