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NCT Number: NCT06523010

Talocrural Joint Manipulation in 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

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, 14020, 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 treatments.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Placebo Talocrural Joint Manipulation

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Jul 23, 2025

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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