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

NCT05815576 | Completed

• 2 other identifiers: B3222022000964S66498
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

Biomechanical phenomena; Kinetics; Kinematics; Intrinsic foot muscles; CAI; Plantar pressures; Ultrasound

Outcome Measures

Primary Outcomes (10)

• Lower limb joint angles

  Part of "Kinematic data" Unit of measurement: Degrees Measurement tools: Vicon software (data acquisition) + Matlab routine (data processing) Method: Joint angles will be measured based on the position of passive markers placed on participants' anatomical landmarks all over the lower limbs. The position of those markers will be tracked by 10 infrared high-speed cameras that surround the walkway (sampled at 100Hz - type T-10, 1 megapixel, captures 10-bit grayscale using 1120 \* 896 pixels, Vicon Motion System Ltd, Oxford, Metrics, UK). The angular positions of the multiple joints that constitute the lower limb (hip, knee, ankle, chopart, lisfranc and metatarsophalangeal) will be assessed during running, side-cutting and crossing over a small obstacle in the gait laboratory.

  Baseline

• Lower limb joint angles

  Part of "Kinematic data" Unit of measurement: Degrees Measurement tools: Vicon software (data acquisition) + Matlab routine (data processing) Method: Joint angles will be measured based on the position of passive markers placed on participants' anatomical landmarks all over the lower limbs. The position of those markers will be tracked by 10 infrared high-speed cameras that surround the walkway (sampled at 100Hz - type T-10, 1 megapixel, captures 10-bit grayscale using 1120 \* 896 pixels, Vicon Motion System Ltd, Oxford, Metrics, UK). The angular positions of the multiple joints that constitute the lower limb (hip, knee, ankle, chopart, lisfranc and metatarsophalangeal) will be assessed during running, side-cutting and crossing over a small obstacle in the gait laboratory.

  5 minutes after the end of the intervention

• Lower limb joint angular velocities

  Part of "Kinematic data" Unit of measurement: Degrees/second Measurement tool: Vicon software + Matlab routine Method: Joint angular velocities are also assessed based on reflexive markers placed on anatomical landmarks. This outcome evaluates the rate of change of a certain joint angle over time. Joint angular velocities will be assessed during running, side-cutting and crossing over a small obstacle in the gait laboratory.

  Baseline

• Lower limb joint angular velocities

  Part of "Kinematic data" Unit of measurement: Degrees/second Measurement tool: Vicon software + Matlab routine Method: Joint angular velocities are also assessed based on reflexive markers placed on anatomical landmarks. This outcome evaluates the rate of change of a certain joint angle over time. Joint angular velocities will be assessed during running, side-cutting and crossing over a small obstacle in the gait laboratory.

  5 minutes after the end of the intervention

• Joint moments

  Part of "Kinetic data" Unit of measurement: Newton-meter Measurement tools: Pressure plate + Force plate + Vicon software + Matlab routine Methods: Joint moments will be determined by coupling kinematic data (joint position and velocities) with plantar pressure data from a specially designed pressure plate (sampled at 200Hz, Footscan, dimension 0.5m x 0.4m, 4096 sensors, 2.8 sensors/cm², RsScan International, Olen, Belgium) embedded in the middle of the runway and placed on top of a force plate (sampled at 1000Hz, Advanced Mechanical Technology Inc., Watertown, MA, USA). Kinetic data will be assessed while running, side-cutting and crossing over a small obstacle in the gait laboratory.

  Baseline

• Joint moments

  Part of "Kinetic data" Unit of measurement: Newton-meter Measurement tools: Pressure plate + Force plate + Vicon software + Matlab routine Methods: Joint moments will be determined by coupling kinematic data (joint position and velocities) with plantar pressure data from a specially designed pressure plate (sampled at 200Hz, Footscan, dimension 0.5m x 0.4m, 4096 sensors, 2.8 sensors/cm², RsScan International, Olen, Belgium) embedded in the middle of the runway and placed on top of a force plate (sampled at 1000Hz, Advanced Mechanical Technology Inc., Watertown, MA, USA). Kinetic data will be assessed while running, side-cutting and crossing over a small obstacle in the gait laboratory.

  5 minutes after the end of the intervention

• Joint powers

  Part of "Kinetic data" Unit of measurement: Watt Measurement tools: Pressure plate + Vicon software + Matlab routine Methods: Joint moments will be determined by coupling kinematic data (joint position and velocities) with plantar pressure data from a specially designed pressure plate (sampled at 200Hz, Footscan, dimension 0.5m x 0.4m, 4096 sensors, 2.8 sensors/cm², RsScan International, Olen, Belgium) embedded in the middle of the runway and placed on top of a force plate (sampled at 1000Hz, Advanced Mechanical Technology Inc., Watertown, MA, USA). Kinetic data will be assessed while running, side-cutting and crossing over a small obstacle in the gait laboratory.

  Baseline

• Joint powers

  Part of "Kinetic data" Unit of measurement: Watt Measurement tools: Pressure plate + Vicon software + Matlab routine Methods: Joint moments will be determined by coupling kinematic data (joint position and velocities) with plantar pressure data from a specially designed pressure plate (sampled at 200Hz, Footscan, dimension 0.5m x 0.4m, 4096 sensors, 2.8 sensors/cm², RsScan International, Olen, Belgium) embedded in the middle of the runway and placed on top of a force plate (sampled at 1000Hz, Advanced Mechanical Technology Inc., Watertown, MA, USA). Kinetic data will be assessed while running, side-cutting and crossing over a small obstacle in the gait laboratory.

  5 minutes after the end of the intervention

• Intrinsic foot muscle thickness

  Unit of measurement: cm Methods: The thickness of five intrinsic foot muscles (abductor hallucis, flexor digitorum brevis, flexor hallucis, quadratus plantae and abductor digiti minimi) will be measured on images obtained using ultrasonography. To obtain those images, the investigators will scan the muscles in a longitudinal view.

  Baseline

• Intrinsic foot muscle area

  Unit of measurement: cm² (cm square) Methods: The area of five intrinsic foot muscles (abductor hallucis, flexor digitorum brevis, flexor hallucis, quadratus plantae and abductor digiti minimi) will be measured on images obtained using ultrasonography. To obtain those images, the investigators will scan the muscles in a transversal view.

  Baseline

Secondary Outcomes (16)

• Cumberland Ankle Instability Tool

  Baseline

• Foot and Ankle Activity Measure

  Baseline

• Ankle-specific Fear-Avoidance Beliefs Questionnaire

  Baseline

• Foot muscle strength

  Baseline

• Change from baseline in hallux flexion strength after the intervention

  Change between baseline and immediately post-intervention

Study Arms (2)

Intrinsic foot muscle fatigue

EXPERIMENTAL

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).

Behavioral: Intrinsic foot muscle fatigue

No intrinsic foot muscle fatigue

NO INTERVENTION

No fatigue of the intrinsic foot muscles.

Interventions

Intrinsic foot muscle fatigue 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).

Intrinsic foot muscle fatigue

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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).
• 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%).
• Healthy controls :

You may not qualify if:

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

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• UZ Leuven, campus Pellenberg (Belgium): collaborator

Study Sites (1)

UZ Leuven, Pellenberg

Lubbeek, B-3212, Belgium

Location

Study Officials

• Kevin Deschamps

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

  PRINCIPAL INVESTIGATOR

• Christine Detrembleur

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data will be coded (pseudonymization). The subject's name or other identifiers will be stored separately from their research data and replaced with a unique code to create a new identity for the subject. The outcomes assessor will be blind for participants' injury status for the following : * while conducting kinematic and kinetic data processing, * while performing muscle size measurements on the ultrasound images, * while performing statistical analysis (for all outcomes) There will be no blinding while scoring the following outcomes (because these scores are immediately determined in the presence of the participant) : * Foot muscle strength, * Foot posture index, * Navicular drop, * Modified Star Excursion Balance Test,
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention is a fatigue protocol of the intrinsic foot muscles. Only subjects with chronic ankle instability will undergo this fatigue protocol. Participants with chronic ankle instability will perform the movement analysis first without and then with foot muscle fatigue.

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: April 18, 2023
• Study Start: February 3, 2023
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)