- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05942690
Osteopathic Intervention in Professional Handball Players (ECHODIAPOST)
Ultrasound Evaluation of Diaphragmatic Contractility After Manual Osteopathic Intervention in Professional Handball Players: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The context is that of optimizing the performance of professional handball players. The aim is to study the effectiveness of a common osteopathic intervention in professional handball players on diaphragmatic contractility and its correlations with posture. This study has never been done in healthy subjects. It is a scientific process of objectification of an osteopathic technique commonly performed in this population.
The main objective is to assess diaphragmatic contractibility after abdominal osteopathic intervention (OMT).
The secondary objective is to evaluate the impact of this manual intervention in professional handball players on:
- other diaphragmatic ultrasound data
- on spirometry
- postural control
Prospective pilot non-interventional controlled monocentric study opened in healthy male and female International players who are part of the French Handball team. Approach to objectification of current practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Créteil, France, 94046
- Maison du Handball
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy male and female International players who are part of the French Handball team
Exclusion Criteria:
- history of thoracic or diaphragmatic surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental
The intervention evaluated is a technique of prolonged abdominal manual pressure centered on the zone of restriction of mobility called "trigger point" with diaphragmatic aim.
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The subject sits on the examination table for the manual osteopathic intervention.
The expert osteopath, having no report from the sonographers, will manually test breathing diaphragmatic and will bring osteopathic manual treatment to the area of mobility restriction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation in the fraction of diaphragm thickening (right and left) measured on ultrasound before and after the procedure
Time Frame: Day 1
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The subject undergoes the ultrasound which will investigate the contractility of the diaphragm muscle.
Two expert sonographers from G-ECHO will perform the ultrasound on each of the athletes, and note 3 successive measurements to check the stability of the results.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
expiratory diaphragmatic thickness
Time Frame: Day 1
|
expiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention
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Day 1
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Variation of the Forced Vital Capacity (FVC) measured in spirometry before and after the intervention
Time Frame: Day 1
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The subject performs spirometry while standing with a Spirobank spirometer.
3 successive measurements keeping only the highest value.
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Day 1
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Postural analysis
Time Frame: Day 2
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postural analysis will be perform using Cyber-Sabot type platform.
the measurements will be done at day 1 before manual abdominal osteopathic intervention and at day 2
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Day 2
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Inspiratory diaphragmatic thickness
Time Frame: day 1
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Inspiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention
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day 1
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diaphragmatic contraction velocity
Time Frame: day 1
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Diaphragmatic contraction velocity is expressed in % will be measured by echography after manual abdominal osteopathic intervention
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day 1
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diaphragmatic amplitude
Time Frame: day 1
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Diaphragmatic amplitude is expressed in mm and will be measured by echography after manual abdominal osteopathic intervention
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day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elise NOEL-SAVINA, MD, CHU Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/23/0146
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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