Movement Visualization in Patients With Hemophilic Arthropathy

Real Fundación Victoria Eugenia

Status: Unknown

Conditions: Hemophilia

Treatments: Other: Experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT04237766

He-Mirror

Details and patient eligibility

About

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

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

Study design. Randomized, multicenter, simple blind clinical study.

Method. 140 patients with hemophilia A and B will be recruited in this study. 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 analogue scale and pressure algometer, Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale), quality of life (SF-12 scale), anxiety (questionnaire Anxiety State-Trait-STAI), joint state (Hemophilia Joint Health Score scale), muscular 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 6-month follow-up period.

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

Enrollment: 140 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients diagnosed with hemophilia A and B
• Medical diagnosis of hemophilic arthropathy
• Chronic joint pain
• Over 18 years
• On prophylactic treatment or on demand with FVIII / FIX concentrates

Exclusion criteria

• Patients with neurological or cognitive disorders that impede the understanding of the questionnaires
• Painless patients
• Amputee, epileptic or seriously impaired vision patients
• Patients 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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140 participants in 2 patient groups

Experimental group

Experimental group

Description:

All patients included in the experimental group should be on prophylactic treatment with factor 8 (FVIII) or factor 9 (FIX) concentrates. Likewise, the factor should be administered on the same day that they receive each movement display therapy treatment sessions. Each session will last approximately 40 minutes, with 7 physiotherapy sessions a week taking place over a period of 4 weeks.

Treatment:

Other: Experimental group

Control group

No Intervention group

Description:

Subjects included in the control group will not receive physical therapy through mirror therapy and motion display. They will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with factor 8 (FVIII) or factor 9 (FIX) concentrates. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study.