Structural Remodeling of Tibialis Anterior Muscle in Stroke

January 5, 2026 updated by: Eser Kalaoglu, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34186
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline assessment
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.
at baseline assessment
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.
at baseline assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline assessment
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.
at baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Principal Investigator: Eser Kalaoglu, M.D., Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

December 25, 2025

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPRMTRH-EK5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD), including all demographic, clinical, and primary/secondary outcome measures will be shared with qualified researchers. The sharing period will commence 6 months after article publication and conclude 1 year thereafter. Data access requests must be accompanied by a methodologically sound proposal and will be granted upon the corresponding author's approval and the execution of a Data Use Agreement (DUA) to strictly ensure confidentiality and adherence to ethical guidelines.

IPD Sharing Time Frame

Beginning 6 months and ending 1 year following article publication.

IPD Sharing Access Criteria

Qualified researchers who present a methodologically robust proposal aimed at fulfilling the objectives of the approved project.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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