Chronic Ankle Instability, CAINCT06687954
Activation of the Ankle Musculature in Basketball Players With Chronic Ankle Instability
An observational study of Chronic Ankle Instability, CAI, run by Camilo Jose Cela University at 1 site in Spain.
Trial summary
Background: Lateral ankle sprain (LAS) is a very common injury in the general population and in the world of basketball in particular, initially Its recurrence rate is very high, generating chronic ankle instability (CAI), accompanied by decreased muscle activation in the ankle musculature and lack of motor control. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability, CAI
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 27 Dec 2023to 22 Jul 2024
- How long will I take part?
- 58 Days
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants were selected through non-probabilistic sampling in several amateur basketball teams in the Autonomous Community of Madrid. Both male and female basketball players with and without CAI were recruited A total of 58 subjects participated in the study with a mean age of 29.19±6.98 years a weight of 66,46±7,23 Kilograms and a height of 1,74±0,07 meters, with a body mass index (BMI), obtained by dividing weight by height squared (kg/m^2), average of 21.87±1.64, with no differences between the two groups.
Who may be able to join
- Volunteers aged 18-45 years
- Physical activity level of at least 3 hours per week
- First sprain more than one year ago
- No sprain in the 6 weeks prior to the test
- Scored ≥ 11 on the functional ankle instability identification questionnaire.
Who cannot join
- Having undergone lower limb surgery and/or diseases that may influence neuromuscular control
- Suffering from any type of incapacity to complete the proposed sporting gesture
- Patients without CAI should not have a history of ankle sprains.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Activation of the Ankle Musculature During the Sporting Gesture in Basketball Players With Chronic Ankle Instability A Case Control Study
Background: Lateral ankle sprain (LAS) is a very common injury in the general population and in the world of basketball in particular, initially Its recurrence rate is very high, generating chronic ankle instability (CAI), accompanied by decreased muscle activation in the ankle musculature and lack of motor control. The aim of this study is to evaluate the activation of the peroneal musculature during the sports gestures of layup and free throw, and the motor control of both in healthy patients and in patients with CAI.
Method: Using a surface electromyography study (sEMG) of 58 basketball players of amateur teams, 36 women and 22 men, with and without CAI, in the peroneus lateralis longus (PLL) and peroneus lateralis brevis musculature (PLB).
Read the detailed description
Design A case-control study was conducted. The entire procedure was carried out for human experimentation. The case control study followed the CONSORT guidelines.
Meassurement Muscle activity was recorded using an mDurance R surface EMG system (mDurance Solutions SL, Granada, Spain), a portable sEMG system that consists of three parts(i) A Shimmer3 EMG unit (Realtime Technologies Ltd., Dublin, Ireland), which is a bipolar sEMG sensor for muscle activity acquisition. Each Shimmer sensor is composed of two sEMG channels, with a sampling rate of 104 Hz. (ii) The mDurance mobile application (Android), which receives data from the Shimmer unit and sends it to a cloud service(iii) The mDurance cloud service, where the sEMG signals were stored, filtered and analysed, and reports were generated.
Surface electrode placement was performed following the recommendations of Surface EMG for Non-Invasive Muscle Assessment (SENIAM),bilaterally and parallel to the direction of the muscle fibres.
Protocol Firstly, anthropometric variables and personal information, training hours of the participants as well as ankle and lower limb injuries were collected through a Microsoft Forms.
In this study, changes in the sEMG signal of PLL and PLB in patients with and without CAI were investigated in the performance of various basketball-specific sport gestures . These changes in signal amplitude (root mean square) reflect the level of activation during the sporting gesture in the PLL and PLB muscles.
Maximal voluntary contraction (MVC) measurement First, participants were asked to perform a MVC, both PLL and PLB towards eversion and in the supine position, from the inversion position. Three maximal attempts of 5 seconds each, separated by 1 minute of rest, were performed. The best performance was chosen for statistical analysis.
Participants were verbally encouraged as the investigators conducted the assessment. The purpose of this test was to compare maximal amplitudes with submaximal amplitudes.
EMG recording in sport gesture The participants first warmed up for 10 minutes on the court, after which they were ready to shoot 3 series of 18 free throws each, with a rest of 35 seconds between each of them. The first sport gesture measured was the free throw, that is a sporting gesture that is always performed from a distance of 4.57 metres from the basket, which is 305 cm high. They were always performed with the same ball, with a perimeter size of 74.93 - 78 cm in the case of the male category and 72.4 - 73.7 cm in the case of the female category, as per National Basketball Association standards. To avoid fatigue, each shot was separated by a 10-15 second break and each series by 35 seconds. All participants in the study performed the throws without instructions or instructions on how to execute each personal routine.
This was followed by 1 series of 10 right-handed basket layups(first step starting with the right leg and second starting with the left leg) and another series of 10 left-handed basket layups (first step starting with the left leg and second starting with the right leg). In between, the players were asked to rest for 5 minutes.
The drive to the basket is a sporting gesture that consists of taking 3 steps towards the basket, (i) a short step towards the basket, (ii) a long step towards the basket, and (iii) a final jump.
- Conditions
- Chronic Ankle Instability, CAI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Players of basketball team without CAI: this players have no history of ankle sprain | |
| Case | Players of basketball team with CAI: scored ≥ 11 on the functional ankle instability identification questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the different activation patron of the peroneal muscles (electromyograpic analysis), in the different phases of the layup gesture , in patients with CAI and without CAI.
As a primary outcome measure, the investigators evaluated the difference in the activation of the PLL and PLB muscles both in patients suffering from CAI and in those who do not suffer from it, during the development of the layup.
Measured: Up to 28 weeks
Secondary outcomes (1)
Evaluation of moment of greatest activation (electromyographic evaluation) of the peroneal muscles, and motor control in layup gesture, in patients with CAI and without CAI.
As secondary outcome measure:
- To evaluate the moment of greatest solicitation of these muscles during both layup gesture in healthy patients and to assess the response of the peroneal muscles at the same moment in patients with CAI.
- To assess the motor control in CAI patients at the moment of greatest solicitation of the ankle and their possible response to a possible injury gesture.
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start27 Dec 2023
- Primary completion16 May 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle Instability, CAIStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
- Target duration
- 58 Days
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María Benito, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687954
- Sponsor's protocol ID
- 15_24_CQSI
- Status last verified
- Feb 2025
- First submitted
- 3 Nov 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers participated by collecting data from the sample, but at no time did they have access to the personal data of said sample, only to the code that represented each of them (always coded information)
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of the Ankle Musculature During the Sporting Gesture in Basketball Players With Chronic Ankle Instability A Case Control Study
- ClinicalTrials.gov ID
- NCT06687954
- Acronym / sponsor ID
- 15_24_CQSI
- Conditions
- Chronic Ankle Instability, CAI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 14 Nov 2024 (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.
Background: Lateral ankle sprain (LAS) is a very common injury in the general population and in the world of basketball in particular, initially Its recurrence rate is very high, generating chronic ankle instability (CAI), accompanied by decreased muscle activation in the ankle musculature and lack of motor control. The aim of this study is to evaluate the activation of the peroneal musculature during the sports gestures of layup and free throw, and the motor control of both in healthy patients and in patients with CAI.
Method: Using a surface electromyography study (sEMG) of 58 basketball players of amateur teams, 36 women and 22 men, with and without CAI, in the peroneus lateralis longus (PLL) and peroneus lateralis brevis musculature (PLB).
Detailed description
Design A case-control study was conducted. The entire procedure was carried out for human experimentation. The case control study followed the CONSORT guidelines.
Meassurement Muscle activity was recorded using an mDurance R surface EMG system (mDurance Solutions SL, Granada, Spain), a portable sEMG system that consists of three parts(i) A Shimmer3 EMG unit (Realtime Technologies Ltd., Dublin, Ireland), which is a bipolar sEMG sensor for muscle activity acquisition. Each Shimmer sensor is composed of two sEMG channels, with a sampling rate of 104 Hz. (ii) The mDurance mobile application (Android), which receives data from the Shimmer unit and sends it to a cloud service(iii) The mDurance cloud service, where the sEMG signals were stored, filtered and analysed, and reports were generated.
Surface electrode placement was performed following the recommendations of Surface EMG for Non-Invasive Muscle Assessment (SENIAM),bilaterally and parallel to the direction of the muscle fibres.
Protocol Firstly, anthropometric variables and personal information, training hours of the participants as well as ankle and lower limb injuries were collected through a Microsoft Forms.
In this study, changes in the sEMG signal of PLL and PLB in patients with and without CAI were investigated in the performance of various basketball-specific sport gestures . These changes in signal amplitude (root mean square) reflect the level of activation during the sporting gesture in the PLL and PLB muscles.
Maximal voluntary contraction (MVC) measurement First, participants were asked to perform a MVC, both PLL and PLB towards eversion and in the supine position, from the inversion position. Three maximal attempts of 5 seconds each, separated by 1 minute of rest, were performed. The best performance was chosen for statistical analysis.
Participants were verbally encouraged as the investigators conducted the assessment. The purpose of this test was to compare maximal amplitudes with submaximal amplitudes.
EMG recording in sport gesture The participants first warmed up for 10 minutes on the court, after which they were ready to shoot 3 series of 18 free throws each, with a rest of 35 seconds between each of them. The first sport gesture measured was the free throw, that is a sporting gesture that is always performed from a distance of 4.57 metres from the basket, which is 305 cm high. They were always performed with the same ball, with a perimeter size of 74.93 - 78 cm in the case of the male category and 72.4 - 73.7 cm in the case of the female category, as per National Basketball Association standards. To avoid fatigue, each shot was separated by a 10-15 second break and each series by 35 seconds. All participants in the study performed the throws without instructions or instructions on how to execute each personal routine.
This was followed by 1 series of 10 right-handed basket layups(first step starting with the right leg and second starting with the left leg) and another series of 10 left-handed basket layups (first step starting with the left leg and second starting with the right leg). In between, the players were asked to rest for 5 minutes.
The drive to the basket is a sporting gesture that consists of taking 3 steps towards the basket, (i) a short step towards the basket, (ii) a long step towards the basket, and (iii) a final jump.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 58 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Players of basketball team without CAI: this players have no history of ankle sprain |
| Case | – | –Players of basketball team with CAI: scored ≥ 11 on the functional ankle instability identification questionnaire. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants were selected through non-probabilistic sampling in several amateur basketball teams in the Autonomous Community of Madrid. Both male and female basketball players with and without CAI were recruited A total of 58 subjects participated in the study with a mean age of 29.19±6.98 years a weight of 66,46±7,23 Kilograms and a height of 1,74±0,07 meters, with a body mass index (BMI), obtained by dividing weight by height squared (kg/m^2), average of 21.87±1.64, with no differences between the two groups.
Key inclusion criteria (5 listed)
- Volunteers aged 18-45 years
- Physical activity level of at least 3 hours per week
- First sprain more than one year ago
- No sprain in the 6 weeks prior to the test
- Scored ≥ 11 on the functional ankle instability identification questionnaire.
Key exclusion criteria (3 listed)
- Having undergone lower limb surgery and/or diseases that may influence neuromuscular control
- Suffering from any type of incapacity to complete the proposed sporting gesture
- Patients without CAI should not have a history of ankle sprains.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of the different activation patron of the peroneal muscles (electromyograpic analysis), in the different phases of the layup gesture , in patients with CAI and without CAI.
Time frame: Up to 28 weeks
As a primary outcome measure, the investigators evaluated the difference in the activation of the PLL and PLB muscles both in patients suffering from CAI and in those who do not suffer from it, during the development of the layup.
1 secondary outcome
Evaluation of moment of greatest activation (electromyographic evaluation) of the peroneal muscles, and motor control in layup gesture, in patients with CAI and without CAI.
Time frame: Up to 28 weeks
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 24 Feb 2025.
- Individual participant dataSharing planned: No. Other researchers participated by collecting data from the sample, but at no time did they have access to the personal data of said sample, only to the code that represented each of them (always coded information)
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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.
María Benito principal investigator
Associate Professor
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 Chronic Ankle Instability, CAI, run by Camilo Jose Cela University 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 5 inclusion and 3 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 24 Feb 2025. 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?
Measurement of the different activation patron of the peroneal muscles (electromyograpic analysis), in the different phases of the layup gesture , in patients with CAI and without CAI. (time frame: Up to 28 weeks). 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 24 Feb 2025.