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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-A00526-45 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Laboratoire Motricité, Interactions, Performance (MIP) | UNKNOWN |
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The purpose of this study is to evaluate the mechanical properties of the Achilles tendon (stiffness, length, volume) and the force production capacities of the gastrocnemius medialis muscle in patients with spastic paresis (post-stroke or incomplete spinal cord injury) compared to healthy subjects, during gait.
Spastic paresis alters the physiological muscle-tendon interaction during gait. Previous observations suggest that specific gait deviations, such as equinus and non-equinus patterns, are primarily driven by adaptations in the Achilles tendon behavior rather than the muscle belly structure. This observational, prospective study aims to characterize the determinants of these gait patterns by specifically investigating the mechanical properties of the Achilles tendon (stiffness, length, volume) relative to the force production capacities of the gastrocnemius medialis (GM) muscle (voluntary activation, volume).
A total of 60 participants will be recruited: 20 patients with post-stroke hemiparesis, 20 patients with incomplete spinal cord injury, and 20 age-, gender-, and morphologically matched healthy controls. Neurological participants will be stratified into "equinus" or "non-equinus" cohorts based on their ankle kinematics during the terminal stance phase of gait.
The study protocol consists of a single evaluation session per participant, comprising three main assessments:
Force and Tendon Mechanics Evaluation: Conducted on an isokinetic dynamometer. Passive mobilization and isometric plantar flexion contractions (submaximal and maximal) will be performed. The twitch interpolation technique, using superimposed electrical stimulation of the tibial nerve, will be applied to assess the voluntary activation level of the GM. Concurrently, an ultrasound probe placed on the GM myotendinous junction will track tissue displacement to calculate Achilles tendon stiffness.
Synchronized 3D Gait Analysis: Participants will perform several walking trials in a motion analysis laboratory. Three-dimensional kinematics (reflective markers), muscle activity (surface electromyography on lower limb muscles), and real-time muscle-tendon behavior (ultrasound imaging of the calf) will be recorded synchronously to evaluate the in vivo behavior of the muscle-tendon unit.
3D Ultrasound Acquisition: A free-hand 3D ultrasound sweep of the GM muscle and Achilles tendon will be performed with the participant in a prone position to reconstruct and measure tissue volumes and lengths.
The primary outcome is the Young's modulus of the Achilles tendon. Secondary outcomes include structural parameters (length and volume) and maximal voluntary activation. Statistical analyses will compare these parameters across the equinus, non-equinus, and healthy control groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Equinus pattern | Patients with stroke or incomplete spinal cord injury exhibiting an equinus gait pattern (excessive plantar flexion in terminal stance). |
| |
| Non-equinus pattern | Patients with stroke or incomplete spinal cord injury exhibiting a non-equinus gait. |
| |
| Healthy controls | Age, gender, height, and weight-matched individuals without neurological pathology. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Gait Analysis | Diagnostic Test | Evaluation includes maximal and sub-maximal isometric plantar flexion on a dynamometer with electrical stimulation, 3D quantified gait analysis synchronized with surface electromyography and ultrasound, and 3D ultrasound volume acquisition. |
| Measure | Description | Time Frame |
|---|---|---|
| Achilles Tendon Young's Modulus | Young's modulus of the Achilles tendon (in kPa) measured at 3% tendon strain using ultrasound and dynamometry. | Day 1 (Baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Achilles Tendon and Gastrocnemius Medialis Length and Volume | Length and volume reconstructed via 3D ultrasound using 3DSlicer software. | Day 1 (Baseline) |
| Gastrocnemius Medialis Voluntary Activation |
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Inclusion Criteria:
Study population:
• Cognitive abilities compatible with the experiment: no language or judgement disorders preventing understanding of the research or expression of consent. An aphasia severity score greater than or equal to 3 on the Boston Diagnostic Aphasia Examination (BDAE) scale will be required for inclusion.
Post-stroke population:
Post-spinal cord injury population:
Healthy population:
• Adult men or women with no nervous system disorders.
Exclusion Criteria:
Post-stroke and post-spinal cord injury population:
Healthy population:
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A maximum of 60 subjects will be included. Twenty will be post-stroke patients with hemiparesis, 20 will be post-incomplete spinal cord injury patients, and 20 will be healthy subjects.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Lecharte | Contact | 02 44 76 89 89 | +33 | thomas.lecharte@chu-nantes.fr |
| Sponsor department | Contact | bp-prom-regl@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | France |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Ultrasound | Diagnostic Test | Evaluation includes maximal and sub-maximal isometric plantar flexion on a dynamometer with electrical stimulation, 3D quantified gait analysis synchronized with surface electromyography and ultrasound, and 3D ultrasound volume acquisition. |
|
| Dynamometry | Diagnostic Test | Evaluation includes maximal and sub-maximal isometric plantar flexion on a dynamometer with electrical stimulation, 3D quantified gait analysis synchronized with surface electromyography and ultrasound, and 3D ultrasound volume acquisition. |
|
Maximal voluntary activation measured using the twitch interpolation technique.
| Day 1 (Baseline) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |