Structural Remodeling of Tibialis Anterior Muscle in Stroke

NCT ID: NCT07314918

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-12-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Tibialis Anterior Architecture

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eser Kalaoglu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eser Kalaoğlu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Locations

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Ramsay JW, Barrance PJ, Buchanan TS, Higginson JS. Paretic muscle atrophy and non-contractile tissue content in individual muscles of the post-stroke lower extremity. J Biomech. 2011 Nov 10;44(16):2741-6. doi: 10.1016/j.jbiomech.2011.09.001. Epub 2011 Sep 25.

Reference Type RESULT
PMID: 21945568 (View on PubMed)

Lieber RL, Friden J. Clinical significance of skeletal muscle architecture. Clin Orthop Relat Res. 2001 Feb;(383):140-51. doi: 10.1097/00003086-200102000-00016.

Reference Type RESULT
PMID: 11210948 (View on PubMed)

Kottink AI, Oostendorp LJ, Buurke JH, Nene AV, Hermens HJ, IJzerman MJ. The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review. Artif Organs. 2004 Jun;28(6):577-86. doi: 10.1111/j.1525-1594.2004.07310.x.

Reference Type RESULT
PMID: 15153151 (View on PubMed)

Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

Reference Type RESULT
PMID: 21571152 (View on PubMed)

Ramsay JW, Wessel MA, Buchanan TS, Higginson JS. Poststroke muscle architectural parameters of the tibialis anterior and the potential implications for rehabilitation of foot drop. Stroke Res Treat. 2014;2014:948475. doi: 10.1155/2014/948475. Epub 2014 Jul 16.

Reference Type RESULT
PMID: 25133011 (View on PubMed)

Other Identifiers

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IstPRMTRH-EK5

Identifier Type: -

Identifier Source: org_study_id

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