HemophiliaNCT05104164
Self-myofascial Release in Hemophilic Ankle Arthropathy
A study testing Self-myofascial release in people with Hemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- Self-myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2020to 30 Dec 2020
- 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 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Being over 18 years old
- Patients with a medical diagnosis of hemophilia A or B.
- Patients with a severe phenotype of hemophilia (<1% FVIII/FIX).
- Patients with a medical diagnosis of hemophilic ankle arthropathy and more than 3 points on the Hemophilia Joint Health Score.
- Nno scheduled orthopedic surgeries during the study phase.
- Signing the informed consent document.
Who cannot join
- Patients with ankle hemarthrosis in the month before the beginning of the study.
- Patients unable to walk even with technical aids.
- Patients with hemophilic elbow arthropathy that prevented the performance of the exercises.
- Patients failing to complete at least 80% of the sessions scheduled in the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy. A Randomized Clinical Trial.
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.
Design. A randomized clinical trial. Aimed: To evaluate the safety and effectiveness of a protocol by self-myofascial release with Foam Roller applied in patients with hemophilic ankle arthropathy.
Read more
Patients: 70 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in 5 centers, from different regions of Spain.
Intervention: Each session will last approximately 15 minutes, with five physiotherapy sessions per week for a period of 3 months. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 months. The treatment program includes 11 exercises that must be administered bilaterally. A mobile application will be developed where each patient will be able to observe the exercises to be carried out.
Measuring instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Haemophilia Joint Health Score (joint status); dynamometer assess (muscle strength); 6-Minute Walking test (functionality of lower limbs); Mobile device (Activity record); Finger-floor test (muscle flexibility). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, functionality and joint motion is expected.
- Conditions
- Hemophilia
- Being tested
- Self-myofascial release
- Keywords
- Hemophilic arthropathy, Ankle, Self-myofascial release, Safety, Joint pain, Functionality
- Medical subject headings
- Hemophilia A, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-myofascial releaseOther
At home, the patients performed a daily session, lasting 15 minutes each, over 8 weeks. Patients accessed an ad hoc mobile application designed by the Hemophilia Physiotherapy research group (He-Foam®). This app, accessible from any smartphone, made it possible to watch the videos with all the exercises included in the intervention. The seven exercises under the specific protocol for patients with hemophilic arthropathy were: Self-release of the plantar region of the foot with a foam ball; Release of the posterior region of the leg with the foam roller; Release of the anterior leg region with a foam roller; Release of the hamstrings region with a foam roller; Release of adductor muscles with a foam ball; Release of abductor muscles with a foam roller; Release of pelvic trochanteric muscles with a foam roller
| Study group | Role | What they receive |
|---|---|---|
| Self-myofascial release | Experimental | Each session will last approximately 15 minutes, with five physiotherapy sessions taking place over a period of 3 months. The Self-Myofascial release protocol for the lower limbs using a Foam Roller and and Solid Ball Massage, adapted to patients with hemophilic ankle arthropathy will include 11 exercises that must be administered bilaterally. A mobile application will be developed where each patient will be able to observe the exercises to be carried out. Receives: Other: Self-myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline ankle bleeding after treatment and at 3 months
The safety of the intervention was evaluated through periodic monitoring of the development of ankle hemarthrosis. The physiotherapist in charge of evaluating the patients performed weekly follow-up telephone calls during the experimental phase to evaluate the development of ankle hemarthrosis or other complications (bruising). Bleeding-related data were collected by the evaluator after the follow-up period.
Measured: Screening visit, within the first seven days after treatment and after three months follow-up visit
Secondary outcomes (3)
Change from baseline ankle pain after treatment and at 3 months
The intensity of joint pain was assessed using the visual analog scale (VAS). This scale rates ankle joint pain with scores from zero to 10 points (from no pain to the maximum perceived pain).
Measured: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline range of ankle motion after treatment and at 3 months
The range of ankle motion in dorsal and plantar flexion was measured with a universal goniometer, with one-degree increments. The patient was placed in a supine position, with the axis of the goniometer on the lateral malleolus and the fixed arm of the goniometer parallel to the fibula. This procedure was accompanied by verbal stimulus to the patient to control the compensatory movement of the toes and the range of movement of the talocrural joint. The unit of measurement is the degrees (the higher the mark, the better the range of motion).
Measured: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline functional capacity after treatment and at 3 months
Functional capacity was measured with the 6-Minute Walk test, using the standardization described by the American Thoracic Society. The test was performed on a flat, hard, straight, 20-m long surface. Before the test, the evaluator instructed each patient to walk the track twice to familiarize themselves with the test and warm up. The evaluating physiotherapist used standardized verbal stimuli during the test with all subjects. Patients were asked to walk at a constant speed, without jumping or running, for 6 minutes. To measure the exact distance walked during the test the physiotherapist closely followed the patients with a stopwatch.
Measured: Screening visit, within the first seven days after treatment and after three months follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start2 Sep 2020
- Primary completion27 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104164
- Sponsor's protocol ID
- He-FoamAnk
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05104164
- Acronym / sponsor ID
- He-FoamAnk
- Conditions
- Hemophilia
- Keywords
- Hemophilic arthropathy, Ankle, Self-myofascial release, Safety, Joint pain, Functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 2 Nov 2021 (actual)
- 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.
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.
Design. A randomized clinical trial. Aimed: To evaluate the safety and effectiveness of a protocol by self-myofascial release with Foam Roller applied in patients with hemophilic ankle arthropathy.
Patients: 70 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in 5 centers, from different regions of Spain.
Intervention: Each session will last approximately 15 minutes, with five physiotherapy sessions per week for a period of 3 months. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 months. The treatment program includes 11 exercises that must be administered bilaterally. A mobile application will be developed where each patient will be able to observe the exercises to be carried out.
Measuring instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Haemophilia Joint Health Score (joint status); dynamometer assess (muscle strength); 6-Minute Walking test (functionality of lower limbs); Mobile device (Activity record); Finger-floor test (muscle flexibility). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, functionality and joint motion is expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-myofascial release | Experimental | Other: Self-myofascial releaseEach session will last approximately 15 minutes, with five physiotherapy sessions taking place over a period of 3 months. The Self-Myofascial release protocol for the lower limbs using a Foam Roller and and Solid Ball Massage, adapted to patients with hemophilic ankle arthropathy will include 11 exercises that must be administered bilaterally. A mobile application will be developed where each patient will be able to observe the exercises to be carried out. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being over 18 years old
- Patients with a medical diagnosis of hemophilia A or B.
- Patients with a severe phenotype of hemophilia (<1% FVIII/FIX).
- Patients with a medical diagnosis of hemophilic ankle arthropathy and more than 3 points on the Hemophilia Joint Health Score.
- Nno scheduled orthopedic surgeries during the study phase.
Key exclusion criteria (4 listed)
- Patients with ankle hemarthrosis in the month before the beginning of the study.
- Patients unable to walk even with technical aids.
- Patients with hemophilic elbow arthropathy that prevented the performance of the exercises.
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 |
|---|---|---|
| Self-myofascial releaseAt home, the patients performed a daily session, lasting 15 minutes each, over 8 weeks. Patients accessed an ad hoc mobile application designed by the Hemophilia Physiotherapy research group (He-Foam®). This app, accessible from any smartphone, made it possible to watch the videos with all the exercises included in the intervention. The seven exercises under the specific protocol for patients with hemophilic arthropathy were: Self-release of the plantar region of the foot with a foam ball; Release of the posterior region of the leg with the foam roller; Release of the anterior leg region with a foam roller; Release of the hamstrings region with a foam roller; Release of adductor muscles with a foam ball; Release of abductor muscles with a foam roller; Release of pelvic trochanteric muscles with a foam roller | Other | Self-myofascial release |
Primary outcome
Change from baseline ankle bleeding after treatment and at 3 months
Time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
The safety of the intervention was evaluated through periodic monitoring of the development of ankle hemarthrosis. The physiotherapist in charge of evaluating the patients performed weekly follow-up telephone calls during the experimental phase to evaluate the development of ankle hemarthrosis or other complications (bruising). Bleeding-related data were collected by the evaluator after the follow-up period.
3 secondary outcomes
Change from baseline ankle pain after treatment and at 3 months
Time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline range of ankle motion after treatment and at 3 months
Time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline functional capacity after treatment and at 3 months
Time frame: Screening visit, within the first seven days after treatment and after three months follow-up 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 2 Nov 2021.
- 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
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-myofascial release in people with Hemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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 6 inclusion and 4 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 ankle bleeding after treatment and at 3 months (time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit). 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 2 Nov 2021.