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

NCT ID: NCT05815576

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2025-02-17

Brief 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).

Conditions

Chronic Ankle Instability; Lateral Ankle Sprain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Intrinsic foot muscle fatigue

The fatigue protocol will consist of repeated movements of doming (short foot exercise), combined with electrostimulation of the abductor hallucis muscle, while standing on both feet. Participants will be familiarized with doming and electrostimulation during five minutes. They will then have a rest period of at least 5 minutes The electrostimulation electrodes will be placed behind the head of the first metatarsal bone and in front of the medial tubercule of the calcaneus, on the most affected side of subjects with chronic ankle instability (according to CAIT questionnaire scores).

Group Type: EXPERIMENTAL

Intrinsic foot muscle fatigue

Intervention Type: BEHAVIORAL

Electrostimulation will be delivered through electrodes placed on the abductor hallucis (NOT invasive).

The investigators plan 4 sets of 4 minutes of repeated contractions (electrostimulation + voluntary contraction).

No intrinsic foot muscle fatigue

No fatigue of the intrinsic foot muscles.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intrinsic foot muscle fatigue

Electrostimulation will be delivered through electrodes placed on the abductor hallucis (NOT invasive).

The investigators plan 4 sets of 4 minutes of repeated contractions (electrostimulation + voluntary contraction).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 who perform a regular physical activity on a weekly basis, including competition participation.

2. Chronic ankle instability :

• A history of at least one significant ankle sprain that occurred at least 12 months before study enrolment, associated with inflammatory symptoms, creating at least 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).

3. Lateral ankle sprain copers :

• A history of one significant ankle sprain that occurred at least 12 months before study enrolment, associated with inflammatory symptoms, creating at least 1 interrupted day of desired physical activity;
• A return to at least moderate levels of weight-bearing physical activity less than 12 months after initial sprain without recurrent injury, episodes of giving way, 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%).

4. Healthy controls :

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 by absence of anatomical landmarks).
• LAS copers and controls will also be excluded if: constant or intermittent ankle pain, ankle fractures, or surgeries, and recent participation in a physical revalidation programme.
• Healthy participants must never have suffered an inversion trauma resulting in disability.

2. For healthy controls : the healthy control subjects may not have suffered from an ankle sprain.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

UZ Leuven, campus Pellenberg (Belgium)

UNKNOWN

Sponsor Role: collaborator

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Deschamps

Role: PRINCIPAL_INVESTIGATOR

Musculoskeletal Rehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven

Christine Detrembleur

Role: PRINCIPAL_INVESTIGATOR

Neuro Musculo Skeletal Lab (NMSK), IREC, SSS, UCLouvain

Locations

UZ Leuven, Pellenberg

Lubbeek, , Belgium

Countries

Belgium

Other Identifiers

S66498

Identifier Type: OTHER

Identifier Source: secondary_id

B3222022000964

Identifier Type: -

Identifier Source: org_study_id