NCT05252663

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 13, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 26, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2022

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

February 13, 2022

Last Update Submit

November 30, 2022

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • FEV1

    Forced expiratory volume at first second

    After 6 weeks

  • PEF

    Peak expiratory flow

    After 6 weeks

Study Arms (2)

Study group

EXPERIMENTAL

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

Procedure: Quake device training

Control group

ACTIVE COMPARATOR

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

Procedure: Traditional chest physiotherapy

Interventions

Quake device trainingPROCEDURE

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

Study group
Traditional chest physiotherapyPROCEDURE

postural drainage - percussion

Control group

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Uncontrolled convulsions
  • Any psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Physical Therapy, Cairo University

Cairo, 11432, Egypt

Location

Faculty of physical therapy, Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mai Abbass, Ph.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Mai Elsayed Abbass, Lecturer of pediatric physical therapy

Study Record Dates

First Submitted

February 13, 2022

First Posted

February 23, 2022

Study Start

June 26, 2022

Primary Completion

August 24, 2022

Study Completion

August 24, 2022

Last Updated

December 1, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)