Talocrural Joint Manipulation in Stroke

July 3, 2025 updated by: Omer Dursun, Bitlis Eren University

The Effect of Talocrural Joint Manipulation on Static Balance in Patients With Stroke

The primary aim of the study is to investigate the effect of talocrural joint manipulation on the static balance of patients with stroke. The secondary aim of this study is to investigate the effect of talocrural joint manipulation on the dorsiflexion range of motion of patients with stroke.

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 treatments.

Study Type

Interventional

Enrollment (Actual)

64

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
    • Merkez
      • Bolu, Merkez, Turkey, 14020
        • 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. Two months or longer elapsed since the stroke,
  • 2. A Mini-Mental State Examination score of 24 or higher,
  • 3. The ability to stand independently for 20 seconds or more,
  • 4. The ability to walk independently for 10 meters with the use of walking aids or orthoses if necessary,
  • 5. Being between 45 and 75 years of age,
  • 6. 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. History of vertigo,
  • 6. Alcohol consumption within the last 24 hours,
  • 7. Hemodynamic instability,
  • 8. Diagnosis of posterior circulation stroke involving the basilar artery and cerebellum,
  • 9. The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
  • 10. Having experienced an acute lower extremity injury in the last six weeks,
  • 11. 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
Each group will receive both placebo and real talocrural joint manipulations in a randomized cross-over design. There will be a minimum interval of 48 hours between the interventions. Data obtained after the real manipulation will be recorded as the placebo comparator group data.
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.
Other: Placebo Talocrural Joint Manipulation
This intervention is a classic method used to evaluate the effect of talocrural joint manipulation.
Active Comparator: Talocrural Joint Manipulation Group
Each group will receive both placebo and real talocrural joint manipulations in a randomized cross-over design. There will be a minimum interval of 48 hours between the interventions. Data obtained after the real manipulation will be recorded as the active comparison group data.
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.
Other: Placebo Talocrural Joint Manipulation
This intervention is a classic method used to evaluate the effect of talocrural joint manipulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Stability Index Measurement
Time Frame: Change from baseline overall stability immediately after intervention
Overall stability index, evaluated using the Biodex Balance System. Overall stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior and mediolateral axes by the device. A lower score indicates smaller deviation and better postural stability. The assessment was conducted on a stable platform with three 20-second repetitions interspersed with 10-second rest periods. Participants remained standing during the rest periods, and the device automatically computed the average of the three repetitions. As the general stability index value increases, overall stability decreases. No definable minimum or maximum theoretical value.
Change from baseline overall stability immediately after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mediolateral Stability Index Measurement
Time Frame: Change from baseline mediolateral stability immediately after intervention
Mediolateral stability index, evaluated using the Biodex Balance System. Mediolateral stability index scores were derived from calculations of deviations from the center of gravity in the mediolateral axis by the device. As the mediolateral index value increases, mediolateral stability decreases. No definable minimum or maximum theoretical value.
Change from baseline mediolateral stability immediately after intervention
Anteroposterior Stability Index Measurement
Time Frame: Change from baseline anteroposterior stability immediately after intervention
Anteroposterior stability index, evaluated using the Biodex Balance System. Anteroposterior stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior axis by the device. As the overall anteroposterior stability value increases, anteroposterior stability decreases. No definable minimum or maximum theoretical value.
Change from baseline anteroposterior stability immediately after intervention
Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions
Time Frame: Change from baseline ankle dorsiflexion range of motion immediately after intervention
The patient was asked to stand facing the wall and place their hands on the wall at shoulder width apart, with the affected foot positioned behind and the knee in full extension. Then, without lifting the back foot or compromising knee extension, the patient was instructed to reach forward as far as possible. Subsequently, the calcaneal tubercle was placed one centimeter above the floor, and the measurement was taken with a water level gauge attached to the phone. The same measurement was repeated with the knee in flexion (20 degrees or more).
Change from baseline ankle dorsiflexion range of motion immediately after 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, Mr., 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)

August 2, 2024

Primary Completion (Actual)

November 27, 2024

Study Completion (Actual)

November 27, 2024

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEUFTR-5

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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