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Clinical Trials/NCT05815576
NCT05815576
Completed
Not Applicable

Lower Limb (Patho-)Mechanical Joint Contact Forces and Intrinsic Foot Muscle Properties in Subjects With Lateral Ankle Sprain and Chronic Ankle Instability

Université Catholique de Louvain1 site in 1 country72 target enrollmentFebruary 3, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Ankle Instability
Sponsor
Université Catholique de Louvain
Enrollment
72
Locations
1
Primary Endpoint
Lower limb joint angles
Status
Completed
Last Updated
8 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 3, 2023
End Date
February 17, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Sequential
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Lower limb joint angles

Time Frame: 5 minutes after the end of the intervention

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.

Lower limb joint angular velocities

Time Frame: 5 minutes after the end of the intervention

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.

Joint powers

Time Frame: 5 minutes after the end of the intervention

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.

Intrinsic foot muscle area

Time Frame: Baseline

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.

Joint moments

Time Frame: 5 minutes after the end of the intervention

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.

Intrinsic foot muscle thickness

Time Frame: Baseline

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.

Secondary Outcomes

  • Foot and Ankle Activity Measure(Baseline)
  • Navicular drop(Baseline)
  • Electrostimulation current intensity(Immediately after the end of the intervention)
  • Cumberland Ankle Instability Tool(Baseline)
  • Ankle-specific Fear-Avoidance Beliefs Questionnaire(Baseline)
  • Foot muscle strength(Baseline)
  • Foot Posture Index(Baseline)
  • Modified Star Excursion Balance Test(Baseline)
  • Perceived foot fatigue(Immediately after the end of the intervention)
  • Change from baseline in hallux flexion strength after the intervention(Change between baseline and immediately post-intervention)

Study Sites (1)

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