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临床试验/NCT07314918
NCT07314918已完成不适用

Structural Remodeling of the Tibialis Anterior Muscle in Subacute and Chronic Stroke: A Clinical Correlation Study

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Pennation Angle

研究概览

简要总结

This study aims to investigate the structural architectural changes of the Tibialis Anterior muscle in patients with subacute and chronic stroke using ultrasonography. The study will compare the morphological parameters (pennation angle, fascicle length, and muscle thickness) of the paretic side with the non-paretic side and analyze the relationship between these structural changes and the patients' clinical and demographic data.

详细描述

Stroke is a serious neurological disease characterized by high mortality, morbidity, and disability rates. Post-stroke motor and sensory impairments significantly limit patients' independence. A common impairment is hemiparesis, specifically weakness in the paretic leg leading to reduced dorsiflexion range of motion (foot drop). It remains unclear whether this weakness stems solely from neurological impairment or also involves changes in muscle architecture. Muscle fascicle length and pennation angle are critical architectural parameters influencing force production capacity.

研究设计

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

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients aged 40-80 years.
  • History of ischemic or hemorrhagic Cerebrovascular Accident (CVA).
  • Being in the subacute or chronic phase post-stroke.
  • Absence of communication deficits; ability to follow verbal commands.
  • Voluntary agreement to participate and provision of written informed consent.
  • Ability to ambulate without physical assistance from another person (use of assistive devices such as leg orthoses or tripods is permitted).

排除标准

  • Presence of other comorbidities affecting gait (e.g., Parkinson's disease, hip surgery, etc.).
  • History of dyspnea (shortness of breath) during activities of daily living within the last 6 months.
  • Presence of bone or joint-related pain or pathology in the spine or hips.
  • Presence of psychiatric or cognitive disorders (e.g., learning disabilities, mental disorders, autism, etc.).
  • Decompensated cardiac, renal, or hepatic failure.
  • Presence of malignancy.

研究组 & 干预措施

Subacute Stroke Patients

This group consists of patients in the subacute phase post-stroke (1 week to 6 months) who are receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital. Ultrasonographic assessment will be performed to determine the structural characteristics of the Tibialis anterior muscle. Measurements will be taken from the mid-belly region where muscle thickness is maximal. The patient will be in a supine position at rest, with the ankle in a neutral position on a stable surface. Pennation angle, muscle fascicle length, and muscle thickness will be measured. Measurements will be repeated three times, and the arithmetic mean of these three measurements will be calculated.

Chronic Stroke Patients

This group consists of patients in the chronic phase post-stroke ( > 6 months) who are receiving inpatient treatment at the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital.

Ultrasonographic assessment will be performed to determine the structural characteristics of the Tibialis anterior muscle. Measurements will be taken from the mid-belly region where muscle thickness is maximal. The patient will be in a supine position at rest, with the ankle in a neutral position on a stable surface. Pennation angle, muscle fascicle length, and muscle thickness will be measured. Measurements will be repeated three times, and the arithmetic mean of these three measurements will be calculated.

结局指标

主要结局

Pennation Angle

时间窗: at baseline assessment

The Pennation Angle is the angle formed between muscle fascicles and the deep aponeurosis, serving as a critical determinant of muscle force-generating capacity. Measured via longitudinal ultrasonography on the Tibialis Anterior, this parameter quantifies structural remodeling. In stroke survivors, alterations in this angle reflect muscle atrophy and directly impact functional recovery and gait potential.

Muscle Thickness

时间窗: at baseline assessment

Muscle Thickness is defined as the perpendicular distance between the superficial and deep aponeuroses at the widest point of the muscle belly. Measured via ultrasonography on the Tibialis Anterior, it serves as a direct indicator of muscle volume. In stroke survivors, reduced thickness quantifies the extent of muscle atrophy, providing insight into the loss of contractile mass and associated weakness.

Muscle Fascicle Length

时间窗: at baseline assessment

Muscle Fascicle Length is defined as the linear distance between the superficial and deep aponeuroses along the muscle fiber path. Assessed via ultrasonography in the Tibialis Anterior, this parameter is a key determinant of muscle shortening velocity and excursion range. In post-stroke patients, shortened fascicles often indicate structural adaptations related to spasticity and reduced functional mobility.

次要结局

  • The Brunnstrom Recovery Stage(at baseline assessment)
  • The Functional Ambulation Scale (FAS)(at baseline assessment)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eser Kalaoglu

Principal Investigator

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

研究点 (1)

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