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Trial to assess the bilateral deficit phenomenon during dynamic plantar flexion task in patients with haemophilic arthropathy Describe the differences in terms of the physical variables (muscular strength, range of motion and proprioception) in patients with hemophilia who have conducted a home treatment with a digital tool.
Bookmark the relationship between clinical history of joint bleeds and clinical manifestations in standing and walking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with haemophilia | Assessment of bilateral deficit phenomenon during dynamic plantar flexion task |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with haemophilia | Other | Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Bilateral Index of Maximal Peak Force | Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA). | Screening visit |
| Assessment of Bilateral Index of Rate of Development During the Preparation Phase | Assessment of Bilateral index of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | Screening visit |
| Assessment of Bilateral Index of Rate of Development During the Acceleration Phase | Assessment of bilateral index of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | Screening visit |
| Assessment of Maximal Peak Force | Assessment of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | Screening visit |
| Assessment of Rate of Development During the Preparation Phase | Assessment of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | Screening visit |
| Change of Joint Condition Based on Clinical Assessment | Spanish version of the Haemophilia Joint Health Score 2.1 (HJHS). Additive scale that assesses from 0 to 24 points joint status of patients with haemophilia (0: no joint damage; 24: maximum joint damage). The variables studied in this scale are: Swelling (range 0-3); Duration of swelling (range 0-1); Muscle atrophy (range 0-2); Crepitant in motion (range 0-2); Loss of Flexion (range 0-3); Loss of extension (range 0-3); Joint pain (range 0-2): Strength (range 0-4); Gait (range 0-4) |
| Measure | Description | Time Frame |
|---|---|---|
| Weight of the Patients With Haemophilia | The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA) | Screening visit |
| Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with haemophilia
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| Name | Affiliation | Role |
|---|---|---|
| JUAN JOSE RODRIGUEZ, MsC | Universidad Católica San Antonio | Study Chair |
| RUBEN CUESTA-BARRIUSO, PhD | Universidad Católica San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica San Antonio, Murcia | Murcia | Murcia | 30107 | Spain |
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Patients with haemophilia
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Haemophilia | Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Haemophilia | Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) |
| 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 | Assessment of Bilateral Index of Maximal Peak Force | Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA). | Bilateral rates was calculated during the preparation phase and during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions. Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is "[100x (bilateral) / (right unilateral + left unilateral)] - 100" | Posted | Mean | Standard Deviation | percentage | Screening visit |
|
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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 With Haemophilia | Assessment of bilateral deficit phenomenon during dynamic plantar flexion task Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rubén Cuesta-Barriuso, PhD | Universidad Católica San Antonio de Murcia | +34 913146508 | 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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| ID | Term |
|---|---|
| C005044 | hydroxyethyl methacrylate |
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| Screening visit |
| Assessment of Rate of Development During the Acceleration Phase | Assessment of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | Screening visit |
| Assessment of Maximal Velocity of Movement | Assessment of maximal velocity of movement with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | Screening visit |
Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy). |
| Screening visit |
| Joint Bleeding Before the Assessment | Screening visit |
| Height of the Patients With Haemophilia | The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA). | Screening visit |
| Body Mass Index of Patients With Haemophilia | The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA). | Screening visit |
| Age of Patients With Haemophilia | Screening visit |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Assessment of Bilateral Index of Rate of Development During the Preparation Phase | Assessment of Bilateral index of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | Bilateral rates was calculated during the preparation phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is "[100x (bilateral) / (right unilateral + left unilateral)] - 100" | Posted | Mean | Standard Deviation | percentage | Screening visit |
|
|
|
| Primary | Assessment of Bilateral Index of Rate of Development During the Acceleration Phase | Assessment of bilateral index of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | Bilateral rates was calculated during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is "[100x (bilateral) / (right unilateral + left unilateral)] - 100" | Posted | Mean | Standard Deviation | percentage | Screening visit |
|
|
|
| Primary | Assessment of Maximal Peak Force | Assessment of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | The maximum peak force (MPF) is defined as the maximum achieved in the force-time curve during the dynamic test plantar flexion for both bilateral conditions as right and left unilateral, normalized to body weight of the participants (N / kg value) | Posted | Mean | Standard Deviation | N/kg | Screening visit |
|
|
|
| Primary | Assessment of Rate of Development During the Preparation Phase | Assessment of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | Posted | Mean | Standard Deviation | N/s | Screening visit |
|
|
|
| Primary | Change of Joint Condition Based on Clinical Assessment | Spanish version of the Haemophilia Joint Health Score 2.1 (HJHS). Additive scale that assesses from 0 to 24 points joint status of patients with haemophilia (0: no joint damage; 24: maximum joint damage). The variables studied in this scale are: Swelling (range 0-3); Duration of swelling (range 0-1); Muscle atrophy (range 0-2); Crepitant in motion (range 0-2); Loss of Flexion (range 0-3); Loss of extension (range 0-3); Joint pain (range 0-2): Strength (range 0-4); Gait (range 0-4) | Posted | Mean | Standard Deviation | Units on a scale (range 0-24) | Screening visit |
|
|
|
| Primary | Assessment of Rate of Development During the Acceleration Phase | Assessment of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | Posted | Mean | Standard Deviation | N/s | Screening visit |
|
|
|
| Primary | Assessment of Maximal Velocity of Movement | Assessment of maximal velocity of movement with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA) | The maximum speed (Vmax) was calculated as the maximum value of the first integral of the force-time curve for bilateral contractions, left-sided and right-sided | Posted | Mean | Standard Deviation | m/s | Screening visit |
|
|
|
| Secondary | Weight of the Patients With Haemophilia | The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA) | Posted | Mean | Standard Deviation | Kg | Screening visit |
|
|
|
| Secondary | Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand) | Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy). | Posted | Number | participants | Screening visit |
|
|
|
| Secondary | Joint Bleeding Before the Assessment | Posted | Number | participants | Screening visit |
|
|
|
| Secondary | Height of the Patients With Haemophilia | The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA). | Posted | Mean | Standard Deviation | cm | Screening visit |
|
|
|
| Secondary | Body Mass Index of Patients With Haemophilia | The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA). | Posted | Mean | Standard Deviation | kg/m2 | Screening visit |
|
|
|
| Secondary | Age of Patients With Haemophilia | Posted | Mean | Standard Deviation | years | Screening visit |
|
|
|
| 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 |
| Title | Measurements |
|---|---|
|
| Left ankle |
|
| Title | Measurements |
|---|---|
|
| Moderate haemophilia |
|
| Mild haemophilia |
|
| Prophylaxis treatment |
|
| On demand treatment |
|