Talocrural Manipulation and Ankle Muscle Architecture

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

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.

Inclusion Criteria:

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

Exclusion Criteria:

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