Talocrural Joint Manipulation in Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Placebo Talocrural Joint Manipulation; Other: Talocrural Joint Manipulation

• Registration Number: NCT06523010
• Lead Sponsor: Bitlis Eren University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Status Verified: 2024-08
• Study Start: 2024-08-02
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2024-12-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Talocrural Joint Manipulation Group	Placebo Talocrural Joint Manipulation	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.
Talocrural Joint Manipulation Group	Talocrural Joint Manipulation	In this group, talocrural joint manipulation will be applied. After positioning the patient, high velocity low amplitude traction will be applied.

Primary Outcome Measures

Name	Time	Method
Overall Stability Index Measurement	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.

Secondary Outcome Measures

Name	Time	Method
Ankle Dorsiflexion Range of Motion Measurement	Change from baseline ankle dorsiflexion range of motion immediately after intervention	The patient will be 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 will be instructed to reach forward as far as possible. Subsequently, the calcaneal tubercle will be placed one centimeter above the floor, and the measurement will be taken with a water level gauge attached to the phone. The same measurement will be repeated with the knee in flexion (20 degrees or more).
Anteroposterior Stability Index Measurement	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.
Mediolateral Stability Index Measurement	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.

Trial Locations

Locations (1)

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi; 🇹🇷 Bolu, Merkez, Turkey