N/A
Completed N=17
Bilateral Deficit Phenomenon in Patients With Haemophilic Arthropathy
Hemophilia
Source: ClinicalTrials.gov NCT02165462 ↗
Enrolled (actual)
17
Serious AEs
—
Results posted
Dec 2015
Primary outcomePrimary: Assessment of Bilateral Index of Maximal Peak Force — -40.86 percentage
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Bilateral Index of Maximal Peak Force |
-40.86 | — |
| PRIMARY Assessment of Bilateral Index of Rate of Development During the Preparation Phase |
31.34 | — |
| PRIMARY Assessment of Bilateral Index of Rate of Development During the Acceleration Phase |
20.05 | — |
| PRIMARY Assessment of Maximal Peak Force |
15.67 | — |
| PRIMARY Assessment of Rate of Development During the Preparation Phase |
6190.86 | — |
| PRIMARY Change of Joint Condition Based on Clinical Assessment |
4.88; 3.00; 5.82; 6.35 | — |
| PRIMARY Assessment of Rate of Development During the Acceleration Phase |
8945.25 | — |
| PRIMARY Assessment of Maximal Velocity of Movement |
0.48 | — |
| SECONDARY Weight of the Patients With Haemophilia |
73.48 | — |
| SECONDARY Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand) |
15; 2; 7; 5; 5; 8 | — |
| SECONDARY Joint Bleeding Before the Assessment |
7 | — |
| SECONDARY Height of the Patients With Haemophilia |
176.53 | — |
| SECONDARY Body Mass Index of Patients With Haemophilia |
23.36 | — |
| SECONDARY Age of Patients With Haemophilia |
32.47 | — |
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with hemophilia A and B.
- With or without joint involvement clinically diagnosed, and with or without a previous history of hemarthrosis joint load legs.
- In prophylactic regimen with FVIII / FIX concentrates .
- Residents in the Autonomous Community of the Region of Murcia.
Exclusion Criteria
- Patients without walking ability.
- Patients diagnosed with other congenital coagulopathy (von Willebrand disease, etc..).
- Patients with neurological or cognitive impairments that prevent understanding the questionnaires and physical tests.
- Patients whose parents or guardians have not signed the informed consent document.
Data sourced from ClinicalTrials.gov (NCT02165462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.