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

Not Applicable

Recruiting

• Conditions: Lateral Ankle Sprain; Chronic Ankle Instability
• Interventions: Behavioral: Intrinsic foot muscle fatigue

• Registration Number: NCT05815576
• Lead Sponsor: Université Catholique de Louvain

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-23
• Study Start: 2023-02-03
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intrinsic foot muscle fatigue	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).

Primary Outcome Measures

Name	Time	Method
Lower limb joint angles	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Foot and Ankle Activity Measure	Baseline	This questionnaire assesses the level of self-reported functional limitations (higher scores indicate less limitations).; Score ranging from 0 to 100%; The FAAM is valid, reliable and responsive to change. It has been validated in French and Dutch. It contains two subscales: Activity of Daily Life (ADL) and Sports. A "Quick" version has shown strong concurrent validity with the full-length FAAM.; This is an inclusion questionnaire
Navicular drop	Baseline	Unit of measurement: cm; The investigators will assess navicular drop as the difference in distance between the navicular tuberosity to the ground from sitting to double-limb stance
Electrostimulation current intensity	Immediately after the end of the intervention	NB: Same as above; Unit of measurement: mA (milli-amperes).; Every 4 minutes, electrostimulation current intensity will be reported during the foot muscle fatigue protocol.; NB: This current intensity should gradually increase during the fatigue protocol as there is a habituation phenomenon. In other words, constant intensity produces decreasing discomfort.; The foot muscle fatigue protocol lasts 16 minutes. Time frame 16 minutes is thus equal to "immediately post-intervention".
Cumberland Ankle Instability Tool	Baseline	This questionnaire assesses the level of perceived instability (higher scores indicate less self-reported instability).; Scores ranging from 0 to 30.; The CAIT is valid and reliable, and has known minimal detectable changes. It has been validated in French and Dutch.; This is an inclusion questionnaire.
Ankle-specific Fear-Avoidance Beliefs Questionnaire	Baseline	This questionnaire is an adapted version of the original FABQ designed to assess kinesiophobia in people with low-back pain. The term "back" was changed to "ankle" and item 8 of the original FABQ was deleted. It contains two subscales: Physical Activity and Work.; Higher scores indicate more kinesiophobia. Scores ranging from 0 to 90.; The ankle-specific FABQ has shown acceptable internal consistency, and its use is encouraged in people with a history of ankle sprain, with known minimal detectable change. The FABQ questionnaire was validated in French, and a non-validated Dutch version was published.
Foot muscle strength	Baseline	Unit of measurement: Newton; Method: Foot muscle strength will be evaluated using a hand-held dynamometer, with participants hook lying. The investigators will both report the strength of the big toe and the strength of the other toes (as a whole). This method showed good to excellent intra and inter-rater reliability.
Foot Posture Index	Baseline	No unit of measurement.; The Foot Posture Index 6-item is a valid measure of foot posture (pronation, neutral and supination). Its reliability is subject of debate, ranging from poor to excellent for inter-rater and from moderate to excellent for intra-rater. The participants will stand bilaterally in a static position during the assessment.
Modified Star Excursion Balance Test	Baseline	Unit of measurement: cm; The modified Star Excursion Balance Test assesses dynamic balance. In recent studies involving subjects with CAI, the mSEBT was preferred over the original eight-direction version because the former measures are the most often altered in this population and the remaining directions add thus little value.; The original SEBT is reliable, valid, reproducible, and responsive to change.; The modified SEBT requires the participant to reach the ground as far as possible with his leg in the anterior, postero-medial and postero-lateral directions. The procedure is repeated until three valid trials are measured in each direction for each leg.; A mean score will then be calculated for each direction as the mean of the three valid trials with one leg. Those values will first be normalized by the leg length and a composite score will then be calculated as the mean of the three directions reached with one leg.
Perceived foot fatigue	Immediately after the end of the intervention	NB: Same as above; No unit of measurement.; Participants will be asked to score their perceived foot fatigue every four minutes during the fatigue protocol.; This will be done based on a verbal scale from 0 (no perceived fatigue at all) to 10 (highest fatigue the participant could imagine).; The foot muscle fatigue protocol lasts 16 minutes. Time frame 16 minutes is thus equal to "immediately post-intervention".
Change from baseline in hallux flexion strength after the intervention	Change between baseline and immediately post-intervention	Unit of measurement: Newton; Method: Hallux flexion strength will be evaluated using a hand-held dynamometer, with participants hook lying.; The difference between before and after the intervention (fatigue protocol) will be reported.

Trial Locations

Locations (1)

UZ Leuven, Pellenberg; 🇧🇪 Lubbeek, Belgium