Cerebral PalsyNCT05252663
Effect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy
A study testing Quake device training and Traditional chest physiotherapy in people with Cerebral Palsy, run by Cairo University at 2 sites in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Quake device training and Traditional chest physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesEgypt
- Study dates
- 26 Jun 2022to 24 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Uncontrolled convulsions
- Any psychiatric disorders
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Physical Therapy, Cairo University
Cairo, 11432
Faculty of physical therapy, Cairo university
Cairo
About this study
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.
- Conditions
- Cerebral Palsy
- Being tested
- Quake device training, Traditional chest physiotherapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quake device trainingProcedure or surgery
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
Traditional chest physiotherapyProcedure or surgery
postural drainage - percussion
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Quake breathing, patients were advised to take a deep breath and hold it for 3-5 seconds. Receives: Procedure: Quake device training |
| Control group | Active comparator | Percussion, vibration and shaking were used accompanied with postural drainage. Receives: Procedure: Traditional chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Forced expiratory volume at first second
Measured: After 6 weeks
PEF
Peak expiratory flow
Measured: After 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start26 Jun 2022
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elsayed Abbass, Cairo University
- Investigators
- Mai Abbass, Ph.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252663
- Sponsor's protocol ID
- REC/012/003589
- Status last verified
- Nov 2022
- First submitted
- 13 Feb 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05252663
- Acronym / sponsor ID
- REC/012/003589
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Quake device trainingQuake breathing, patients were advised to take a deep breath and hold it for 3-5 seconds. |
| Control group | Active comparator | Procedure: Traditional chest physiotherapyPercussion, vibration and shaking were used accompanied with postural drainage. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Uncontrolled convulsions
- Any psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quake device trainingIn 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 | Procedure or surgery | Study group |
| Traditional chest physiotherapypostural drainage - percussion | Procedure or surgery | Control group |
Primary outcome
FEV1
Time frame: After 6 weeks
Forced expiratory volume at first second
PEF
Time frame: After 6 weeks
Peak expiratory flow
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai Abbass, Ph.D. principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quake device training and Traditional chest physiotherapy in people with Cerebral Palsy, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (time frame: After 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.