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| ID | Type | Description | Link |
|---|---|---|---|
| HOLISTIC |
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Multidisciplinary assessment of the physical, functional and psychosocial alterations in patients with hemophilia around the country. The aims of this study are:
Observational study that will allow us:
Analyze and evaluate the skeletal muscle of patients with hemophilia involvement.
Describe the periarticular muscular deficit, depending on the degree of injury, age, presence of inhibitors and the development of physical activity.
Identify the relationship between the functional deficit by clinical assessment performed with the use of validated scales measure force production with patients.
Observe the presence of joint bleeds in children with hemophilia and synovial hypertrophy developing therein.
Detect biomechanical abnormalities of the lower limbs and their impact on gait in patients with hemophilia.
Assess the factors that influence the perception of illness and quality of life of patients with hemophilia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables. | ||
| Control group | Children without hemophilia |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess the Joint Damage | Measurement with Haemophilia Joint Health Score 2.1 (HJHS) | Screening visit |
| Assess the Perception of Quality of Life | Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE). | Screening visit |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Clinical Patient Variables | Hemophilia type measuring (A or B) | Screening visit |
| Measure of Weight | Measure of weight | Screening visit (pretreatment assessment) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with haemophilia attending hemophilia shelters organized by the Federación Española de Hemofilia (Fedhemo) in the Centro de Formación Permanente en Hemofilia La Charca (Murcia, Spain).
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| Name | Affiliation | Role |
|---|---|---|
| Rubén Cuesta-Barriuso, PhD | Catholic University San Antonio of Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Murcia | Murcia | Murcia | 30100 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients | Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables. |
| FG001 | Control Group | Children without hemophilia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients | Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables. |
| BG001 | Control Group | Children without hemophilia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assess the Joint Damage | Measurement with Haemophilia Joint Health Score 2.1 (HJHS) | Haemophilia Joint Health Score assesses joint health in patients with hemophilia. It consists of eight dimensions: swelling, muscular atrophy, crepitation and range of motion, joint pain, strength, motion and axial alignment. The score range is from 0 to 24 points (a score of 0 indicates no joint damage. The higher the score, the higher). | Posted | Mean | Standard Deviation | points | Screening visit |
|
Serious and Other (Not Including Serious) Adverse Events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients | Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rubén Cuesta-Barriuso | Real Fundación Victoria Eugenia | +34913146508 | ruben.cuestab@gmail.com |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Children without hemophilia
|
|
| Primary | Assess the Perception of Quality of Life | Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE). | The score ranges from 0 (poor QoL) to 100 points (good perception of QoL). | Posted | Mean | Standard Deviation | points | Screening visit |
|
|
|
| Secondary | Assessment of Clinical Patient Variables | Hemophilia type measuring (A or B) | Posted | Number | Percentage of Participants with Hemophil | Screening visit |
|
|
|
| Secondary | Measure of Weight | Measure of weight | Posted | Mean | Standard Deviation | Kg | Screening visit (pretreatment assessment) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Group | Children without hemophilia | 0 | 0 | 0 | 0 |
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009140 | Musculoskeletal Diseases |