Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy

NCT05425888 | Completed

• 1 other identifier: He-AnkleCon
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Haemophilia

Keywords

Hemophilic arthropathy; Ankle; Joint pain; Functionality; Range of motion; Proprioception

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Assess the biomechanical analysis of gait and balance with pressure platform

  Screening visit

• Assess the functionality with pressure platform

  Screening visit

Study Arms (2)

Hemophilia group

Group of adult patients with hemophilia, diagnosed with bilateral hemophilic ankle arthropathy

Other: Hemophilia group

Control group

Group of healthy subjects with sociodemographic characteristics similar to patients with hemophilia, diagnosed with bilateral hemophilic ankle arthropathy.

Other: Hemophilia group

Interventions

Hemophilia group OTHER

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

Control group; Hemophilia group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with hemophilic ankle arthropathy older than 18 years (group of cases). Healthy subjects without ankle joint damage, of the same age range (control groups).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead
• Real Fundación Victoria Eugenia: collaborator

Study Sites (1)

Universidad Católica San Antonio

Murcia, Spain

Location

MeSH Terms

Conditions

Hemophilia A; Arthralgia

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rubén Cuesta-Barriuso, PhD

  University of Oviedo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: June 22, 2022
• Primary Completion: November 18, 2022
• Study Completion: December 23, 2022
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

ES (1)