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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Spain1 site
  • Universidad Camilo Jose Cela

    Villanueva de la Cañada, Madrid, 28692

Other trials in Spain

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06687954
Study groupRoleWhat they receive
ControlPlayers of basketball team without CAI: this players have no history of ankle sprain
CasePlayers 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.

  1. 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)
  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:

    1. 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.
    2. 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.

  1. First posted14 Nov 2024
  2. Study start27 Dec 2023
  3. Primary completion16 May 2024
  4. Study completion22 Jul 2024

Resources

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
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)

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.

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