Spastic ParesisGOATNCT07467382
GOAT (Gait Observation of Achilles Tendon)
An observational study of Spastic Paresis and Stroke, run by Nantes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spastic Paresis, Stroke, Spinal Cord Injury
- What is being tested?
- 3D Gait Analysis, Ultrasound and Dynamometry
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
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- History of calf surgery;
- History of muscle injury, fracture or sprain of the lower limb < 3 months;
- History of neurological condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sponsor department contact
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes
Thomas LECHARTE, 0244768989 ext. +33, thomas.lecharte@chu-nantes.fr
Thomas LECHARTE
About this study
Official title: Characterization of Mechanical Properties of Achilles Tendon During Gait in Spastic Paresis Syndrome
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.
Read the 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.
- Conditions
- Spastic Paresis, Stroke, Spinal Cord Injury
- Being tested
- 3D Gait Analysis, Ultrasound, Dynamometry
- Keywords
- Achilles tendon, Gait analysis, Ultrasound, Muscle-tendon interaction
- Medical subject headings
- Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Gait AnalysisDiagnostic 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.
UltrasoundDiagnostic 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.
DynamometryDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Equinus pattern | Patients with stroke or incomplete spinal cord injury exhibiting an equinus gait pattern (excessive plantar flexion in terminal stance). Receives: Diagnostic Test: 3D Gait Analysis; Diagnostic Test: Ultrasound; Diagnostic Test: Dynamometry | |
| Non-equinus pattern | Patients with stroke or incomplete spinal cord injury exhibiting a non-equinus gait. Receives: Diagnostic Test: 3D Gait Analysis; Diagnostic Test: Ultrasound; Diagnostic Test: Dynamometry | |
| Healthy controls | Age, gender, height, and weight-matched individuals without neurological pathology. Receives: Diagnostic Test: 3D Gait Analysis; Diagnostic Test: Ultrasound; Diagnostic Test: Dynamometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achilles Tendon Young's Modulus
Young's modulus of the Achilles tendon (in kPa) measured at 3% tendon strain using ultrasound and dynamometry.
Measured: Day 1 (Baseline)
Secondary outcomes (2)
Achilles Tendon and Gastrocnemius Medialis Length and Volume
Length and volume reconstructed via 3D ultrasound using 3DSlicer software.
Measured: Day 1 (Baseline)
Gastrocnemius Medialis Voluntary Activation
Maximal voluntary activation measured using the twitch interpolation technique.
Measured: Day 1 (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic ParesisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Motricité, Interactions, Performance (MIP)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467382
- Sponsor's protocol ID
- RC26_0051
- Other IDs
- 2026-A00526-45
- Acronym
- GOAT
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Mechanical Properties of Achilles Tendon During Gait in Spastic Paresis Syndrome
- ClinicalTrials.gov ID
- NCT07467382
- Acronym / sponsor ID
- GOAT / RC26_0051
- Conditions
- Spastic Paresis, Stroke, Spinal Cord Injury
- Keywords
- Achilles tendon, Gait analysis, Ultrasound, Muscle-tendon interaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Laboratoire Motricité, Interactions, Performance (MIP)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Mar 2026 (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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Equinus pattern | – | Diagnostic Test: 3D Gait Analysis, Diagnostic Test: Ultrasound, Diagnostic Test: DynamometryPatients with stroke or incomplete spinal cord injury exhibiting an equinus gait pattern (excessive plantar flexion in terminal stance). |
| Non-equinus pattern | – | Diagnostic Test: 3D Gait Analysis, Diagnostic Test: Ultrasound, Diagnostic Test: DynamometryPatients with stroke or incomplete spinal cord injury exhibiting a non-equinus gait. |
| Healthy controls | – | Diagnostic Test: 3D Gait Analysis, Diagnostic Test: Ultrasound, Diagnostic Test: DynamometryAge, gender, height, and weight-matched individuals without neurological pathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (18 listed)
- 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.
- 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
Key exclusion criteria (9 listed)
- 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.
- History of calf surgery;
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 |
|---|---|---|
| 3D Gait AnalysisEvaluation 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. | Diagnostic test | Equinus pattern, Healthy controls, Non-equinus pattern |
| UltrasoundEvaluation 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. | Diagnostic test | Equinus pattern, Healthy controls, Non-equinus pattern |
| DynamometryEvaluation 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. | Diagnostic test | Equinus pattern, Healthy controls, Non-equinus pattern |
Primary outcome
Achilles Tendon Young's Modulus
Time frame: Day 1 (Baseline)
Young's modulus of the Achilles tendon (in kPa) measured at 3% tendon strain using ultrasound and dynamometry.
2 secondary outcomes
Achilles Tendon and Gastrocnemius Medialis Length and Volume
Time frame: Day 1 (Baseline)
Gastrocnemius Medialis Voluntary Activation
Time frame: Day 1 (Baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sponsor department contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Paresis and Stroke, run by Nantes University Hospital at 1 site in France.
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 18 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Lecharte (02 44 76 89 89 ext. +33, thomas.lecharte@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achilles Tendon Young's Modulus (time frame: Day 1 (Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.