Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy.

NCT04549402 | Unknown

• 1 other identifier: HeMirror
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Haemophilia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline hemarthrosis after treatment and at 2 months

  A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous) and location (knee, ankle or elbow). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).

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

Secondary Outcomes (9)

• Change from baseline joint pain after treatment and at 2 months

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

• Change from baseline pressure pain threshold after treatment and at 2 months

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

• Change from baseline muscle strength after treatment and at 2 months

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

• Change from baseline electrical activity of the muscles after treatment and at 2 months

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

• Change from baseline perception of quality of life after treatment and at 2 months

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

Study Arms (3)

Mirror Therapy group

EXPERIMENTAL

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).

Other: Mirror Therapy group

Video group

ACTIVE COMPARATOR

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).

Other: Video group

Control group

NO INTERVENTION

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.

Interventions

Mirror Therapy group OTHER

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.

Mirror Therapy group

Video group OTHER

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

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
• 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

You may not qualify if:

• Patients with neurological or cognitive disorders that impede understanding of the questionnaires
• 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

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

European University of Madrid

Madrid, 28670, Spain

RECRUITING

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

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

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: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: August 31, 2021
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)