StrokeNCT07314918
Structural Remodeling of Tibialis Anterior Muscle in Stroke
An observational study of Stroke and Tibialis Anterior Architecture, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke, Tibialis Anterior Architecture
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 25 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, 34186
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Tibialis Anterior Architecture
- Keywords
- Ultrasonography, Stroke, Muscle Architecture, Pennation Angle, Fascicle Length, Muscle Thickness
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Pennation Angle
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.
Measured: at baseline assessment
Muscle Thickness
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.
Measured: at baseline assessment
Muscle Fascicle Length
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.
Measured: at baseline assessment
Secondary outcomes (2)
The Brunnstrom Recovery Stage
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.
Measured: at baseline assessment
The Functional Ambulation Scale (FAS)
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.
Measured: at baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 May 2025
- Primary completion1 Jul 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eser Kalaoglu, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Eser Kalaoğlu, M.D., Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314918
- Sponsor's protocol ID
- IstPRMTRH-EK5
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 21945568Lieber RL, Friden J. Clinical significance of skeletal muscle architecture. Clin Orthop Relat Res. 2001 Feb;(383):140-51. doi: 10.1097/00003086-200102000-00016.
PubMed 11210948Kottink 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.
PubMed 15153151Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
PubMed 21571152Ramsay 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.
PubMed 25133011
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural Remodeling of the Tibialis Anterior Muscle in Subacute and Chronic Stroke: A Clinical Correlation Study
- ClinicalTrials.gov ID
- NCT07314918
- Acronym / sponsor ID
- IstPRMTRH-EK5
- Conditions
- Stroke, Tibialis Anterior Architecture
- Keywords
- Ultrasonography, Stroke, Muscle Architecture, Pennation Angle, Fascicle Length, Muscle Thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
2 secondary outcomes
The Brunnstrom Recovery Stage
Time frame: at baseline assessment
The Functional Ambulation Scale (FAS)
Time frame: at baseline assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 21945568Ramsay 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.
- Results publication: PubMed 11210948Lieber RL, Friden J. Clinical significance of skeletal muscle architecture. Clin Orthop Relat Res. 2001 Feb;(383):140-51. doi: 10.1097/00003086-200102000-00016.
- Results publication: PubMed 15153151Kottink 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.
- Results publication: PubMed 21571152Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- Results publication: PubMed 25133011Ramsay 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eser Kalaoğlu, M.D. principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Tibialis Anterior Architecture, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pennation Angle (time frame: at baseline assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07314918, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.