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Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy

1. september 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

58

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Comunity Of Madrid
      • Madrid, Comunity Of Madrid, Spanien, 28670
        • Universidad Europea de Madrid

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Selv-myofascial frigivelse
Hver session varer cirka 15 minutter, med fem fysioterapisessioner over en periode på 3 måneder. Den Self-Myofascial frigivelsesprotokol for underekstremiteterne ved hjælp af en Foam Roller og Solid Ball Massage, tilpasset til patienter med hæmofil ankelarthropati, vil omfatte 11 øvelser, der skal administreres bilateralt. Der vil blive udviklet en mobilapplikation, hvor hver patient vil kunne observere de øvelser, der skal udføres.
Andet: Self-Myofascial release
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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline ankle joint pain after treatment and at 3 months
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline ankle joint pain after treatment and at 3 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Investigación en Hemofilia y Fisioterapia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. februar 2020

Primær færdiggørelse (Faktiske)

26. juni 2020

Studieafslutning (Faktiske)

15. december 2020

Datoer for studieregistrering

Først indsendt

11. april 2019

Først indsendt, der opfyldte QC-kriterier

11. april 2019

Først opslået (Faktiske)

16. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • He-Foam

Plan for individuelle deltagerdata (IPD)

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