Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle

NCT02825667 | Completed

• 1 other identifier: AnHe-Fascial
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Haemophilia

Keywords

Haemophilia; Ankle; Arthropathy; Pain; Range of motion; Myofascial techniques

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Age

  Screening visit

• Weight

  Screening visit

• Height

  Screening visit

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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).

Interventions

Physiotherapy sessions OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Real Fundación Victoria Eugenia: lead

MeSH Terms

Conditions

Hemophilia A; Joint Diseases; Pain

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Real Fundación Victoria Eugenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 7, 2016
• Study Start: September 12, 2016
• Primary Completion: September 8, 2017
• Study Completion: September 26, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share