Haemophilia
Conditions
Keywords
Haemophilia, Ankle, Arthropathy, Pain, Range of motion, Myofascial techniques
Brief summary
Randomized clinical trial to assess the efficacy of a treatment protocol applied fascial therapy in patients with hemophilic arthropathy ankle, oriented to know and describe the observed differences on the dependent variables: range of motion, pain and physical condition. At the same time, the study will determine whether there are adverse effects or bleeding complications as a result of applied physiotherapy treatment.
Interventions
OTHERPhysiotherapy sessions
Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy
Sponsors
Real Fundación Victoria Eugenia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients diagnosed with hemophilia A and B * Adults patients * Patients with hemophilic arthropathy of ankle diagnosed * Patients in prophylactic treatment regimen or on demand treatment with concentrates of FVIII/FIX.
Exclusion criteria
* Patients without ambulation * Patients diagnosed with other congenital coagulopathy (eg, Von Willebrand disease) * Patients who have developed antibodies to FVIII / FIX (inhibitors) * Patients with neurological or cognitive impairments that prevent understanding of questionnaires and test physical * Patients that have not signed the informed consent document.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline bleeding frequency after treatment and at 5 months | Screening visit, within the first seven days after treatment and after five months follow-up visit | Evaluation of the frequency of muscle and joint bleeds through registration. The frequency of bleeding of the ankle joint is measured with a registry given to patients at the beginning of the study. |
| Change from baseline joint pain of ankle after treatment and at 5 months | Screening visit, within the first seven days after treatment and after five months follow-up visit | Change from joint pain of ankle during treatment and follow-up period at 5 months. The perception of ankle pain will be measured using visual analog scale (scale 0-10). |
| Change from baseline joint function after treatment and at 5 months | Screening visit, within the first seven days after treatment and after five months follow-up visit | Change from joint health during treatment and follow-up period at 5 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20). |
| Change from baseline range of motion after treatment and at 5 months | Screening visit, within the first seven days after treatment and after five months follow-up visit | Change from range of movement of ankle and knee during treatment and follow-up period at 5 months. The range of motion of the ankle joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by Felipe Querol. Measurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height | Screening visit | Height of patients |
| Age | Screening visit | Age of patients |
| Weight | Screening visit | Weight of patients included in the study |
Outcome results
None listed