Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy

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

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.

Study Overview

• Status: Completed
• Conditions: Haemophilia
• Intervention / Treatment: Other: Hemophilia group

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain
    • Universidad Católica San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemophilia group; Group of adult patients with hemophilia, diagnosed with bilateral hemophilic ankle arthropathy	Other: Hemophilia group; Evaluation of the study variables: dorsal flexion; dorsiflexion strength; tibialis anterior muscle activation; biomechanical analysis of gait and balance; and functionality.
Control group; Group of healthy subjects with sociodemographic characteristics similar to patients with hemophilia, diagnosed with bilateral hemophilic ankle arthropathy.	Other: Hemophilia group; Evaluation of the study variables: dorsal flexion; dorsiflexion strength; tibialis anterior muscle activation; biomechanical analysis of gait and balance; and functionality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Investigación en Hemofilia y Fisioterapia
• Collaborators: Real Fundación Victoria Eugenia
• Investigators: Principal Investigator: Rubén Cuesta-Barriuso, PhD, University of Oviedo

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Actual): November 18, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Functionality; Proprioception; Range of motion; Joint pain; Ankle; Hemophilic arthropathy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: He-AnkleCon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No