- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467382
GOAT (Gait Observation of Achilles Tendon) (GOAT)
Characterization of Mechanical Properties of Achilles Tendon During Gait in Spastic Paresis Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sponsor department
- Email: bp-prom-regl@chu-nantes.fr
Study Contact Backup
- Name: Thomas Lecharte
- Phone Number: +33 02 44 76 89 89
- Email: thomas.lecharte@chu-nantes.fr
Study Locations
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Nantes, France
- CHU de Nantes
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Principal Investigator:
- Thomas LECHARTE
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Contact:
- Thomas LECHARTE
- Phone Number: +33 0244768989
- Email: thomas.lecharte@chu-nantes.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- Adult male or female
- Patient who has had a stroke > 7 days ago
- Patient hospitalised (in conventional hospitalisation or day hospital) in the neurological physical and medical rehabilitation department of Nantes University Hospital
- Patients with voluntary motor function rated between 2 and 4 on the MRC (Medical Research Council) scale at the GM level
- Patients classified as 3 to 8 on the New Functional Ambulation Classification
- Indication to perform a quantified gait analysis as part of clinical management
Post-spinal cord injury population:
- Adult men or women
- Patients with incomplete spinal cord injury graded ASIA AIS C or D from C2 to L5
- Patients hospitalised (in conventional hospitalisation or day hospital) in the neurological physical and occupational therapy department of Nantes University Hospital
- Patients with voluntary motor function rated between 2 and 4 on the MRC (Medical Research Council) scale at GM level
- Patients rated 13-20 on the WISCI-II scale
- Indication for a quantified gait analysis as part of clinical care
Healthy population:
• Adult men or women with no nervous system disorders.
Exclusion Criteria:
Post-stroke and post-spinal cord injury population:
- Minors;
- History of calf surgery, surgery to reduce triceps surae spasticity, or intramuscular injection (e.g. botulinum toxin) in the plantar flexors < 6 months;
- Patients with a progressive condition that contraindicates exertion (syrinx, cardiovascular instability);
- Peripheral pathology of the lower limb in question.
Healthy population:
- History of calf surgery;
- History of muscle injury, fracture or sprain of the lower limb < 3 months;
- History of neurological condition.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Equinus pattern
Patients with stroke or incomplete spinal cord injury exhibiting an equinus gait pattern (excessive plantar flexion in terminal stance).
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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.
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.
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.
|
|
Non-equinus pattern
Patients with stroke or incomplete spinal cord injury exhibiting a non-equinus gait.
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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.
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.
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.
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Healthy controls
Age, gender, height, and weight-matched individuals without neurological pathology.
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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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Achilles Tendon Young's Modulus
Time Frame: Day 1 (Baseline)
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Young's modulus of the Achilles tendon (in kPa) measured at 3% tendon strain using ultrasound and dynamometry.
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Day 1 (Baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Achilles Tendon and Gastrocnemius Medialis Length and Volume
Time Frame: Day 1 (Baseline)
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Length and volume reconstructed via 3D ultrasound using 3DSlicer software.
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Day 1 (Baseline)
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Gastrocnemius Medialis Voluntary Activation
Time Frame: Day 1 (Baseline)
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Maximal voluntary activation measured using the twitch interpolation technique.
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Day 1 (Baseline)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Stroke
- Spinal Cord Injuries
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Ultrasonography
Other Study ID Numbers
- RC26_0051
- 2026-A00526-45 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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