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临床试验/NCT05815576
NCT05815576已完成不适用

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 Louvain2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Lower limb joint angles

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Screening
盲法
Single (Outcomes Assessor)

盲法说明

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,

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Lower limb joint angles

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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