Chronic Ankle InstabilityNCT05815576
Biomechanics and Intrinsic Foot Muscle Roles in Subjects With Chronic Ankle Instability
A study testing Intrinsic foot muscle fatigue in people with Chronic Ankle Instability and Lateral Ankle Sprain, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability, Lateral Ankle Sprain
- What is being tested?
- Intrinsic foot muscle fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Feb 2023to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lower Limb (Patho-)Mechanical Joint Contact Forces and Intrinsic Foot Muscle Properties in Subjects With Lateral Ankle Sprain and Chronic Ankle Instability
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
- Being tested
- Intrinsic foot muscle fatigue
- Keywords
- Biomechanical phenomena, Kinetics, Kinematics, Intrinsic foot muscles, CAI, Plantar pressures, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrinsic foot muscle fatigueBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Intrinsic foot muscle fatigue |
| No intrinsic foot muscle fatigue | No intervention | No fatigue of the intrinsic foot muscles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (16)
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.
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Change between baseline and immediately post-intervention
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.
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
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".
Measured: 4 minutes after the beginning of the 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".
Measured: 8 minutes after the beginning of the 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".
Measured: 12 minutes after the beginning of the 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".
Measured: Immediately after the end of the 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".
Measured: 4 minutes after the beginning of the 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".
Measured: 8 minutes after the beginning of the 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".
Measured: 12 minutes after the beginning of the 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".
Measured: Immediately after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start3 Feb 2023
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- UZ Leuven, campus Pellenberg (Belgium)
- Responsible party
- Sponsor
- Investigators
- Kevin Deschamps, Principal investigator, Musculoskeletal Rehabilitation Research Group, Department of Rehabilitation Sciences, KU LeuvenChristine Detrembleur, Principal investigator, Neuro Musculo Skeletal Lab (NMSK), IREC, SSS, UCLouvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815576
- Sponsor's protocol ID
- B3222022000964
- Other IDs
- S66498
- Status last verified
- Aug 2025
- First submitted
- 23 Jan 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peters-Dickie JL, Detrembleur C, Lobet S, Deschamps K. Side-Step Cutting Foot Biomechanics and Intrinsic Foot Muscle Sizes in People With Chronic Ankle Instability. J Foot Ankle Res. 2026 Dec;19(4):e70222. doi: 10.1002/jfa2.70222.
PubMed 42873647
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb (Patho-)Mechanical Joint Contact Forces and Intrinsic Foot Muscle Properties in Subjects With Lateral Ankle Sprain and Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05815576
- Acronym / sponsor ID
- B3222022000964
- Conditions
- Chronic Ankle Instability, Lateral Ankle Sprain
- Keywords
- Biomechanical phenomena, Kinetics, Kinematics, Intrinsic foot muscles, CAI, Plantar pressures, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- UZ Leuven, campus Pellenberg (Belgium)
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intrinsic foot muscle fatigue | Experimental | Behavioral: Intrinsic foot muscle fatigueThe 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 intrinsic foot muscle fatigue | No intervention | –No fatigue of the intrinsic foot muscles. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- For all three groups :
- Chronic ankle instability :
- Lateral ankle sprain copers :
- Healthy controls :
Key exclusion criteria (11 listed)
- For all three groups :
- For healthy controls : the healthy control subjects may not have suffered from an ankle sprain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrinsic foot muscle fatigueElectrostimulation 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). | Behavioural | Intrinsic foot muscle fatigue |
Primary outcome
Lower limb joint angles
Time frame: Baseline
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
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: Baseline
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
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 moments
Time frame: Baseline
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
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.
Joint powers
Time frame: Baseline
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
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 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.
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.
16 secondary outcomes
Cumberland Ankle Instability Tool
Time frame: Baseline
Foot and Ankle Activity Measure
Time frame: Baseline
Ankle-specific Fear-Avoidance Beliefs Questionnaire
Time frame: Baseline
Foot muscle strength
Time frame: Baseline
Change from baseline in hallux flexion strength after the intervention
Time frame: Change between baseline and immediately post-intervention
Foot Posture Index
Time frame: Baseline
Navicular drop
Time frame: Baseline
Modified Star Excursion Balance Test
Time frame: Baseline
Perceived foot fatigue
Time frame: 4 minutes after the beginning of the intervention
Perceived foot fatigue
Time frame: 8 minutes after the beginning of the intervention
Perceived foot fatigue
Time frame: 12 minutes after the beginning of the intervention
Perceived foot fatigue
Time frame: Immediately after the end of the intervention
Electrostimulation current intensity
Time frame: 4 minutes after the beginning of the intervention
Electrostimulation current intensity
Time frame: 8 minutes after the beginning of the intervention
Electrostimulation current intensity
Time frame: 12 minutes after the beginning of the intervention
Electrostimulation current intensity
Time frame: Immediately after the end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 42873647Peters-Dickie JL, Detrembleur C, Lobet S, Deschamps K. Side-Step Cutting Foot Biomechanics and Intrinsic Foot Muscle Sizes in People With Chronic Ankle Instability. J Foot Ankle Res. 2026 Dec;19(4):e70222. doi: 10.1002/jfa2.70222.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Deschamps principal investigator
Musculoskeletal Rehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven
Christine Detrembleur principal investigator
Neuro Musculo Skeletal Lab (NMSK), IREC, SSS, UCLouvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrinsic foot muscle fatigue in people with Chronic Ankle Instability and Lateral Ankle Sprain, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower limb joint angles (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05815576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.