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

Primary Purpose

Chronic Ankle Instability, Lateral Ankle Sprain

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Intrinsic foot muscle fatigue
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Ankle Instability focused on measuring Biomechanical phenomena, Kinetics, Kinematics, Intrinsic foot muscles, CAI, Plantar pressures, Ultrasound

Eligibility Criteria

18 Years - 44 Years (Adult)MaleAccepts Healthy Volunteers

Three groups of participants : Chronic ankle instability, lateral ankle sprain copers and healthy controls. INCLUSION CRITERIA: 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 : The same inclusion criteria as the LAS coper group, with the exception reported in the exclusion criteria. EXCLUSION CRITERIA: 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.

Sites / Locations

  • UZ Leuven, PellenbergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intrinsic foot muscle fatigue

No intrinsic foot muscle fatigue

Arm Description

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).

No fatigue of the intrinsic foot muscles.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Cumberland Ankle Instability Tool
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.
Foot and Ankle Activity Measure
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
Ankle-specific Fear-Avoidance Beliefs Questionnaire
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
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.
Change from baseline in hallux flexion strength after the 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.
Foot Posture Index
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.
Navicular drop
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
Modified Star Excursion Balance Test
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
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".
Perceived foot fatigue
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".
Perceived foot fatigue
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".
Perceived foot fatigue
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".
Electrostimulation current intensity
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".
Electrostimulation current intensity
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".
Electrostimulation current intensity
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".
Electrostimulation current intensity
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".

Full Information

First Posted
January 23, 2023
Last Updated
April 3, 2023
Sponsor
Université Catholique de Louvain
Collaborators
UZ Leuven, campus Pellenberg (Belgium)
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1. Study Identification

Unique Protocol Identification Number
NCT05815576
Brief Title
Biomechanics and Intrinsic Foot Muscle Roles in Subjects With Chronic Ankle Instability
Official Title
Lower Limb (Patho-)Mechanical Joint Contact Forces and Intrinsic Foot Muscle Properties in Subjects With Lateral Ankle Sprain and Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
Collaborators
UZ Leuven, campus Pellenberg (Belgium)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ankle Instability, Lateral Ankle Sprain
Keywords
Biomechanical phenomena, Kinetics, Kinematics, Intrinsic foot muscles, CAI, Plantar pressures, Ultrasound

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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,
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrinsic foot muscle fatigue
Arm Type
Experimental
Arm Description
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).
Arm Title
No intrinsic foot muscle fatigue
Arm Type
No Intervention
Arm Description
No fatigue of the intrinsic foot muscles.
Intervention Type
Behavioral
Intervention Name(s)
Intrinsic foot muscle fatigue
Intervention Description
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).
Primary Outcome Measure Information:
Title
Lower limb joint angles
Description
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.
Time Frame
Baseline
Title
Lower limb joint angles
Description
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.
Time Frame
5 minutes after the end of the intervention
Title
Lower limb joint angular velocities
Description
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.
Time Frame
Baseline
Title
Lower limb joint angular velocities
Description
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.
Time Frame
5 minutes after the end of the intervention
Title
Joint moments
Description
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.
Time Frame
Baseline
Title
Joint moments
Description
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.
Time Frame
5 minutes after the end of the intervention
Title
Joint powers
Description
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.
Time Frame
Baseline
Title
Joint powers
Description
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.
Time Frame
5 minutes after the end of the intervention
Title
Intrinsic foot muscle thickness
Description
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.
Time Frame
Baseline
Title
Intrinsic foot muscle area
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Cumberland Ankle Instability Tool
Description
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.
Time Frame
Baseline
Title
Foot and Ankle Activity Measure
Description
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
Time Frame
Baseline
Title
Ankle-specific Fear-Avoidance Beliefs Questionnaire
Description
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.
Time Frame
Baseline
Title
Foot muscle strength
Description
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.
Time Frame
Baseline
Title
Change from baseline in hallux flexion strength after the intervention
Description
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.
Time Frame
Change between baseline and immediately post-intervention
Title
Foot Posture Index
Description
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.
Time Frame
Baseline
Title
Navicular drop
Description
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
Time Frame
Baseline
Title
Modified Star Excursion Balance Test
Description
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.
Time Frame
Baseline
Title
Perceived foot fatigue
Description
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".
Time Frame
4 minutes after the beginning of the intervention
Title
Perceived foot fatigue
Description
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".
Time Frame
8 minutes after the beginning of the intervention
Title
Perceived foot fatigue
Description
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".
Time Frame
12 minutes after the beginning of the intervention
Title
Perceived foot fatigue
Description
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".
Time Frame
Immediately after the end of the intervention
Title
Electrostimulation current intensity
Description
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".
Time Frame
4 minutes after the beginning of the intervention
Title
Electrostimulation current intensity
Description
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".
Time Frame
8 minutes after the beginning of the intervention
Title
Electrostimulation current intensity
Description
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".
Time Frame
12 minutes after the beginning of the intervention
Title
Electrostimulation current intensity
Description
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".
Time Frame
Immediately after the end of the intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Three groups of participants : Chronic ankle instability, lateral ankle sprain copers and healthy controls. INCLUSION CRITERIA: 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 : The same inclusion criteria as the LAS coper group, with the exception reported in the exclusion criteria. EXCLUSION CRITERIA: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Louis Peters-Dickie
Phone
+32471687257
Email
jean-louis.peters@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Deschamps
Organizational Affiliation
Musculoskeletal Rehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Detrembleur
Organizational Affiliation
Neuro Musculo Skeletal Lab (NMSK), IREC, SSS, UCLouvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven, Pellenberg
City
Lubbeek
ZIP/Postal Code
B-3212
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Peters-Dickie
Phone
+32471687257
Email
jean-louis.peters@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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