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NCT Number: NCT07314918

Structural Remodeling of Tibialis Anterior Muscle in Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Tibialis Anterior Architecture Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Pennation Angle

    Time frame: 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.

  2. Muscle Thickness

    Time frame: 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.

  3. Muscle Fascicle Length

    Time frame: 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.

Secondary outcomes

  1. The Brunnstrom Recovery Stage

    Time frame: at baseline assessment

    The Brunnstrom Recovery Stage is a standardized clinical tool used to evaluate motor recovery in stroke survivors. It classifies the progression of motor function into six sequential stages, ranging from flaccidity (Stage 1) to isolated, near-normal movement (Stage 6). In this study, it quantifies lower extremity motor impairment to correlate functional recovery status with the structural architectural changes observed in the Tibialis Anterior muscle.

  2. The Functional Ambulation Scale (FAS)

    Time frame: at baseline assessment

    The Functional Ambulation Scale (FAS) is a clinical instrument used to categorize gait ability based on the level of physical assistance required by the patient. Classifications range from 0 (non-functional) to 5 (independent). In this study, FAS is utilized to quantify walking dependence, facilitating the analysis of the relationship between functional mobility levels and the structural remodeling of the Tibialis Anterior muscle.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2026
Registry last updated
Jan 6, 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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