Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy. (HeMirror)

Investigación en Hemofilia y Fisioterapia

Status: Unknown

Conditions: Haemophilia

Treatments: Other: Mirror Therapy group; Other: Video group

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04549402

HeMirror

Details and patient eligibility

About

Background. The recurrence of hemarthrosis in patients with hemophilia favors the development of a progressive, degenerative intra-articular lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of this arthropathy.

Objective. Assess the safety and efficacy of a pain intervention by visualizing movement using an augmented reality mobile application and immersive 360º video, regarding the frequency of bleeding and the improvement in pain perception and quality of life, joint condition , strength and functionality in patients with hemophilic arthropathy.

Study design. Randomized, multicenter, single-blind clinical study. Method. 70 patients with hemophilia A and B will be recruited in this study. The patients will be recruited in 5 regions of Spain. The 8 dependent variables will be: frequency of bleeding (self-registration), pain (measured with the visual analog scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire of Anxiety Status-Trait-STAI), joint status (Hemophilia Joint Health Score scale), muscle strength (dynamometer) and functionality (6-Minutes Walking test, Quick Disabilities of the arm, shoulder and hand). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 6 months.

Expected results. To observe the efficacy of the visualization of movement in the characteristics of pain, and its implication in the functionality, joint state, muscular strength and the perception of quality of life in patients with hemophilic arthropathy.

Enrollment: 70 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients diagnosed with hemophilia A and B
• Patients with a medical diagnosis of hemophilic arthropathy and pain
• People over 18 years of age
• Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates

Exclusion criteria

• Patients with neurological or cognitive disorders that impede understanding of the questionnaires
• Pain free patients
• Amputees, epileptics or patients with severe vision problems
• Patients who are receiving Physiotherapy treatment at the time of the study
• Patients who have not signed the informed consent document

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 3 patient groups

Mirror Therapy group

Experimental group

Description:

The intervention will consist of the visualization of movement through the Mirror Therapy VR® application, broadcast on a mobile device and visualized with virtual reality glasses. The knee extension and ankle dorsiflexion movements (quadriceps and sural triceps), together with the elbow flexion (elbow flexors) will be the movements to be performed, based on their functional need (walking and feeding, respectively).

Treatment:

Other: Mirror Therapy group

Video group

Active Comparator group

Description:

The intervention will consist of the visualization of movement through the reproduction of an immersive 360º video broadcast on a mobile device and viewed with virtual reality glasses. Knee extension and ankle dorsiflexion movements (quadriceps and sural triceps), together with elbow flexion (elbow flexors) will be the movements to be performed, based on their functional need (ambulation and feeding, respectively).

Treatment:

Other: Video group

Control group

No Intervention group

Description:

Patients included in the control group will not receive any physiotherapy intervention. They will continue with their routine prior to the beginning of the study.