NCT07467382

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
18mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

Achilles tendonGait analysisUltrasoundMuscle-tendon interaction

Outcome Measures

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.

    Day 1 (Baseline)

Secondary Outcomes (2)

  • Achilles Tendon and Gastrocnemius Medialis Length and Volume

    Day 1 (Baseline)

  • Gastrocnemius Medialis Voluntary Activation

    Day 1 (Baseline)

Study Arms (3)

Equinus pattern

Patients with stroke or incomplete spinal cord injury exhibiting an equinus gait pattern (excessive plantar flexion in terminal stance).

Diagnostic Test: 3D Gait AnalysisDiagnostic Test: UltrasoundDiagnostic Test: Dynamometry

Non-equinus pattern

Patients with stroke or incomplete spinal cord injury exhibiting a non-equinus gait.

Diagnostic Test: 3D Gait AnalysisDiagnostic Test: UltrasoundDiagnostic Test: Dynamometry

Healthy controls

Age, gender, height, and weight-matched individuals without neurological pathology.

Diagnostic Test: 3D Gait AnalysisDiagnostic Test: UltrasoundDiagnostic Test: Dynamometry

Interventions

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.

Equinus patternHealthy controlsNon-equinus pattern
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.

Equinus patternHealthy controlsNon-equinus pattern
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.

Equinus patternHealthy controlsNon-equinus pattern

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Study population:
  • 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
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeSpinal Cord Injuries

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Sponsor department

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03