Universidad Católica San Antonio
Murcia, Spain
NCT Number: NCT05425888
Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations (muscle strength deficit, mobility and proprioception), intra-articular and chronic pain.
Design: Case-control study. Objective: To observe the differences between patients with hemophilic ankle arthropathy and their healthy peers, regarding dorsiflexion, dorsiflexion strength, biomechanical analysis of gait and balance, and functionality.
Patients: 10 patients with hemophilic ankle arthropathy and 12 healthy subjects without ankle joint damage.
Measurement instruments and study variables: dorsiflexion (range of motion), dorsiflexion strength (dynamometry), biomechanical analysis of gait and balance (RS SCAN® model platform), and functionality (2 Minute Walk Test).
Expected results: Analyze the main differences and their relationship based on the clinical and independent variables of patients with hemophilia, compared to their healthy peers.
Looking for future studies?
Notify Me18 year–45 year
Male
Observational
Murcia, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluation of the study variables: dorsal flexion; dorsiflexion strength; tibialis anterior muscle activation; biomechanical analysis of gait and balance; and functionality.
Time frame: Screening visit
Measurement with Leg Motion system. Subjects will stand with the big toe on the starting line and the knee touching a metal stick. The metal rod will move away from the foot up to the maximum ankle dorsiflexion allowed, without taking the heel off the ground and with knee contact on the rod. Three measurements will be made for each ankle and the mean value will be used for data analysis. All measurements will be made with the patient barefoot.
Time frame: Screening visit
The maximal isometric strength of the ankle flexor muscles will be tested. Both extremities will be evaluated with a manual dynamometer (model Lafayette Manual Muscle Tester 01165). The examiner will hold the dynamometer on the sole of the foot while the subject exerts maximal force against it. The unit of measurement of this measurement instrument is the Newton per square centimeter (N/cm2), where the higher the score, the greater the muscle force.
Time frame: Screening visit
It will be evaluated using an Rs Scan® pressure platform and FootScan® pressure measurement system. This scientific version biomechanical examination device measures plantar pressure using an X-Y array of resistive pressure sensitive sensors that are scanned sequentially. The system records pressure data when the subject is standing or walking on the platform. Measurements will be made with the basic 0.5m platform with 4,096 sensors with resistive technology and 300Hz data acquisition frequency. The biomechanics of walking will be analyzed with the analysis of the probes and the static balance in a time of 30 seconds
Time frame: Screening visit
The 2-Minute Walking Test will be used. The functional capacity to exercise, in clinical practice, will be evaluated by means of a modified version, used in populations with pathologies with special characteristics, of the 6-minute version. It will be carried out in a closed corridor, with a length of 30 m delimited between cones. Before the test, participants must rest for at least 10 minutes. Subsequently, they will be instructed to complete the circuit by walking around the cones as fast as possible, but without running, for 2 minutes. They will be allowed to use walking aids, slow down or stop to rest if necessary. The distance covered at the end of the 2 minutes will be recorded by the evaluator. This instrument has shown excellent test-retest reliability.
Investigación en Hemofilia y Fisioterapia
Network
Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy. A Case-control Study
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.
Published trials that share one or more normalized conditions with this study.
NCT02229331
Arthropathy, Blood Coagulation Disorders
View Trial DetailsNCT02866526
Blood Coagulation Disorders, Blood Coagulation Disorders, Inherited
Amiens, France
View Trial DetailsNCT03818529
Blood Coagulation Disorders, Blood Coagulation Disorders, Inherited
Phoenix, Arizona, United States
View Trial DetailsNCT04586101
Blood Coagulation Disorders, Blood Coagulation Disorders, Inherited
Wuppertal, North Rhine-Westphalia, Germany
View Trial Details