NCT06268548

Brief Summary

This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2024

Completed
Last Updated

February 20, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

February 4, 2024

Last Update Submit

February 12, 2024

Conditions

Diaphragm Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Diaphragm Excursion

    Diaphragm Excursion

    2 months

Study Arms (2)

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

Manual diaphragmatic activationOTHER

Manual diaphragm release on diaphragm

Study

Eligibility Criteria

Age20 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth gender patients
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • open wound
  • abdominal or spinal surgery
  • Congenital or acquired disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, 12613, Egypt

RECRUITING

Central Study Contacts

Shimaa Goda Sherif, Master

CONTACT

01008804063shimaaagoda@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of physical therapy department for cardiothoracic/respiratory disorder & geriatric, faculty of physical therapy

Study Record Dates

First Submitted

February 4, 2024

First Posted

February 20, 2024

Study Start

September 15, 2023

Primary Completion

February 20, 2024

Study Completion

February 27, 2024

Last Updated

February 20, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)