HaemophiliaNCT02825667
Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle
A study testing Physiotherapy sessions in people with Haemophilia, run by Real Fundación Victoria Eugenia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Haemophilia
- What is being tested?
- Physiotherapy sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2016to 26 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Randomized Clinical Study on the Effectiveness of the Myofascial Therapy in the Treatment of the Hemophilic Arthropathy of Ankle
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
- Being tested
- Physiotherapy sessions
- Keywords
- Haemophilia, Ankle, Arthropathy, Pain, Range of motion, Myofascial techniques
- Medical subject headings
- Hemophilia A, Joint Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy sessionsOther
Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: Screening visit, within the first seven days after treatment and after five months follow-up visit
Secondary outcomes (3)
Age
Age of patients
Measured: Screening visit
Weight
Weight of patients included in the study
Measured: Screening visit
Height
Height of patients
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start12 Sep 2016
- Primary completion8 Sep 2017
- Study completion26 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Fundación Victoria Eugenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Real Fundación Victoria Eugenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825667
- Sponsor's protocol ID
- AnHe-Fascial
- Status last verified
- Sep 2017
- First submitted
- 30 Jun 2016
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study on the Effectiveness of the Myofascial Therapy in the Treatment of the Hemophilic Arthropathy of Ankle
- ClinicalTrials.gov ID
- NCT02825667
- Acronym / sponsor ID
- AnHe-Fascial
- Conditions
- Haemophilia
- Keywords
- Haemophilia, Ankle, Arthropathy, Pain, Range of motion, Myofascial techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Real Fundación Victoria EugeniaUniversity, hospital or other
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Physiotherapy sessionsPatients 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy sessionsPhysiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy | Other | Experimental group |
Primary outcome
Change from baseline bleeding frequency after treatment and at 5 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
3 secondary outcomes
Age
Time frame: Screening visit
Weight
Time frame: Screening visit
Height
Time frame: Screening visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubén Cuesta-Barriuso, PhD principal investigator
Real Fundación Victoria Eugenia
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy sessions in people with Haemophilia, run by Real Fundación Victoria Eugenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline bleeding frequency after treatment and at 5 months (time frame: Screening visit, within the first seven days after treatment and after five months follow-up visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.