NCT06687954

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

November 3, 2024

Last Update Submit

February 21, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    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.

    Up to 28 weeks

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Camilo Jose Cela

Villanueva de la Cañada, Madrid, 28692, Spain

Location

Study Officials

  • María Benito

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
58 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 14, 2024

Study Start

December 27, 2023

Primary Completion

May 16, 2024

Study Completion

July 22, 2024

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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)

Locations