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Clinical Trials/NCT06523010
NCT06523010
Completed
Not Applicable

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

Bitlis Eren University1 site in 1 country64 target enrollmentAugust 2, 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Bitlis Eren University
Enrollment
64
Locations
1
Primary Endpoint
Overall Stability Index Measurement
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2, 2024
End Date
November 27, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Bitlis Eren University
Responsible Party
Principal Investigator
Principal Investigator

Omer Dursun

Asst. Prof.

Bitlis Eren University

Eligibility Criteria

Inclusion Criteria

  • Two months or longer elapsed since the stroke,
  • A Mini-Mental State Examination score of 24 or higher,
  • The ability to stand independently for 20 seconds or more,
  • The ability to walk independently for 10 meters with the use of walking aids or orthoses if necessary,
  • Being between 45 and 75 years of age,
  • Having a Brunnstrom stage of 4 or above

Exclusion Criteria

  • The presence of severe osteoarthritis in the lower extremity,
  • The presence of cancer or diabetic neuropathy,
  • The presence of vestibular disorder,
  • The presence of lower extremity ulceration or amputation,
  • History of vertigo,
  • Alcohol consumption within the last 24 hours,
  • Hemodynamic instability,
  • Diagnosis of posterior circulation stroke involving the basilar artery and cerebellum,
  • The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
  • Having experienced an acute lower extremity injury in the last six weeks,

Outcomes

Primary Outcomes

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

  • Mediolateral Stability Index Measurement(Change from baseline mediolateral stability immediately after intervention)
  • Anteroposterior Stability Index Measurement(Change from baseline anteroposterior stability immediately after intervention)
  • Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions(Change from baseline ankle dorsiflexion range of motion immediately after intervention)

Study Sites (1)

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