Effect of Manual Diaphragmatic Activation on Diaphragm Fu... | NCT06268548

Studies
Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease

NCT06268548

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 20, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Diaphragm Dysfunction

Interventions

Manual diaphragmatic activation

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2023Actual

Primary Completion Date

Feb 20, 2024Estimated

Completion Date

Feb 27, 2024Estimated

First Submitted Date

Feb 4, 2024

First Submission Date that Met QC Criteria

Feb 12, 2024

First Posted Date

Feb 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2024

Last Update Posted Date

Feb 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shimaa Goda Sherif Ali, Demonstrator of physical therapy department for cardiothoracic/respiratory disorder & geriatric, faculty of physical therapy, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study	Experimental	Experimental , diaphragmatic activation with medical treatment ,15patients with gastroesophageal reflux disease do manual diaphragmatic activation in additional to traditional medical treatment	Other: Manual diaphragmatic activation
Control	No Intervention	30 patients with gastroesophageal reflux disease taking traditional medical treatment only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Manual diaphragmatic activation	Other	Manual diaphragm release on diaphragm	Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diaphragm Excursion	Diaphragm Excursion	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
open wound
abdominal or spinal surgery
Congenital or acquired disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Both gender patients

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shimaa Goda Sherif, Master	Contact	01008804063		shimaaagoda@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of physical therapy	Recruiting	Giza		12613	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided