FatigueHIASNCT05236816
Relationship Between Hip Abductor Strength and Ankle Stability
A study testing Fatigue (physical exercise) in people with Fatigue, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Fatigue (physical exercise)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2022to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
- Conditions
- Fatigue
- Being tested
- Fatigue (physical exercise)
- Keywords
- Balance, Ankle, Destabilization, Prevention, Hip fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue (physical exercise)Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Fatigue (physical exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 minutes after physical exercise
Frontal inclination of ankle change
Measure of accelerations of ankle joint during tests using inertial measurement unit
Measured: 5 minutes before physical exercise
Frontal inclination of ankle change
Measure of accelerations of ankle joint during tests using inertial measurement unit
Measured: 5 minutes after physical exercise
SEBT performances change
Performances (distance in cm) attempted in each direction of the dynamic postural test
Measured: 5 minutes before physical exercise
SEBT performances change
Performances (distance in cm) attempted in each direction of the dynamic postural test
Measured: 5 minutes after physical exercise
Hip abductor strength change
Measure of maximal isometric strength with a S-shape force transducer
Measured: 5 minutes before physical exercise
Hip abductor strength change
Measure of maximal isometric strength with a S-shape force transducer
Measured: 5 minutes after physical exercise
Angular velocity of ankle change
Measure of angular velocity of ankle joint during tests using inertial measurement unit
Measured: 5 minutes before physical exercise
Angular velocity of ankle change
Measure of angular velocity of ankle joint during tests using inertial measurement unit
Measured: 5 minutes after physical exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start17 Jan 2022
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236816
- Sponsor's protocol ID
- 2021/655
- Acronym
- HIAS
- Status last verified
- Sep 2024
- First submitted
- 17 Dec 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35847456
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Hip Abductor Strength and Ankle Stability
- ClinicalTrials.gov ID
- NCT05236816
- Acronym / sponsor ID
- HIAS / 2021/655
- Conditions
- Fatigue
- Keywords
- Balance, Ankle, Destabilization, Prevention, Hip fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Healthy |
Primary outcome
Surface Electromyography intensity change
Time frame: 5 minutes before physical exercise
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
Surface Electromyography intensity change
Time frame: 5 minutes after physical exercise
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
Frontal inclination of ankle change
Time frame: 5 minutes before physical exercise
Measure of accelerations of ankle joint during tests using inertial measurement unit
Frontal inclination of ankle change
Time frame: 5 minutes after physical exercise
Measure of accelerations of ankle joint during tests using inertial measurement unit
SEBT performances change
Time frame: 5 minutes before physical exercise
Performances (distance in cm) attempted in each direction of the dynamic postural test
SEBT performances change
Time frame: 5 minutes after physical exercise
Performances (distance in cm) attempted in each direction of the dynamic postural test
Hip abductor strength change
Time frame: 5 minutes before physical exercise
Measure of maximal isometric strength with a S-shape force transducer
Hip abductor strength change
Time frame: 5 minutes after physical exercise
Measure of maximal isometric strength with a S-shape force transducer
Angular velocity of ankle change
Time frame: 5 minutes before physical exercise
Measure of angular velocity of ankle joint during tests using inertial measurement unit
Angular velocity of ankle change
Time frame: 5 minutes after physical exercise
Measure of angular velocity of ankle joint during tests using inertial measurement unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 35847456Dury 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.
- Hip Abductor Muscle Fatigue Induces Different Strategies During Disrupted Postural ControlLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue (physical exercise) in people with Fatigue, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface Electromyography intensity change (time frame: 5 minutes before physical exercise). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05236816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.