Biomechanics and Intrinsic Foot Muscle Roles in Subjects With Chronic Ankle Instability

Last updated: April 3, 2023
Sponsor: Université Catholique de Louvain
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05815576
B3222022000964
S66498
  • Ages 18-44
  • Male
  • Accepts Healthy Volunteers

Study Summary

The current study involves a prospective interventional study that primarily intends to compare foot joint loadings of participants with chronic ankle instability (CAI) with those of subjects who recovered after an ankle sprain (LAS copers) and healthy controls during running and more challenging tasks. This study further aims to explore the impact of foot muscle properties and fatigue on the same biomechanical outcomes. Therefore, the investigators will recruit 72 participants (24 per group) aged from 18 to 44 years. Each of them will come only once to the CMAL laboratory (UZ Leuven, Pellenberg).

Eligibility Criteria

Inclusion

Three groups of participants : Chronic ankle instability, lateral ankle sprain copers andhealthy controls. INCLUSION CRITERIA:

  1. For all three groups :
  • Physically active male subjects between 18 and 44 years of age
  • Able to run at low speed.
  • For homogeneity purposes, the investigators will only recruit subjects whoperform a regular physical activity on a weekly basis, including competitionparticipation.
  1. Chronic ankle instability :
  • A history of at least one significant ankle sprain that occurred at least 12months before study enrolment, associated with inflammatory symptoms, creating atleast 1 interrupted day of desired physical activity;
  • The most recent injury occurred more than 3 months prior to study enrolment;
  • At least two episodes of giving way in the 6 months prior to study enrolment,recurrent sprain, and/or "feelings of instability"; and
  • Poor disability status according to the Cumberland Ankle Instability Tool (CAIT) (score ≤ 24/30).
  1. Lateral ankle sprain copers :
  • A history of one significant ankle sprain that occurred at least 12 months beforestudy enrolment, associated with inflammatory symptoms, creating at least 1interrupted day of desired physical activity;
  • A return to at least moderate levels of weight-bearing physical activity lessthan 12 months after initial sprain without recurrent injury, episodes of givingway, and/or feelings of instability;
  • Minimal, if any, level of self-reported disability (CAIT score ≥ 28/30); and
  • Minimal, if any, alteration in self-reported function (ADL- and Sport-subscales ≥95%).
  1. Healthy controls :
  • The same inclusion criteria as the LAS coper group, with the exception reportedin the exclusion criteria.

Exclusion

EXCLUSION CRITERIA:

  1. For all three groups :
  • Being younger than 18 years
  • Any medical contraindication to physical exertion,
  • Any systemic or neurological disease,
  • A recent surgery,
  • A difference in leg length of more than 3 cm,
  • Pregnancy,
  • A body mass index higher than 30kg/m² (due to less accurate motion analysis byabsence of anatomical landmarks).
  • LAS copers and controls will also be excluded if: constant or intermittent anklepain, ankle fractures, or surgeries, and recent participation in a physicalrevalidation programme.
  • Healthy participants must never have suffered an inversion trauma resulting indisability.
  1. For healthy controls : the healthy control subjects may not have suffered from anankle sprain.

Study Design

Total Participants: 72
Study Start date:
February 03, 2023
Estimated Completion Date:
February 29, 2024

Connect with a study center

  • UZ Leuven, Pellenberg

    Lubbeek, B-3212
    Belgium

    Active - Recruiting

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