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Completed

NCT Number: NCT06474117

Muscle-tendon Interaction in the Spastic Sural Triceps During Gait

This project aims to study the mechanical behavior of the muscle-tendon unit (MTU) of the gastrocnemius medialis (GM) and the Achilles tendon (AT) in post-stroke and spinal cord injured (SCI) patients compared to a healthy population, focusing on the variations in muscle and tendon length during the stance phase of the gait cycle. The primary objective is to assess the respective contributions of the GM and AT lengthening in the MTU during walking. Inclusion criteria include adult post-stroke and post-SCI patients with voluntary motor function and some walking capacity. Methods include ultrasound measurements and 3D gait analysis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, Loire Atlantique, 44093, France

About this study

Primary Objective: Evaluate the respective contributions of the gastrocnemius medialis (GM) muscle and the Achilles tendon (AT) within the muscle-tendon unit (MTU) during the single support phase of walking in post-stroke patients compared to healthy subjects.

Study Description: Strokes often lead to spastic paresis, degrading patients' walking performance. Instrumented gait analysis allows for the evaluation of these performances to propose adapted therapeutic strategies. This project will compare muscle and tendon behavior during walking between healthy individuals and post-stroke patients.

Methodology:

  • Participants: Adult post-stroke patients or incomplete SCI patients with voluntary motor function on the triceps surae and walking capacity. Control group composed of healthy adults.
  • Procedures:
  • Measure the force/length profile of the GM on an isokinetic dynamometer with simultaneous ultrasound.
  • Conduct gait analysis coupled with ultrasound to measure the lengths of the AT and GM.
  • Compare muscle and tendon length data during the stance phase of the gait cycle between the two groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Post-Stroke Population:

  • Adult male or female
  • Patient who had a stroke more than 7 days ago
  • Patient hospitalized (in conventional hospitalization or day hospital) in the university neurological rehabilitation department of CHU de Nantes
  • Patient with voluntary motor function graded between 2 and 4 on the MRC (Medical Research Council) scale at the GM level
  • Patient classified between 3 and 8 on the New Functional Ambulation Classification

Post-Spinal Cord Injury Population:

  • Adult male or female
  • Patient with an incomplete spinal cord injury classified as ASIA AIS C or D from level C2 to L5
  • Patient hospitalized (in conventional hospitalization or day hospital) in the neurological rehabilitation department of CHU de Nantes
  • Patient with voluntary motor function graded between 2 and 4 on the MRC (Medical Research Council) scale at the GM level
  • Patient classified between 3 and 8 on the New Functional Ambulation Classification

Healthy Population:

  • Adult male or female without any neurological disorders

Exclusion criteria

Post-Stroke and Post-Spinal Cord Injury Population:

  • Minor patient
  • History of calf surgery, surgery to reduce triceps surae spasticity, or intramuscular injection (e.g., botulinum toxin) in the plantar flexors within the last 6 months
  • Patient with a progressive condition contraindicating physical exertion (e.g., syrinx, cardiovascular instability)
  • Peripheral pathology of the considered lower limb

Healthy Population:

  • History of calf surgery
  • History of muscle injury, fracture, or sprain of the lower limb within the last 3 months
  • History of neurological disorders

Treatment and study plan

Gait analysis coupled with ultrasound

Other

Measure the lengths of the Achilles tendon and gastrocnemius medialis muscle

Isokinetic dynamometer with simultaneous ultrasound

Other

Measure the force/length profile of the gastrocnemius medialis muscle

Primary outcomes

  1. Length of the Achilles Tendon (AT), Muscle Fibers of the Gastrocnemius Medialis (GM), and the Muscle GM During the Single Support Phase of Walking

    Time frame: 1 Day

    This measure involves the use of ultrasound to assess the lengths of the Achilles tendon, muscle fibers of the gastrocnemius medialis, and the entire muscle GM during the single support phase of the gait cycle in post-stroke and SCI patients compared to healthy controls. The primary goal is to determine the contributions of the muscle and tendon to the overall muscle-tendon unit during walking.

Secondary outcomes

  1. Positioning of the Muscle Fibers on the Force-Length Curve During Different Phases of Walking

    Time frame: 1 Day

    This outcome measure evaluates the positioning of the muscle fibers of the gastrocnemius medialis on the force-length curve during various phases of the gait cycle, including the single support phase and the double support phases (reception and propulsion). The measurements will be compared between post-stroke, SCI patients and healthy controls. The assessment will involve ultrasound measurements and isokinetic dynamometry to determine the force-length relationship.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Laboratoire Motricité, Interactions, Performance (MIP)
  • Société Française de Physiothérapie (SFP).

Registry information

Acronym: GEcho

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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