NCT04237766

Movement Visualization in Patients With Hemophilic Arthropathy

Safety and Effectiveness of a Physiotherapy Intervention Through Movement Visualization in the Approach of Pain in Patients With Hemophilic Arthropathy. Multicenter Randomized Clinical Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Real Fundación Victoria Eugenia · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Hemophilia

Interventions

Type	Name	Description
OTHER	Experimental group	The intervention will consist of the visualization of the movement through the Mirror Therapy application, or through the reproduction of an immersive 360º video emitted on a mobile device and visualized with virtual reality glasses. The movements observed with both technologies will be the same. The knee extension and dorsal ankle flexion movements (quadriceps and triceps sural), together with the elbow flexion (elbow flexors) will be the movements to be performed, based on their functional need (ambulation and feeding, respectively).

Timeline

• Start date: 2020-05-01
• Primary completion: 2020-10-01
• Completion: 2021-05-01
• First posted: 2020-01-23
• Last updated: 2020-01-27