Health TrialsbyHealthPanel

GOAT (Gait Observation of Achilles Tendon)

ConditionsSpastic ParesisStrokeSpinal Cord Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Equinus pattern3 interventions
Group B: Non-equinus pattern3 interventions
Group C: Healthy controls3 interventions

Trial outcomes

Primary outcomes

1

Achilles Tendon Young's Modulus

Young's modulus of the Achilles tendon (in kPa) measured at 3% tendon strain using ultrasound and dynamometry.

Time frame
Day 1 (Baseline)

Secondary outcomes

1

Achilles Tendon and Gastrocnemius Medialis Length and Volume

Length and volume reconstructed via 3D ultrasound using 3DSlicer software.

Time frame
Day 1 (Baseline)
2

Gastrocnemius Medialis Voluntary Activation

Maximal voluntary activation measured using the twitch interpolation technique.

Time frame
Day 1 (Baseline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nantes University Hospital

Lead sponsor

Laboratoire Motricité, Interactions, Performance (MIP)

Collaborator

Source ClinicalTrials.gov
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