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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05942690
Other study ID # RC31/23/0146
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 30, 2023
Est. completion date July 31, 2023

Study information

Verified date January 2024
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 using ultrasound after abdominal osteopathic intervention (OMT).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date July 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
manual osteopathic intervention
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

Locations

Country Name City State
France Maison du Handball Créteil

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variation in the fraction of diaphragm thickening (right and left) measured on ultrasound before and after the procedure 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. Day 1
Secondary expiratory diaphragmatic thickness expiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention Day 1
Secondary Variation of the Forced Vital Capacity (FVC) measured in spirometry before and after the intervention The subject performs spirometry while standing with a Spirobank spirometer. 3 successive measurements keeping only the highest value. Day 1
Secondary Postural analysis 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 Day 2
Secondary Inspiratory diaphragmatic thickness Inspiratory diaphragmatic thickness will be measured by echography (mm) after manual abdominal osteopathic intervention day 1
Secondary diaphragmatic contraction velocity Diaphragmatic contraction velocity is expressed in % will be measured by echography after manual abdominal osteopathic intervention day 1
Secondary diaphragmatic amplitude Diaphragmatic amplitude is expressed in mm and will be measured by echography after manual abdominal osteopathic intervention day 1
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