Back to resultsEffectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle
Primary Purpose
Haemophilia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physiotherapy sessions
Sponsored by
About this trial
This is an interventional treatment trial for Haemophilia focused on measuring Haemophilia, Ankle, Arthropathy, Pain, Range of motion, Myofascial techniques
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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.
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).
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).
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
Secondary Outcome Measures
Age
Age of patients
Weight
Weight of patients included in the study
Height
Height of patients
Full Information
NCT ID
NCT02825667
First Posted
June 30, 2016
Last Updated
September 26, 2017
Sponsor
Real Fundación Victoria Eugenia
1. Study Identification
Unique Protocol Identification Number
NCT02825667
Brief Title
Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle
Official Title
Randomized Clinical Study on the Effectiveness of the Myofascial Therapy in the Treatment of the Hemophilic Arthropathy of Ankle
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 12, 2016 (Actual)
Primary Completion Date
September 8, 2017 (Actual)
Study Completion Date
September 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Real Fundación Victoria Eugenia
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia
Keywords
Haemophilia, Ankle, Arthropathy, Pain, Range of motion, Myofascial techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Physiotherapy sessions
Intervention Description
Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy
Primary Outcome Measure Information:
Title
Change from baseline bleeding frequency after treatment and at 5 months
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after five months follow-up visit
Title
Change from baseline joint pain of ankle after treatment and at 5 months
Description
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).
Time Frame
Screening visit, within the first seven days after treatment and after five months follow-up visit
Title
Change from baseline joint function after treatment and at 5 months
Description
Change from joint health during treatment and follow-up period at 5 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).
Time Frame
Screening visit, within the first seven days after treatment and after five months follow-up visit
Title
Change from baseline range of motion after treatment and at 5 months
Description
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
Time Frame
Screening visit, within the first seven days after treatment and after five months follow-up visit
Secondary Outcome Measure Information:
Title
Age
Description
Age of patients
Time Frame
Screening visit
Title
Weight
Description
Weight of patients included in the study
Time Frame
Screening visit
Title
Height
Description
Height of patients
Time Frame
Screening visit
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén Cuesta-Barriuso, PhD
Organizational Affiliation
Real Fundación Victoria Eugenia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle
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