Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle

Haemophilia Clinical Trial

Official title:

Randomized Clinical Study on the Effectiveness of the Myofascial Therapy in the Treatment of the Hemophilic Arthropathy of Ankle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825667
• Other study ID #: AnHe-Fascial
• Status: Completed
• Phase: N/A
• First received: June 30, 2016
• Last updated: September 26, 2017
• Start date: September 12, 2016
• Est. completion date: September 26, 2017

Study information

• Verified date: September 2017
• Source: Real Fundación Victoria Eugenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 26, 2017
• Est. primary completion date: September 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A
• Joint Diseases

Intervention

Other:
• Physiotherapy sessions
Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Real Fundación Victoria Eugenia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline bleeding frequency after treatment and at 5 months	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.	Screening visit, within the first seven days after treatment and after five months follow-up visit
Primary	Change from baseline joint pain of ankle after treatment and at 5 months	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).	Screening visit, within the first seven days after treatment and after five months follow-up visit
Primary	Change from baseline joint function after treatment and at 5 months	Change from joint health during treatment and follow-up period at 5 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).	Screening visit, within the first seven days after treatment and after five months follow-up visit
Primary	Change from baseline range of motion after treatment and at 5 months	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	Screening visit, within the first seven days after treatment and after five months follow-up visit
Secondary	Age	Age of patients	Screening visit
Secondary	Weight	Weight of patients included in the study	Screening visit
Secondary	Height	Height of patients	Screening visit