Stroke
Conditions
Keywords
Muscle architecture, Ankle
Brief summary
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.
Detailed description
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.
Interventions
This intervention is a classic method used to evaluate the effect of talocrural joint manipulation.
This technique, aiming to increase ankle dorsiflexion and mechanoreceptor activation, is based on the application of high velocity low amplitude traction to the joint.
Sponsors
Bitlis Eren University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The evaluator and the researcher administering the intervention will be different. The interventions will be administered to participants randomly.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankle Muscle Architecture | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORömer dursun, Asst. Prof.
Bitlis Eren University
PRINCIPAL_INVESTIGATORburak mavuş, M.Sc.
Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
PRINCIPAL_INVESTIGATORyakup erden, M.D.
Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
PRINCIPAL_INVESTIGATORali gündüz, PT
Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
Outcome results
None listed