NCT04549402: HeMirror

Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy.

Status unknown NA Last updated 31 March 2022

What this trial tests

NA trial testing Mirror Therapy group in Haemophilia in 70 participants. Status unknown.

Timeline

31 August 2021

Primary endpoint
1 February 2022

1 May 2022

Quick facts

Lead sponsor	Investigación en Hemofilia y Fisioterapia
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	70
Start date	31 August 2021
Primary completion	1 February 2022
Estimated completion	1 May 2022
Sites	1 location across Spain

Drugs / interventions tested

• Mirror Therapy group
• Video group

Conditions studied

• Haemophilia — all drugs for Haemophilia →

Sponsor

Investigación en Hemofilia y Fisioterapia

Who can join

Adults 18 to 65, male only, with Haemophilia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 180-degree immersive VR motion visualization in the treatment of haemophilic ankle arthropathy.
   Ucero-Lozano R, Pérez-Llanes R, López-Pina JA, Cuesta-Barriuso R. · · 2023 · cited 7× · PMID 36261396 · DOI 10.1111/hae.14683
2. One Session Effects of Knee Motion Visualization Using Immersive Virtual Reality in Patients with Hemophilic Arthropathy.
   Ucero-Lozano R, Pérez-Llanes R, López-Pina JA, Cuesta-Barriuso R. · · 2021 · cited 4× · PMID 34682847 · DOI 10.3390/jcm10204725
3. Approach to Knee Arthropathy through 180-Degree Immersive VR Movement Visualization in Adult Patients with Severe Hemophilia: A Pilot Study.
   Ucero-Lozano R, Pérez-Llanes R, López-Pina JA, Cuesta-Barriuso R. · · 2022 · cited 3× · PMID 36294536 · DOI 10.3390/jcm11206216
4. Immersive visualization of movement in patients with hemophilic ankle arthropathy. Multicenter, single-blind, randomized clinical trial.
   Ucero-Lozano R, Pérez-Llanes R, Cuesta-Barriuso R, Donoso-Úbeda E. · · 2024 · PMID 39347694 · DOI 10.2340/jrm.v56.40775