Last updated: April 3, 2023
Sponsor: Université Catholique de Louvain
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT05815576
B3222022000964
S66498
Ages 18-44 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Three groups of participants : Chronic ankle instability, lateral ankle sprain copers andhealthy controls. INCLUSION CRITERIA:
- 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.
- 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).
- 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%).
- Healthy controls :
- The same inclusion criteria as the LAS coper group, with the exception reportedin the exclusion criteria.
Exclusion
EXCLUSION CRITERIA:
- 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.
- 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
BelgiumActive - Recruiting
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