Talocrural Manipulation and Ankle Muscle Architecture

March 29, 2026 updated by: Omer Dursun, Bitlis Eren University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Bolu, Merkez, Turkey (Türkiye), 14280
        • Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Talocrural Joint Manipulation Group
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.
Other: Placebo Talocrural Joint Manipulation
This intervention is a classic method used to evaluate the effect of talocrural joint manipulation.
Experimental: Talocrural Joint Manipulation Group
In this group, talocrural joint manipulation will be applied. After positioning the patient, high velocity low amplitude traction will be applied.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline ankle muscle architecture immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitlis Eren University

Investigators

  • Principal Investigator: ömer dursun, Asst. Prof., Bitlis Eren University
  • Principal Investigator: burak mavuş, M.Sc., Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
  • Principal Investigator: yakup erden, M.D., Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
  • Principal Investigator: ali gündüz, PT, Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2025

Primary Completion (Actual)

November 15, 2025

Study Completion (Actual)

November 15, 2025

Study Registration Dates

First Submitted

November 22, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEUFTR-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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