- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05817565
Physical Therapy on Phrenic Nerve Function
April 17, 2023 updated by: Khaled Takey Ahmed, Cairo University
Outcomes of Physical Therapy Program on Respiratory and Phrenic Nerve Functions in Cervical Disc Compression
This study was conducted to investigate the effects of a designed physical therapy program on respiratory function and phrenic nerve activity in cervical disc compression.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Twenty patients from the Spinal Unite represented the sample of the study.
Their mean ages were 43 years and they suffering from acute cervical disc compression at the level of cervical 3, 4, 5. Methods: Evaluation was carried out before and after three months of treatment.
It included measuring of pulmonary functions (VC, FVC, FEV1, PEF and MVV) by using spirometer, diaphragmatic excursion and thoracic volume via x-ray and conduction velocity and amplitude of phrenic nerve using electromyography.
Treatment program included heat application, ultrasound, cervical traction and diaphragmatic breathing exercises.
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: KHALED T AHMED, Asso Prof
- Phone Number: 01115586016
- Email: khaled.takey@must.edu.eg
Study Contact Backup
- Name: abla h saleh, prof
- Phone Number: 01001521055
- Email: Abla_hamed2000@yahoo.com
Study Locations
-
-
Ben El Sarayat
-
Giza, Ben El Sarayat, Egypt
- Recruiting
- Cairo University
-
Contact:
- NISREEN A EL AHASS, PROF
- Phone Number: 0237969108
- Email: nissreen.elnahas@cu.edu.eg
-
Contact:
- assma f attalah
- Phone Number: 00201117744974
- Email: Zayedsameh40@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
study was conducted on 20 patients with compression of the cervical disc at the level of 3, 4, and 5. Their mean age was 43 years; mean weight was 75 kg and mean height was 170cm.They suffered from cervical disc compression for 6-8 months.
Description
Inclusion Criteria:
- suffered from cervical disc compression for 6-8 months.
- patients examined and referred by physician.
Exclusion Criteria:
- Any cardio pulmonary disorders which may alter pulmonary function.
- They did not receive any physical therapy program prior to their participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
intervention group
Patients underwent physical therapy program 3days/week for three months in the form of
|
Intermittent cervical traction (traction force equal 8% of body weight) was applied with the patient lying supine and the head in neutral position.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pulmonary function test
Time Frame: 4 months
|
to measure vital capacity
|
4 months
|
phrenic nerve amplitude
Time Frame: 4 months
|
objective method to detect phrenic nerve function
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Maha m El monem, Ass Prof, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Carvalho, M. De (2004) Electrodiagnostic assessment of respiratory dysfunction in motor neuron disease, Handbook of Clinical Neurophysiology. Elsevier B.V. doi: 10.1016/S1567-4231(04)04029-8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Anticipated)
May 15, 2023
Study Completion (Anticipated)
May 30, 2023
Study Registration Dates
First Submitted
April 5, 2023
First Submitted That Met QC Criteria
April 17, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 17, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- respiration and phrenic
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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