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临床试验/NCT06474117
NCT06474117已完成不适用

Muscle-tendon Interaction in the Spastic Sural Triceps During Gait

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Length of the Achilles Tendon (AT), Muscle Fibers of the Gastrocnemius Medialis (GM), and the Muscle GM During the Single Support Phase of Walking

研究概览

简要总结

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.

详细描述

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.

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

  • 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

排除标准

  • 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

研究组 & 干预措施

Post-Stroke Patients

Patients will undergo gait analysis coupled with ultrasound to measure the lengths of the Achilles tendon and gastrocnemius medialis muscle. They will also have their force/length profile of the GM measured on an isokinetic dynamometer with simultaneous ultrasound

干预措施: Gait analysis coupled with ultrasound (Other)

Post-Stroke Patients

Patients will undergo gait analysis coupled with ultrasound to measure the lengths of the Achilles tendon and gastrocnemius medialis muscle. They will also have their force/length profile of the GM measured on an isokinetic dynamometer with simultaneous ultrasound

干预措施: Isokinetic dynamometer with simultaneous ultrasound (Other)

Post-Spinal Cord Injury Patients

Similar to the post-stroke group, these patients will undergo gait analysis coupled with ultrasound to measure the lengths of the Achilles tendon and gastrocnemius medialis muscle. The force/length profile of the GM will also be measured on an isokinetic dynamometer with simultaneous ultrasound.

干预措施: Gait analysis coupled with ultrasound (Other)

Post-Spinal Cord Injury Patients

Similar to the post-stroke group, these patients will undergo gait analysis coupled with ultrasound to measure the lengths of the Achilles tendon and gastrocnemius medialis muscle. The force/length profile of the GM will also be measured on an isokinetic dynamometer with simultaneous ultrasound.

干预措施: Isokinetic dynamometer with simultaneous ultrasound (Other)

Healthy controls

The healthy control group will undergo the same gait analysis and ultrasound measurements as the patient groups. Their force/length profile of the GM will also be measured on an isokinetic dynamometer with simultaneous ultrasound for comparison with the post-stroke and post-spinal cord injury groups.

干预措施: Gait analysis coupled with ultrasound (Other)

Healthy controls

The healthy control group will undergo the same gait analysis and ultrasound measurements as the patient groups. Their force/length profile of the GM will also be measured on an isokinetic dynamometer with simultaneous ultrasound for comparison with the post-stroke and post-spinal cord injury groups.

干预措施: Isokinetic dynamometer with simultaneous ultrasound (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Positioning of the Muscle Fibers on the Force-Length Curve During Different Phases of Walking(1 Day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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