NCT05236816

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 17, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2022

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 month

First QC Date

December 17, 2021

Last Update Submit

September 5, 2024

Conditions

Keywords

BalanceAnkleDestabilizationPreventionHip fatigue

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • Frontal inclination of ankle change

    Measure of accelerations of ankle joint during tests using inertial measurement unit

    5 minutes before physical exercise

  • Frontal inclination of ankle change

    Measure of accelerations of ankle joint during tests using inertial measurement unit

    5 minutes after physical exercise

  • SEBT performances change

    Performances (distance in cm) attempted in each direction of the dynamic postural test

    5 minutes before physical exercise

  • SEBT performances change

    Performances (distance in cm) attempted in each direction of the dynamic postural test

    5 minutes after physical exercise

  • Hip abductor strength change

    Measure of maximal isometric strength with a S-shape force transducer

    5 minutes before physical exercise

  • Hip abductor strength change

    Measure of maximal isometric strength with a S-shape force transducer

    5 minutes after physical exercise

  • Angular velocity of ankle change

    Measure of angular velocity of ankle joint during tests using inertial measurement unit

    5 minutes before physical exercise

  • Angular velocity of ankle change

    Measure of angular velocity of ankle joint during tests using inertial measurement unit

    5 minutes after physical exercise

Study Arms (1)

Healthy

EXPERIMENTAL

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

Other: Fatigue (physical exercise)

Interventions

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

Healthy

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, France

Location

Related Publications (1)

  • Dury J, Ravier G, Michel F. Hip Abductor Muscle Fatigue Induces Different Strategies During Disrupted Postural Control. Front Sports Act Living. 2022 Jun 29;4:918402. doi: 10.3389/fspor.2022.918402. eCollection 2022.

Related Links

MeSH Terms

Conditions

Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2021

First Posted

February 11, 2022

Study Start

January 17, 2022

Primary Completion

February 17, 2022

Study Completion

February 17, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations