Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04549402
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2020-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy.
Sponsor:
Investigación en Hemofilia y Fisioterapia
Organization:
Study Overview
Official Title:
Efficacy of a Physiotherapy Intervention Through Movement Visualization in Pain Management in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HeMirror
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: