Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy
1 de septiembre de 2021 actualizado por: 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.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
58
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Comunity Of Madrid
-
Madrid, Comunity Of Madrid, España, 28670
- Universidad Europea de Madrid
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Liberación auto-miofacial
Cada sesión tendrá una duración aproximada de 15 minutos, con cinco sesiones de fisioterapia durante un período de 3 meses.
El protocolo de Autoliberación Miofascial de miembros inferiores mediante Rodillo de Espuma y Masaje con Bola Sólida, adaptado a pacientes con artropatía hemofílica de tobillo, incluirá 11 ejercicios que deberán administrarse de forma bilateral.
Se desarrollará una aplicación móvil donde cada paciente podrá observar los ejercicios a realizar.
|
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.
|
|
Sin intervención: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline ankle joint pain after treatment and at 3 months
Periodo de tiempo: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
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).
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline ankle joint pain after treatment and at 3 months
Periodo de tiempo: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
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.
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
|
Change from baseline lower limb functionality after treatment and at 3 months
Periodo de tiempo: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
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).
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
|
Change from baseline range of motion of ankle after treatment and at 3 months
Periodo de tiempo: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
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.
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
|
Change from baseline muscle strength after treatment and at 3 months
Periodo de tiempo: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
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.
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
|
Change from baseline muscle flexibility after treatment and at 3 months
Periodo de tiempo: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
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.
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de febrero de 2020
Finalización primaria (Actual)
26 de junio de 2020
Finalización del estudio (Actual)
15 de diciembre de 2020
Fechas de registro del estudio
Enviado por primera vez
11 de abril de 2019
Primero enviado que cumplió con los criterios de control de calidad
11 de abril de 2019
Publicado por primera vez (Actual)
16 de abril de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
1 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- He-Foam
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .