Ankle DiseaseTOBEMGNCT06114654
Gluteal Musculature Activation to Improve Ankle Stability
An observational study of Ankle Disease and Muscle Weakness, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
The goal of this observational study is to to evaluate and correlate muscle activation in the gluteal musculature and ankle stability in a healthy population. The main question it aims to answer is: Is there a significant positive correlation between gluteal muscle activation and ankle stability? Participants will… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Disease, Muscle Weakness
- What is being tested?
- Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 30 Sep 2023
- Phase
- Observational
- 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
Study population: Health students from the Faculty of Medicine and Health Sciences of the Rovira i Virgili University.
Who may be able to join
- To be between 18 and 35 years of age.
- To sign the informed consent form.
- Failure to meet the exclusion criteria.
Who cannot join
- To have an injury at the time of selection.
- To have psychological and/or psychiatric illnesses.
- To take anticoagulants, to have an infectious process.
- To have a heart disease.
- To be hypersensitive to pain.
- To have skin infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gluteal Musculature Activation to Improve Ankle Stability: a Cross-sectional Observational Study
The goal of this observational study is to to evaluate and correlate muscle activation in the gluteal musculature and ankle stability in a healthy population. The main question it aims to answer is: Is there a significant positive correlation between gluteal muscle activation and ankle stability?
Participants will complete questionnaires on the functionality of foot and ankle pathologies related to their daily life and sports activities, and perform specific physical tests to assess muscle strength, ankle stability, and activation of the lower extremity musculature.
Read the detailed description
The main outcomes were the muscle activation (gluteus maximus, gluteus medius, tibialis anterior, and peroneus longus) of both limbs during a Single Leg Stance test and a Hurdle Step test (Check Your Motion, Albacete, Spain). Muscle activation was assessed using surface electromyography, and the results will be described as a percentage of Maximum Isometric Voluntary Contraction (%MVIC). Ankle stability was evaluated according to the criteria established by Perrot using a force platform (Dynamic Walkway P6000, BTS Bioengineering, Milan, Italy).
There are no previous studies evaluating a possible correlation between gluteus maximus muscle activity and ankle stabilization capacity. Therefore, a sample size calculation was performed with the aim of detecting a strong correlation as statistically significant (r=0.5) according to the criteria of Hopkins et al [33]. The G*Power 3.1 program was used to calculate the sample size. The statistical test used was "Correlation: Bivariate Normal Model", the type of power analysis was "A priori: compute required sample size - given alpha, power and effect size". An error α=0.05 and a statistical power of 0.80 (β=0.20) was used. The result of the test was 29 subjects required to perform this research.
The study investigators will sign a data confidentiality sheet where they commit to use the data with appropriate confidentiality. In addition, after analyzing the results, the participant's face will be hidden so that he/she cannot be recognized.
The data will be collected on a form designed for this purpose and will be entered into a database created with the Microsoft Office Excel® 2021 program, in a URV system subject to the security measures of the National Security Scheme, always in areas where only the research staff of this project can access. Subsequently, the SPSS program (Statistical Package for the Social Sciences) version 26.0 for Windows® will be used to analyze the data.
The normality of all variables will be examined using the Saphiro Wilk statistical test. Descriptive statistics for all variables will be expressed as mean (standard deviation) if the variable follows a normal distribution and as median (interquartile range) if the variable does not follow a normal distribution. Subsequently, correlation analysis will be performed using Pearson's correlation test (if both variables are normal) or Spearman's Rho (if either variable does not follow a normal distribution). Correlations will be classified as weak (r=0.1), moderate (r=0.3), strong (r=0.5), large (r=0.7) or very large (r=0.9) [33]. Correlations will be described as statistically significant if the p-value is less than 0.05. If the correlation coefficient is statistically significant, the coefficient of determination (R2) will be calculated. Bonferroni correction for multiple comparisons will be applied based on the correlations finally evaluated.
- Conditions
- Ankle Disease, Muscle Weakness
- Being tested
- Physical Therapy
- Keywords
- biomechanics, electromyography, ankle stability, gluteal musculature
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyBehavioural
Specific physical tests to assess muscle strength, ankle stability and activation of the lower extremity musculature: Single Leg Stance Test, Hurdle Step test and Single leg vertical jump.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Physiotherapy students of the Rovira i Virgili University aged between 18 and 35 years enrolled during the academic year 2022-2023. All participants were allowed three practice trials for each test. Consistent feedback was provided throughout to ensure proper technique. Electrodes were placed to assess muscle activity according to SENIAM recommendations in gluteus medius, gluteus maximus, tibialis anterior and peroneus longus. After electrode placement, a maximal isometric strength test (MVIC) was performed for each muscle to normalize the electromyographic data. During this MVIC test, the maximum isometric force was measured using the Chronojump Boscosystem force gauge. Following this, ankle stability evaluation tests were performed. The Single Leg Stance Test, the Hurdle Step test and finally the Single leg vertical jump will be performed. Receives: Behavioral: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activation (%MVIC)
This was measured with wireless electromyography sensors electromiografía (BTS FreeEMG 1000, BTS Bioengineering, Milan, Italy).
Measured: 1 year
Ankle stability
This was measured with force platform (Dynamic Walkway P6000, BTS Bioengineering, Milan, Italy).
Measured: 1 year
Secondary outcomes (6)
Aye
Years
Measured: 1 year
Gender
Female or male
Measured: 1 year
Height
Centimeters
Measured: 1 year
Body weight
Kilograms
Measured: 1 year
Ankle functionality
This was measured with a Foot and Ankle Ability Measures questionnaire. It consists of 9 items, each item has a certain score and the sum of these should give a result between 0 and 30 points. If the result is ≤ 27 points, it indicates ankle instability.
Measured: 1 year
Maximum isometric muscle strength
This was measured with a force gauge, Chronojump Boscosystem
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jan 2022
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle DiseaseStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CRISTINA ADILLÓN, University Rovira i Virgili
- Investigators
- Cristina Adillón, PhD, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114654
- Sponsor's protocol ID
- 074/2022
- Acronym
- TOBEMG
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluteal Musculature Activation to Improve Ankle Stability: a Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT06114654
- Acronym / sponsor ID
- TOBEMG / 074/2022
- Conditions
- Ankle Disease, Muscle Weakness
- Keywords
- biomechanics, electromyography, ankle stability, gluteal musculature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 2 Nov 2023 (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.
The goal of this observational study is to to evaluate and correlate muscle activation in the gluteal musculature and ankle stability in a healthy population. The main question it aims to answer is: Is there a significant positive correlation between gluteal muscle activation and ankle stability?
Participants will complete questionnaires on the functionality of foot and ankle pathologies related to their daily life and sports activities, and perform specific physical tests to assess muscle strength, ankle stability, and activation of the lower extremity musculature.
Detailed description
The main outcomes were the muscle activation (gluteus maximus, gluteus medius, tibialis anterior, and peroneus longus) of both limbs during a Single Leg Stance test and a Hurdle Step test (Check Your Motion, Albacete, Spain). Muscle activation was assessed using surface electromyography, and the results will be described as a percentage of Maximum Isometric Voluntary Contraction (%MVIC). Ankle stability was evaluated according to the criteria established by Perrot using a force platform (Dynamic Walkway P6000, BTS Bioengineering, Milan, Italy).
There are no previous studies evaluating a possible correlation between gluteus maximus muscle activity and ankle stabilization capacity. Therefore, a sample size calculation was performed with the aim of detecting a strong correlation as statistically significant (r=0.5) according to the criteria of Hopkins et al [33]. The G*Power 3.1 program was used to calculate the sample size. The statistical test used was "Correlation: Bivariate Normal Model", the type of power analysis was "A priori: compute required sample size - given alpha, power and effect size". An error α=0.05 and a statistical power of 0.80 (β=0.20) was used. The result of the test was 29 subjects required to perform this research.
The study investigators will sign a data confidentiality sheet where they commit to use the data with appropriate confidentiality. In addition, after analyzing the results, the participant's face will be hidden so that he/she cannot be recognized.
The data will be collected on a form designed for this purpose and will be entered into a database created with the Microsoft Office Excel® 2021 program, in a URV system subject to the security measures of the National Security Scheme, always in areas where only the research staff of this project can access. Subsequently, the SPSS program (Statistical Package for the Social Sciences) version 26.0 for Windows® will be used to analyze the data.
The normality of all variables will be examined using the Saphiro Wilk statistical test. Descriptive statistics for all variables will be expressed as mean (standard deviation) if the variable follows a normal distribution and as median (interquartile range) if the variable does not follow a normal distribution. Subsequently, correlation analysis will be performed using Pearson's correlation test (if both variables are normal) or Spearman's Rho (if either variable does not follow a normal distribution). Correlations will be classified as weak (r=0.1), moderate (r=0.3), strong (r=0.5), large (r=0.7) or very large (r=0.9) [33]. Correlations will be described as statistically significant if the p-value is less than 0.05. If the correlation coefficient is statistically significant, the coefficient of determination (R2) will be calculated. Bonferroni correction for multiple comparisons will be applied based on the correlations finally evaluated.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Behavioral: Physical TherapyPhysiotherapy students of the Rovira i Virgili University aged between 18 and 35 years enrolled during the academic year 2022-2023. All participants were allowed three practice trials for each test. Consistent feedback was provided throughout to ensure proper technique. Electrodes were placed to assess muscle activity according to SENIAM recommendations in gluteus medius, gluteus maximus, tibialis anterior and peroneus longus. After electrode placement, a maximal isometric strength test (MVIC) was performed for each muscle to normalize the electromyographic data. During this MVIC test, the maximum isometric force was measured using the Chronojump Boscosystem force gauge. Following this, ankle stability evaluation tests were performed. The Single Leg Stance Test, the Hurdle Step test and finally the Single leg vertical jump will be performed. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Health students from the Faculty of Medicine and Health Sciences of the Rovira i Virgili University.
Key inclusion criteria (3 listed)
- To be between 18 and 35 years of age.
- To sign the informed consent form.
- Failure to meet the exclusion criteria.
Key exclusion criteria (6 listed)
- To have an injury at the time of selection.
- To have psychological and/or psychiatric illnesses.
- To take anticoagulants, to have an infectious process.
- To have a heart disease.
- To be hypersensitive to pain.
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 |
|---|---|---|
| Physical TherapySpecific physical tests to assess muscle strength, ankle stability and activation of the lower extremity musculature: Single Leg Stance Test, Hurdle Step test and Single leg vertical jump. | Behavioural | Participants |
Primary outcome
Muscle activation (%MVIC)
Time frame: 1 year
This was measured with wireless electromyography sensors electromiografía (BTS FreeEMG 1000, BTS Bioengineering, Milan, Italy).
Ankle stability
Time frame: 1 year
This was measured with force platform (Dynamic Walkway P6000, BTS Bioengineering, Milan, Italy).
6 secondary outcomes
Aye
Time frame: 1 year
Gender
Time frame: 1 year
Height
Time frame: 1 year
Body weight
Time frame: 1 year
Ankle functionality
Time frame: 1 year
Maximum isometric muscle strength
Time frame: 1 year
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 7 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Cristina Adillón, PhD principal investigator
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Disease and Muscle Weakness, run by University Rovira i Virgili at 1 site in Spain.
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 3 inclusion and 6 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 7 Nov 2023. 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 Spain. 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?
Muscle activation (%MVIC) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.