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Completed

NCT Number: NCT07264946

Talocrural Manipulation and Ankle Muscle Architecture

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Merkez, 14280, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Six months or longer elapsed since the stroke,
  • A Mini-Mental State Examination score of 24 or higher,
  • Being between 45 and 75 years of age,
  • Having a Brunnstrom stage of 4 or above

Exclusion criteria

  • The presence of severe osteoarthritis in the lower extremity,
  • The presence of cancer or diabetic neuropathy,
  • The presence of vestibular disorder,
  • The presence of lower extremity ulceration or amputation,
  • Hemodynamic instability,
  • The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
  • Having experienced an acute lower extremity injury in the last six weeks,
  • History of lower extremity surgery

Treatment and study plan

Placebo Talocrural Joint Manipulation

Other

This intervention is a classic method used to evaluate the effect of talocrural joint manipulation.

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.

Primary outcomes

  1. Ankle Muscle Architecture

    Time frame: Change from baseline ankle muscle architecture immediately after the intervention

    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.

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Registry information

Official study title

The Effect of Talocrural Joint Manipulation on Ankle Muscle Architecture: A Randomized Crossover Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2025
Registry last updated
Apr 3, 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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