NCT07722364

Brief Summary

the study will concentrate on the effect of High Frequency Chest Wall Oscillation compared to conventional pulmonary physiotherapy on children with non cystic fibrosis bronchiectasis

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jul 2026Jan 2027

First Submitted

Initial submission to the registry

June 2, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

June 2, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

HFCWO, cystic fibrosis, bronchiectasis

Outcome Measures

Primary Outcomes (3)

  • Forced Expiratory Volume in 1 second (FEV1)

    Change in FEV1 measured by spirometry according to ATS/ERS guidelines

    Baseline and after 8 weeks of treatment

  • Forced Vital Capacity (FVC)

    Change in FVC measured by spirometry according to ATS/ERS guidelines

    Baseline and after 6 months of treatment

  • FEV1/FVC Ratio

    Change in FEV1/FVC ratio measured by spirometry according to ATS/ERS guidelines

    Baseline and after 6 months of treatment

Secondary Outcomes (1)

  • Six-Minute Walk Distance (6MWD)

    Baseline and after 6 months of treatment

Study Arms (2)

children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional progr

EXPERIMENTAL

This group will include 30 children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional program of physiotherapy given to the control group. The frequency of treatment will be 5 sessions/week for three successive months for both groups for long term effect and daily for immediate effect.

Device: High Frequency Chest Wall Oscillation

children who will be treated by conventional physiotherapy program

ACTIVE COMPARATOR

Patients in this group will be 30 children who will be treated by conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.

Other: conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.

Interventions

High-frequency chest wall oscillation that applies external chest wall oscillations via an inflatable vest worn around the thoracic cage, increasing the air-liquid shear forces during expiration is believed to result in secretion mobilization. The product name that will be used is Air Way Clearness system; his model is PV-900/ PV-300/PV-100, made in China.

children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional progr

conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life. Conventional physiotherapy that will be applied to the control group for 30 minutes will include: * Postural drainage according to accumulation of secretions for 10 minutes accompanied by percussion or vibration * Active cycle breathing technique (ACBT) for 10 minutes * Respiratory exercises for 10 minutes

children who will be treated by conventional physiotherapy program

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with no cystic fibrosis bronchiectasis
  • Both sexes
  • Their ages ranges from 6-12 years
  • After 48 hours of attack, if hemoptysis or fever not found

You may not qualify if:

  • Osteoporosis (Calcium deficiency)
  • Bleeding tendency
  • Recent surgery of brain, eye, thoracic, or neck surgery
  • Pneumothorax
  • Cystic fibrosis bronchiectasis
  • Pulmonary embolism
  • Rib fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

pediatric hospital, Assiut university

Asyut, Egypt

Location

MeSH Terms

Conditions

Cystic FibrosisBronchiectasis

Interventions

Chest Wall OscillationQuality of Life

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBronchial Diseases

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeuticsHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, Faculty of Physical Therapy Sphinx University

Study Record Dates

First Submitted

June 2, 2026

First Posted

July 23, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations