Movement Visualization in Patients With Hemophilic Arthropathy

NCT04237766 | Unknown

• 1 other identifier: He-Mirror
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hemophilic arthropathy; Educative intervention; Pain; Quality of life; Anxiety; Stress

Outcome Measures

Primary Outcomes (1)

• Change from baseline joint bleeding frequency after treatment and at 6 months

  A self-registration of hemorrhages will be used to assess the frequency of bleeding, and with it the safety of the technique. In the self-registration of bleeding, which will be delivered to each patient at the beginning of the study, the patient must fill in the number of hemarthrosis and the main characteristics of these: date, origin (traumatic or spontaneous) and location (knee, ankle or elbow). The self-registration will be delivered to the evaluator in each of the evaluations of the study (post-treatment and follow-up).

  Screening visit, within the first seven days after treatment and after six months follow-up visit

Secondary Outcomes (11)

• Change from baseline joint pain after treatment and at 6 months

  Screening visit, within the first seven days after treatment and after six months follow-up visit

• Change from baseline joint pain perception after treatment and at 6 months

  Screening visit, within the first seven days after treatment and after six months follow-up visit

• Change from baseline muscle strength after treatment and at 6 months

  Screening visit, within the first seven days after treatment and after six months follow-up visit

• Change from baseline electrical muscle activity after treatment and at 6 months

  Screening visit, within the first seven days after treatment and after six months follow-up visit

• Change from baseline perception of quality of life after treatment and at 6 months

  Screening visit, within the first seven days after treatment and after six months follow-up visit

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: Experimental group

Control group

NO INTERVENTION

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.

Interventions

Experimental group OTHER

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).

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Real Fundación Victoria Eugenia: lead

MeSH Terms

Conditions

Hemophilia A; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Cuesta-Barriuso

CONTACT

+34 913146508; ruben.cuestab@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 23, 2020
• Study Start: May 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: May 1, 2021
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share