Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy
1 septembre 2021 mis à jour par: Investigación en Hemofilia y Fisioterapia
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.
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.
Aperçu de l'étude
Type d'étude
Interventionnel
Inscription (Réel)
58
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Comunity Of Madrid
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Madrid, Comunity Of Madrid, Espagne, 28670
- Universidad Europea de Madrid
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- Patients diagnosed with hemophilia A and B disease.
- Over 18 years.
- Diagnosed with hemophilic arthropathy of the ankle (by clinical assessment with the Hemophilia Joint Health Score).
- On prophylactic or on demand treatment with FVIII / FIX concentrates.
Exclusion Criteria:
- Patients without ambulation ability.
- Patients with inhibitors (antibodies to FVIII or FIX).
- Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests.
- Not signed the informed consent document.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Libération auto-myofasciale
Chaque séance durera environ 15 minutes, avec cinq séances de physiothérapie se déroulant sur une période de 3 mois.
Le protocole de libération auto-myofasciale des membres inférieurs à l'aide d'un rouleau en mousse et d'un massage à billes solides, adapté aux patients atteints d'arthropathie hémophile de la cheville, comprendra 11 exercices qui doivent être administrés de manière bilatérale.
Une application mobile sera développée où chaque patient pourra observer les exercices à réaliser.
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The Self-Myofascial release protocol for the lower limbs using a Foam Roller will include: Self-Myofascial release of the plantar region using and Solid Ball Massage; release of the myofascial components of the back of the leg using a Foam Roller; release of the myofascial components of the anterior part of the leg using a Foam Roller; release of myofascial components of the hamstring region using a Foam Roller; release of the myofascial components of the adductor muscles using a Solid Ball Massage in a sitting position; release of the myofascial components of the abductor muscles using a Foam Roller in lateral decubitus; and release of the myofascial components of the pelvitrochanteric muscles using a Foam Roller in a sitting position.
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Aucune intervention: Control
Patients included in the control group will not receive any physiotherapy intervention.
They will continue with their routine prior to the beginning of the study.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline ankle joint pain after treatment and at 3 months
Délai: Screening visit, within the first seven days after treatment and after three months follow-up visit
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Visual analogic scale (VAS).
This scale will be used to evaluate the perception of joint pain, where ankle joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).
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Screening visit, within the first seven days after treatment and after three months follow-up visit
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline ankle joint pain after treatment and at 3 months
Délai: Screening visit, within the first seven days after treatment and after three months follow-up visit
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Pressure algometer.
Measuring instrument used to evaluate pressure joint pain.
The instrument shall consist of a measuring device attached to a hard rubber tip 1.1 cm in diameter.
Its sphere shall be calibrated in kg/cm2 with divisions of 0.1 kg/cm2.
The pressure algometry methodology applied was based mainly on the study by Hogeweg.
Before taking the measurements, patients will be instructed to say "yes" as soon as pressure exerted by the algometer becomes slightly unpleasant.
The pressure algometer shall be kept perpendicular to the surface of the skin with the right hand, stabilizing the axis of the instrument using the thumb and index finger of the left hand.
The pressure shall be increased at a uniform rate of approximately 1 kg/cm2 per second.
As soon as the subject, according to the instructions, says "yes", the pressure will be stopped and the score will be noted.
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Screening visit, within the first seven days after treatment and after three months follow-up visit
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Change from baseline lower limb functionality after treatment and at 3 months
Délai: Screening visit, within the first seven days after treatment and after three months follow-up visit
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Hemophilia Joint Health Score (HJHS).
This measuring instrument will be used to evaluate the joint condition of knees, ankles, and elbows.
It includes 8 items (inflammation and its duration, pain, atrophy and muscle strength, crepitus, and reduced flexion and extension) ranging from 0 to 20 points per joint (the higher the score, the greater the joint deterioration).
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Screening visit, within the first seven days after treatment and after three months follow-up visit
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Change from baseline range of motion of ankle after treatment and at 3 months
Délai: Screening visit, within the first seven days after treatment and after three months follow-up visit
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Digital Goniometry Ankle ROM shall be measured using a digital goniometer.
The assessment can be made with the patient standing.
This measuring instrument allows more accurate measurements than those obtained with a universal plastic goniometer.
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Screening visit, within the first seven days after treatment and after three months follow-up visit
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Change from baseline muscle strength after treatment and at 3 months
Délai: Screening visit, within the first seven days after treatment and after three months follow-up visit
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Dynamometry.
The maximum isometric strength of the flexor and extensor muscles of the main joints affected in hemophilia (knees and ankles) will be evaluated on both limbs with a manual dynamometer using a mark test.
For this test, the rater needs to keep the dynamometer stationary while the patient exerts maximum force against it.
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Screening visit, within the first seven days after treatment and after three months follow-up visit
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Change from baseline muscle flexibility after treatment and at 3 months
Délai: Screening visit, within the first seven days after treatment and after three months follow-up visit
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Fingertip-to-Floor Test.
This test is used to assess the degree of flexibility of the posterior muscles of the lower limbs.
This value is calculated as the distance between the fingertip and the floor when maximum hip flexion with knee extension is performed.
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Screening visit, within the first seven days after treatment and after three months follow-up visit
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Collaborateurs et enquêteurs
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Publications et liens utiles
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
2 février 2020
Achèvement primaire (Réel)
26 juin 2020
Achèvement de l'étude (Réel)
15 décembre 2020
Dates d'inscription aux études
Première soumission
11 avril 2019
Première soumission répondant aux critères de contrôle qualité
11 avril 2019
Première publication (Réel)
16 avril 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 septembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 septembre 2021
Dernière vérification
1 septembre 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- He-Foam
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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