Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle

Sponsor

Real Fundación Victoria Eugenia (Other)

Overall Status

Completed

CT.gov ID

NCT02825667

Collaborator

(none)

Enrollment

Arms

12.5

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Haemophilia	Other: Physiotherapy sessions	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 12, 2016

Actual Primary Completion Date :

Sep 8, 2017

Actual Study Completion Date :

Sep 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Patients included in this group will receive treatment over a period of three weeks, receiving 3 physiotherapy sessions lasting approximately 30 minutes each. The treatment program includes 8 maneuvers that must be administered bilaterally: maneuver longitudinal sliding on the fascial surface plant, maneuver induction of the plantar fascia, maneuver longitudinal surface sliding on the anterolateral compartment of the leg, induction maneuver ankle anterior compartment, maneuver pressure and sliding on the posterior region of the leg, technical release of the popliteal fascia, maneuver induction sural triceps, and lower extremity telescopic technique.	Other: Physiotherapy sessions Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy
No Intervention: Control group Patients included in this group will not receive any physiotherapy treatment. However, will be evaluated under the same conditions that patients in the experimental group (pretreatment evaluation, post-treatment and follow-up).

Arm

Intervention/Treatment

Experimental: Experimental group

Patients included in this group will receive treatment over a period of three weeks, receiving 3 physiotherapy sessions lasting approximately 30 minutes each. The treatment program includes 8 maneuvers that must be administered bilaterally: maneuver longitudinal sliding on the fascial surface plant, maneuver induction of the plantar fascia, maneuver longitudinal surface sliding on the anterolateral compartment of the leg, induction maneuver ankle anterior compartment, maneuver pressure and sliding on the posterior region of the leg, technical release of the popliteal fascia, maneuver induction sural triceps, and lower extremity telescopic technique.

Other: Physiotherapy sessions

Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy

No Intervention: Control group

Patients included in this group will not receive any physiotherapy treatment. However, will be evaluated under the same conditions that patients in the experimental group (pretreatment evaluation, post-treatment and follow-up).

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Age [Screening visit]
Age of patients
Weight [Screening visit]
Weight of patients included in the study
Height [Screening visit]
Height of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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.