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CompletedNCT05252663Updated Dec 1, 2022

Effect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy

An interventional study of Quake device training and Traditional chest physiotherapy in Cerebral Palsy, sponsored by Cairo University. Completed at 2 sites in Egypt. Open to participants aged 6 Years to 8 Years. Per ClinicalTrials.gov, last updated 2022-12-01.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
6 Years to 8 Years
Sex
All
01

Study summary

Aim: To investigate the effect of intrathoracic oscillations on forced expiratory volume at first second and peak expiratory flow in the children with cerebral palsy.

Methods and Procedures: Children were randomly assigned into two groups (study group and control group). Each child was evaluated before and after 6 successive weeks.

Read the detailed description

Methods and Procedures: 24 children with spastic cerebral palsy from both sexes, There ages from 6 to 8 years old. Children were randomly assigned into two groups (study group and control group). Each child was evaluated before and after 6 successive weeks. The children of the control group received traditional chest physiotherapy. while, the children of the study group received 4 sessions per week for 6 weeks with quake device.

02

Conditions studied

  • Cerebral Palsy

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03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 24 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • children with cerebral palsy
  • Age from 6 to 8 years old
  • the degree of spasticity from 2 to 2+
  • grade 4, 5 according to GMFCs

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled convulsions
  • Any psychiatric disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Study group

    Quake breathing, patients were advised to take a deep breath and hold it for 3-5 seconds.

    Procedure: Quake device training

  • Active comparator
    Control group

    Percussion, vibration and shaking were used accompanied with postural drainage.

    Procedure: Traditional chest physiotherapy

Interventions

  • ProcedureQuake device training

    In Quake breathing, patients were advised to take a deep breath and hold it for 3-5 seconds. The patient had the mouthpiece firmly sealed to the lips and were asked to inhale and exhale completely

  • ProcedureTraditional chest physiotherapy

    postural drainage - percussion

06

What researchers measure

Primary outcomes

  1. FEV1

    Forced expiratory volume at first second

    Time frame: After 6 weeks

  2. PEF

    Peak expiratory flow

    Time frame: After 6 weeks

07

Study locations

2 sites
  • Faculty of Physical Therapy, Cairo University
    Cairo, 11432, Egypt
  • Faculty of physical therapy, Cairo university
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05252663
Lead sponsor
Cairo University
Responsible party
Mai Elsayed Abbass (Dr.Mai Elsayed Abbass, Lecturer of pediatric physical therapy, Cairo University) — Principal investigator
First posted
Feb 23, 2022
Start date
Jun 26, 2022
Primary completion
Aug 24, 2022
Completion
Aug 24, 2022
Last update
Dec 1, 2022

Study contacts

Mai Abbass, Ph.D.
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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