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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05236816
Other study ID # 2021/655
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 7, 2022
Est. completion date April 2022

Study information

Verified date February 2022
Source Centre Hospitalier Universitaire de Besancon
Contact Fabrice MICHEL, MD PhD
Phone +33 3 81 66 82 48
Email fmichel@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ankle sprains are one of the most common injuries in sports. The analysis of risk factors is a priority in order to guide rehabilitation and prevention programs. Among risk factors identified in the literature, weakness of the hip abductor muscles represent a factor favoring recurrent ankle sprains. However, only few studies have investigate the link between the strength of the hip abductor muscles and the deficits in stabilization of the ankle joint. Furthermore, these few studies analysed landing task or undisturbed balance task. It would be interesting to further understand the impact and role of hip abductor muscles on ankle stability during specific ankle-destabilizing task. The main objective of this study is to establish a link between the strength of the hip abductor muscles and the dynamic postural control performance measured by the modified Star Excursion Balance Test (SEBTm). Secondly, it will be necessary to study the kinematic and neuromuscular control characteristics of the ankle during 4 functional tests: - SEBTm - Static unipodal balance - Weight-bearing inversion test - Weight-bearing eversion test These tests will be realized with an ankle destabilizing device. The device is a sandal equipped of an articulator under the rear foot which allow movements in inversion and eversion. Furthermore, tests are realized two times, before and immediatly after a fatiguing exercise. The fatiguing exercise consists to implemented local fatigue on hip abductor muscles by repeating abductions.


Recruitment information / eligibility

Status Recruiting
Enrollment 26
Est. completion date April 2022
Est. primary completion date March 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Males and females between 18 and 35 years old - Subject's non-opposition to participate in the study - Practicing regular physical activity (> 2 hours per week) - No contraindication to carrying out the protocol - Affiliation to a French social security scheme or beneficiary of such a scheme Exclusion Criteria: - Males or females under 18 or over 35 years - History of lower limb injuries in the 6 months preceding the protocol - Diagnosis of chronic ankle instability - Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator - Subject's opposition to participating in the study - Subject without health insurance - Pregnant woman

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fatigue (physical exercise)
Subjects were evaluated before and after a fatiguing exercise of hip abductor muscles that consisted to repeat hip abduction with rate and range of motion until a target decrease of force is attempt

Locations

Country Name City State
France CHU de Besançon Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surface Electromyography intensity change Measure of muscles activity if peroneus longus and brevis, tibialis anterior, gluteus medius and gastrocnemuis lateralis using wireless and surface electrodes fixed with strap on the skin of subjects 5 minutes before physical exercise
Primary Surface Electromyography intensity change Measure of muscles activity if peroneus longus and brevis, tibialis anterior, gluteus medius and gastrocnemuis lateralis using wireless and surface electrodes fixed with strap on the skin of subjects 5 minutes after physical exercise
Primary Frontal inclination of ankle change Measure of accelerations of ankle joint during tests using inertial measurement unit 5 minutes before physical exercise
Primary Frontal inclination of ankle change Measure of accelerations of ankle joint during tests using inertial measurement unit 5 minutes after physical exercise
Primary SEBT performances change Performances (distance in cm) attempted in each direction of the dynamic postural test 5 minutes before physical exercise
Primary SEBT performances change Performances (distance in cm) attempted in each direction of the dynamic postural test 5 minutes after physical exercise
Primary Hip abductor strength change Measure of maximal isometric strength with a S-shape force transducer 5 minutes before physical exercise
Primary Hip abductor strength change Measure of maximal isometric strength with a S-shape force transducer 5 minutes after physical exercise
Primary Angular velocity of ankle change Measure of angular velocity of ankle joint during tests using inertial measurement unit 5 minutes before physical exercise
Primary Angular velocity of ankle change Measure of angular velocity of ankle joint during tests using inertial measurement unit 5 minutes after physical exercise
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