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临床试验/NCT07467382
NCT07467382招募中不适用

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

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Achilles Tendon Young's Modulus

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Post-stroke and post-spinal cord injury population:
  • 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.

研究组 & 干预措施

Equinus pattern

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

干预措施: 3D Gait Analysis (Diagnostic Test)

Equinus pattern

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

干预措施: Ultrasound (Diagnostic Test)

Healthy controls

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

干预措施: 3D Gait Analysis (Diagnostic Test)

Healthy controls

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

干预措施: Ultrasound (Diagnostic Test)

Healthy controls

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

干预措施: Dynamometry (Diagnostic Test)

Equinus pattern

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

干预措施: Dynamometry (Diagnostic Test)

Non-equinus pattern

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

干预措施: 3D Gait Analysis (Diagnostic Test)

Non-equinus pattern

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

干预措施: Ultrasound (Diagnostic Test)

Non-equinus pattern

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

干预措施: Dynamometry (Diagnostic Test)

结局指标

主要结局

Achilles Tendon Young's Modulus

时间窗: Day 1 (Baseline)

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

次要结局

  • Achilles Tendon and Gastrocnemius Medialis Length and Volume(Day 1 (Baseline))
  • Gastrocnemius Medialis Voluntary Activation(Day 1 (Baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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