Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy.
NCT ID: NCT04549402
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2021-08-31
2022-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mirror Therapy group
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).
Mirror Therapy group
The intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected.
Video group
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).
Video group
The intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected.
Control group
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.
No interventions assigned to this group
Interventions
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Mirror Therapy group
The intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected.
Video group
The intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
MALE
Yes
Sponsors
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Investigación en Hemofilia y Fisioterapia
NETWORK
Responsible Party
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Principal Investigators
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Rubén Cuesta-Barriuso, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Europea de Madrid
Locations
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European University of Madrid
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HeMirror
Identifier Type: -
Identifier Source: org_study_id
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