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The aim of this study is to investigate the effect of talocrural joint manipulation on the ankle muscle architecture in patients with stroke. This study was registered retrospectively due to the U.S. government shutdown (October 1 to November 12, 2025), which prevented timely registration despite prior intent to register prospectively.
The study, utilizing a randomized crossover design, is planned to be conducted on a minimum of 26 patients with stroke who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to receive both placebo talocrural joint manipulation and talocrural joint manipulation interventions. The study was originally intended to be registered prospectively. However, it was conducted during a period of administrative disruption related to the U.S. government shutdown (October 1 to November 12, 2025), which affected access to federal systems and delayed trial registration processes. As a result, registration could not be completed as planned, and the study was registered retrospectively (first submitted on November 22, 2025; first posted on December 4, 2025). The investigators confirm that the study protocol, including primary and secondary outcome measures, was finalized prior to the initiation of participant enrollment and remained unchanged throughout the study. This statement is provided to ensure transparency and to clarify that the delay in registration was due to circumstances beyond the investigators' control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Talocrural Joint Manipulation Group | Placebo Comparator | In this group, patients will receive placebo talocrural joint manipulation. The application will be similar to that in the experimental group, however, hands will be positioned to avoid creating traction or manipulation force, and this position will be maintained for 20 seconds. |
|
| Talocrural Joint Manipulation Group | Experimental | In this group, talocrural joint manipulation will be applied. After positioning the patient, high velocity low amplitude traction will be applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Talocrural Joint Manipulation | Other | This intervention is a classic method used to evaluate the effect of talocrural joint manipulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Muscle Architecture | The effect of talocrural joint manipulation on ankle muscle architecture will be evaluated using ultrasound imaging. The device will be used to analyze the pennation angle of the medial and lateral gastrocnemius muscles as well as the tibialis anterior muscle. | Change from baseline ankle muscle architecture immediately after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ömer dursun, Asst. Prof. | Bitlis Eren University | Principal Investigator |
| burak mavuÅŸ, M.Sc. | Bolu Abant Ä°zzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital | Principal Investigator |
| yakup erden, M.D. | Bolu Abant Ä°zzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital | Principal Investigator |
| ali gündüz, PT | Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi | Bolu | Merkez | 14280 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27231199 | Background | Vorkas PA, Shalhoub J, Lewis MR, Spagou K, Want EJ, Nicholson JK, Davies AH, Holmes E. Metabolic Phenotypes of Carotid Atherosclerotic Plaques Relate to Stroke Risk: An Exploratory Study. Eur J Vasc Endovasc Surg. 2016 Jul;52(1):5-10. doi: 10.1016/j.ejvs.2016.01.022. Epub 2016 May 23. | |
| 30482315 | Background |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The patients enrolled in the study will receive placebo talocrural joint traction and talocrural joint traction in a randomized sequence. The order of the interventions will be determined by flipping a coin.
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The evaluator and the researcher administering the intervention will be different. The interventions will be administered to participants randomly.
| Talocrural Joint Manipulation | Other | This technique, aiming to increase ankle dorsiflexion and mechanoreceptor activation, is based on the application of high velocity low amplitude traction to the joint. |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |