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The Efefcts of Elastic Bandages on Gait Biomechancs, Muscular Performance, Pain, and Physical Function in Individuals with Knee Osteoartritis

Registration Date: April 26, 2012, 10:51 a.m.
Last Update: April 18, 2013, 1:08 p.m.

Study Type:

Intervention Study

Scientific Title:

pt-br

Efeito das Bandagens Elásticas em Variáveis Biomecânicas da Marcha, Sobre o Desempenho Muscular, na Dor e na Função Física de Pessoas com Osteoartrite de Joelhos

en

The Efefcts of Elastic Bandages on Gait Biomechancs, Muscular Performance, Pain, and Physical Function in Individuals with Knee Osteoartritis

Trial Identification

  • UTN Number: U1111-1130-2906
  • Public Title:

    pt-br

    Efeito das Bandagens Elásticas em Pessoas com Osteoartrite dos Joelhos

    en

    The Effects of Elastic Bandagens in People With Knee Arthrosis

  • Scientific Acronym:

  • Public Acronym:

  • Secondary Identifying Numbers:
    • Nº 0368.0.203.000-11 - SISNEP
      Issuing Authority: Comitê de Ética em Pesquisa daUniversidade Federal de Minas Gerais - CAAE

Sponsors

  • Primary Sponsor: Universidade Federal de Minas Gerais
  • Secondary Sponsors:
    • Institution: Universidade Federal de Minas Gerais
  • Source(s) of Monetary or Material Support:
    • Institution: FAPEMIG

Health Conditions

  • Health Condition(s) or Problem(s):

    pt-br

    Osteoartrite de joelho.

    en

    Knee osteoarthritis.

  • General Descriptors for Health Condition(s):

    pt-br

    C05: Doenças musculoesqueléticas

    es

    C05: Enfermedades musculoesqueléticas

    en

    C05: Musculoskeletal diseases

  • Specific Descriptors for Health Condition(s):

    pt-br

    C05.550.114.606: Osteoartrite

    es

    C05.550.114.606: Osteoartritis

    en

    C05.550.114.606: Osteoarthritis

Interventions

  • Intervention Code(s)
    • Other
  • Interventions:

    pt-br

    Será conduzido um ensaio clínico randomizado controlado, dois braços, uni cego (avaliador mascarado). Serão alocadas aleatoriamente para o estudo, 20 mulheres com osteoartrite (OA) de joelho, com idade mínima de 20 e máxima de 90 anos. A sequencia da aleatoriedade será gerada por um programa de computador, contado em blocos de 20 participantes, que serão divididos em dois grupos e mantido em envelopes selados e opacos numa sequencia numérica. Os envelopes serão previamente preparados por um aluno de fisioterapia devidamente treinado e não envolvido no estudo. Os participantes elegíveis serão aleatoriamente alocados em grupos experimentais, sendo: grupo 1 com 10 participantes e grupo 2, também com 10 participantes, após os conteúdos dos envelopes opacos e selados serem revelados pelo fisioterapeuta responsável pela intervenção. As participantes do grupo 1 receberão aplicação de fita adesiva terapêutica - Kinesio Tape sobre o músculo reto femoral e as participantes do grupo 2 receberão aplicação de fita adesiva terapêutica - Kinesio Tape sobre o músculo reto femoral e sobre o músculo glúteo máximo. Portanto, não haverá um grupo placebo. As avaliações serão realizadas antes e após 48 horas das intervenções da fita adesiva terapêutica - Kinesio Tape. As seguintes medidas de desfecho serão obtidas: intensidade da dor, avaliada pela escala visual analógica e a rigidez e função física auto-relatadas pelo questionário Western Ontario and McMaster University (WOMAC). O desempenho muscular será medido pelo dinamômetro isocinético Biodex. Os parâmetros espaço temporais da marcha, medido pelo GaitRite e a mobilidade medida pelo teste Timed Up and Go (TUG).

    en

    Will be driven a randomized controlled trial, two arms, uni blind (evaluator masked). Will be randomized to the study 20 women with osteoarthritis (OA) of the knee, with a minimum age of 20 and maximum of 90 years. The sequence of randomization will be generated by a computer program reckoned in blocks of 20 participants will be divided into two groups and kept in sealed, opaque envelopes in numerical sequence. The envelopes will be prepared in advance by a student of physiotherapy properly trained and not involved in the study. Eligible participants will be randomly assigned to experimental groups: group 1 with 10 participants and group 2, also with 10 participants, after the contents of opaque sealed envelopes were revealed by the physiotherapist responsible for intervention. Group members will receive one application of therapeutic tape - Kinesio Tape on the rectus femoris and the participants of group 2 will receive application of therapeutic tape - Kinesio Tape on the rectus femoris and the gluteus maximus. Therefore, there will be a placebo group. Evaluations shall be performed before and after 48 hours of therapeutic interventions tape - Kinesio Tape. The following outcome measures will be obtained: intensity of pain assessed by visual analog scale stiffness and physical function and self-reported by questionnaire Western Ontario and McMaster University (WOMAC). The muscle performance will be measured by the Biodex isokinetic dynamometer. The spatial and temporal parameters of gait measured by GaitRite and mobility as measured by the Timed Up and Go (TUG).

  • Descriptor for Intervention(s):

    pt-br

    E05.723: Estimulação Física

    es

    E05.723: Estimulación Física

    pt-br

    E07.101: Bandagens

    es

    E07.101: Vendajes

    pt-br

    E07.101.036: Fita Atlética

    es

    E07.101.036: Cinta Atlética

Recruitment

  • Recruitment Status: Recruitment completed
  • Recruitment Country
    • Brazil
  • Planned Date of First Enrollment: 2012-06-01
  • Planned Date of Last Enrollment: 2013-01-31
  • Target Sample Size: Gender (inclusion sex): Inclusion Minimum Age: Inclusion Maximum Age:
    20 F 20 Y 90 Y
  • Inclusion Criteria:

    pt-br

    Mulheres com diagnóstico clínico e radiográfico de osteoartrite (OA) leve e/ou moderada bilateral de joelhos, com marcha independente, sem déficts cognitivos, com índice de massa corporal inferiors a 30Kg/m2 e que não tenha sido submetida à cirurgia em nenhuma das articulações dos membros inferiores.

    en

    Women with mild and moderate clinical and radiographic diagnoses of bilateral knee osteoarthritis (OA), who are able to walk independently, have no cognivite deficits, have a mody mass index below 30kg/m2, and not be submitted to surgery in any joint of the lower limbs.

  • Exclusion Criteria:

    pt-br

    Ausência de dor no dia do experimento, além daquelas que tiverem o movimento completo de uma articulação (ADM) ativa, inferior a 90 graus de flexão no joelho e/ou no quadril e fragilidade cutânea.

    en

    Absence of pain on the day of the experiment, in addition to those who have full movement of a joint (ADM) active, less than 90 degrees of flexion at the knee and/or hip, and skin fragility.

Study Type

  • Study Design:

    pt-br

    Ensaio clínico paralelo, randomizado, unicego com dois braços.

    en

    Parallel single-blinded randomized controlled trial with two arms.

  • Expanded access program Study Purpose Intervention Assignment Number of arms Masking type Allocation type Study Phase
    None Treatment Parallel 2 Single-blind Randomized-controlled N/A

Outcomes

  • Primary Outcomes:

    pt-br

    Mudanças na intensidade da dor serão avaliadas pela escala analógica visual e pela primeira sub-seção do questionário Western Ontario and McMaster University (WOMAC).

    en

    Changes in pain levels will be assessed by the visual analogic scale and by the first sub-section of the Western Ontario and McMaster University (WOMAC) questionnaire.

    pt-br

    Mudanças na função física serão avaliadas pelos parâmetros espaço-temporais da marcha, teste timed up and go (TUG), e pela terceira sub-seção do questionário Western Ontario and McMaster University (WOMAC).

    en

    Changes in physical function will be evaluated by the spatial temporal gait variables, timed up and go (TUG) test, by the third sub-section of the Western Ontario and McMaster University (WOMAC).

  • Secondary Outcomes:

    pt-br

    Medidas de desempenho muscular serão obtidas com o dinamômetro isocinético Biodex.

    en

    Measures of muscular performance will be obtained with the Biodex Isokinetic dynamometer.

Contacts

  • Contacts for Public Queries
    • Full Name: Jennifer Granja Peixoto
      • Address: Avenida Antônio Carlos, 6627- Pampulha
      • City: Belo Horizonte - MG / Brazil
      • Zip Code: 31270-901
    • Telephone: +55(31)3409-7403
    • E-mail:
    • Affiliation: Universidade Federal de Minas Gerais
     
  • Contacts for Scientific Queries
    • Full Name: Jennifer Granja Peixoto
      • Address: Avenida Antônio Carlos, 6627- Pampulha
      • City: Belo Horizonte - MG / Brazil
      • Zip Code: 31270-901
    • Telephone: +55(31)3409-7403
    • E-mail:
    • Affiliation: Universidade Federal de Minas Gerais
     
  • Contact(s) for Site Queries
    • Full Name: Jennifer Granja Peixoto
      • Address: Avenida Antônio Carlos, 6627- Pampulha
      • City: Belo Horizonte - MG / Brazil
      • Zip Code: 31270-901
    • Telephone: +55(31)3409-7403
    • E-mail:
    • Affiliation: Universidade Federal de Minas Gerais
     

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