Menu
Not yet recruiting NCT07467382

GOAT (Gait Observation of Achilles Tendon)

Observational Spastic Paresis Stroke Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D Gait Analysis, Ultrasound, Dynamometry.
Who it may be relevant to
Registry conditions: Spastic Paresis, Stroke, Spinal Cord Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Characterization of Mechanical Properties of Achilles Tendon During Gait in Spastic Paresis Syndrome

Overview

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.

Interventions

  • Diagnostic test 3D Gait Analysis
    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.
  • Diagnostic test Ultrasound
    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.
  • Diagnostic test Dynamometry
    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.

Primary outcome measures

  • Achilles Tendon Young's Modulus [Time frame: Day 1 (Baseline)]
Secondary outcome measures (2)
  • Achilles Tendon and Gastrocnemius Medialis Length and Volume [Time frame: Day 1 (Baseline)]
  • Gastrocnemius Medialis Voluntary Activation [Time frame: Day 1 (Baseline)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

France · 1 center
  • CHU de Nantes — Nantes

Identifiers

NCT: NCT07467382 · RC26_0051 · 2026-A00526-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗