Movement Visualization in Patients With Hemophilic Arthropathy
NCT ID: NCT04237766
Last Updated: 2020-01-27
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
140 participants
INTERVENTIONAL
2020-05-01
2021-05-01
Brief Summary
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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.
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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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Experimental group
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.
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).
Control group
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.
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Medical diagnosis of hemophilic arthropathy
* Chronic joint pain
* Over 18 years
* On prophylactic treatment or on demand with FVIII / FIX concentrates
Exclusion Criteria
* 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.
18 Years
65 Years
MALE
Yes
Sponsors
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Real Fundación Victoria Eugenia
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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He-Mirror
Identifier Type: -
Identifier Source: org_study_id
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