Diaphragm DysfunctionNCT06268548
Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease
A study testing Manual diaphragmatic activation in people with Diaphragm Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Dysfunction
- What is being tested?
- Manual diaphragmatic activation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2023to 27 Feb 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with gastroesophageal reflux disease.
- the age will be ranged from 20 to 50 .
- body mass index from 20 to 34,9 kg/m2 .
- low level of physical therapy
Who cannot join
- Pregnancy
- open wound
- abdominal or spinal surgery
- Congenital or acquired disorder
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy
Giza, 12613
Nesreen Ghareb Mohamed, Professor, 01002227242, nesreen.elnahas@pt.cu.edu.eg
About this study
This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease
Read the detailed description
Thirty both gender patients with gastroesophageal reflux disease enrolled in this study , study group And control group. To investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease
- Conditions
- Diaphragm Dysfunction
- Being tested
- Manual diaphragmatic activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual diaphragmatic activationOther
Manual diaphragm release on diaphragm
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Experimental , diaphragmatic activation with medical treatment ,15patients with gastroesophageal reflux disease do manual diaphragmatic activation in additional to traditional medical treatment Receives: Other: Manual diaphragmatic activation |
| Control | No intervention | 30 patients with gastroesophageal reflux disease taking traditional medical treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Excursion
Diaphragm Excursion
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Sep 2023
- Primary completion20 Feb 2024 (estimated)
- Study completion27 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm DysfunctionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Goda Sherif Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268548
- Sponsor's protocol ID
- P.T.REC/012/004790
- Status last verified
- Dec 2023
- First submitted
- 4 Feb 2024
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT06268548
- Acronym / sponsor ID
- P.T.REC/012/004790
- Conditions
- Diaphragm Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 27 Feb 2024 (estimated)
- First posted
- 20 Feb 2024 (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.
This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease
Detailed description
Thirty both gender patients with gastroesophageal reflux disease enrolled in this study , study group And control group. To investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Other: Manual diaphragmatic activationExperimental , diaphragmatic activation with medical treatment ,15patients with gastroesophageal reflux disease do manual diaphragmatic activation in additional to traditional medical treatment |
| Control | No intervention | –30 patients with gastroesophageal reflux disease taking traditional medical treatment only |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with gastroesophageal reflux disease.
- the age will be ranged from 20 to 50 .
- body mass index from 20 to 34,9 kg/m2 .
- low level of physical therapy
Key exclusion criteria (4 listed)
- Pregnancy
- open wound
- abdominal or spinal surgery
- Congenital or acquired disorder
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 |
|---|---|---|
| Manual diaphragmatic activationManual diaphragm release on diaphragm | Other | Study |
Primary outcome
Diaphragm Excursion
Time frame: 2 months
Diaphragm Excursion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual diaphragmatic activation in people with Diaphragm Dysfunction, run by Cairo University at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa Goda Sherif, Master (01008804063, shimaaagoda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Excursion (time frame: 2 months). 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 20 Feb 2024.