Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy

Haemophilia Clinical Trial

Official title:

Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy. A Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05425888
• Other study ID #: He-AnkleCon
• Status: Completed
• Start date: June 22, 2022
• Est. completion date: December 23, 2022

Study information

• Verified date: February 2024
• Source: Investigación en Hemofilia y Fisioterapia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 23, 2022
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with hemophilia A and B.
• Over 18 years.
• With medical diagnosis of ankle arthropathy.
• With clinical evaluation by Hemophilia Joint Health Score.
• In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
• No previous hemarthrosis of the ankles in the 3 months prior to evaluation.

Exclusion Criteria:

• Patients with inhibitors (antibodies against FVIII or FIX).
• Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests.
• Failure to sign the informed consent document

Related Conditions & MeSH terms

• Haemophilia
• Joint Diseases

Intervention

Other:
• Hemophilia group
Evaluation of the study variables: dorsal flexion; dorsiflexion strength; tibialis anterior muscle activation; biomechanical analysis of gait and balance; and functionality.

Locations

Country	Name	City	State
Spain	Universidad Católica San Antonio	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Investigación en Hemofilia y Fisioterapia	Real Fundación Victoria Eugenia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the dorsal flexion with numerical scale of range of motion	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.	Screening visit
Primary	Assess the dorsiflexion strength with dynamometry	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.	Screening visit
Secondary	Assess the biomechanical analysis of gait and balance with pressure platform	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	Screening visit
Secondary	Assess the functionality with pressure platform	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.	Screening visit