Clinical trial NCT05425888: Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy
Official title: Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy. A Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemophilia
Keywords: Hemophilic arthropathy
Ankle
Joint pain
Functionality
Range of motion
Proprioception
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
Collaborators: name: Real Fundación Victoria Eugenia
First posted: 2022-06-21
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assess the dorsal flexion with numerical scale of range of motion
timeFrame: Screening visit
measure: Assess the dorsiflexion strength with dynamometry
timeFrame: Screening visit
Secondary outcomes:
measure: Assess the biomechanical analysis of gait and balance with pressure platform
timeFrame: Screening visit
measure: Assess the functionality with pressure platform
timeFrame: Screening visit
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio
Study officials:
affiliation: University of Oviedo
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: