RBR-9sfgs9 Foot orthoses in the prevention injury in runners

Date of registration: 07/18/2019 ^(mm/dd/yyyy)
Last approval date : 07/18/2019 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1214-1985

• Public title:

  en

  Foot orthoses in the prevention injury in runners

  pt-br

  Palmilhas na prevenção de lesão em corredores

• Scientific acronym:

  en

  EFOPIRR

  pt-br

  EPPLCR

• Public acronym:

  en

  EFOPIRR

  pt-br

  EPPLCR

• Secondaries identifiers:
  • 82345817.2.0000.5662 - CAAE
    Issuing authority: Plataforma Brasil
  • 2621166
    Issuing authority: Comitê de Ética em Pesquisa do Instituto de Ciências da Saúde - UFBA - CEP

Sponsors

• Primary sponsor: Universidade Federal da Bahia
• Secondary sponsor:
  • Institution: Cristiano Sena da Conceição
• Supporting source:
  • Institution: Universidade Federal da Bahia

Health conditions

• Health conditions:

  en

  Tendinopathy; Fractures, bone; Muscle Fatigue; Arthralgia

  pt-br

  Tendinopatia; Fraturas Ósseas; Fadiga Muscular; Artralgia

• General descriptors for health conditions:

  en

  C05 Musculoskeletal diseases

  pt-br

  C05 Doenças musculoesqueléticas

  es

  C05 Enfermedades musculoesqueléticas

• Specific descriptors:

Interventions

• Interventions:

  en

  Intervention group (N=128): Insole to control the pronation, supination, and distribution of the load on the feet used for at least 04 hours daily and during the practice of running. Control group (N=128): Sham insole (flat insole made with Ethyl Vinyl Acetate of 3mm)

  pt-br

  Grupo intervenção (N=128): Palmilha para controle da pronação, supinação e distribuição da carga nos pés usada por no mínimo 04 horas diárias e durante a prática de corrida Grupo controle(N=128): Palmilha Sham (palmilha plana produzida em Etil Vinil Acetato de 3mm)

• Descriptors:

  en

  E07.858.442.743 Orthotic Devices

  pt-br

  E07.858.442.743 Aparelhos Ortopédicos

  es

  E07.858.442.743 Aparatos Ortopédicos

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 05/16/2018 ^(mm/dd/yyyy)
• Date last enrollment: 12/31/2019 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  256	-	18 Y	65 Y

• Inclusion criteria:

  en

  Individuals with no running-related injury history in the last 3 months, and who have been running for at least 4 months without interruption for at least 1 time per week.

  pt-br

  Indivíduos sem histórico de lesões relacionadas à corrida nos últimos 3 meses, e que correram por pelo menos 4 meses sem interrupção por pelo menos 1 vez por semana.

• Exclusion criteria:

  en

  Individuals who presented history of surgeries at the lower end and those who refused to sign the informed consent form.

  pt-br

  Indivíduos que apresentaram histórico de cirurgias na extremidade inferior e aqueles que se recusaram a assinar o termo de consentimento livre e esclarecido.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Prevention	Parallel	2	Triple-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  To investigate the interaction between the type of insole and the appearance of injuries related to running.

  pt-br

  Investigar a interação entre o tipo de palmilha e o surgimento de lesões relacionadas a corrida.

• Secondary outcomes:

  en

  Check the effect of the use of insoles on lower limb strength and tread pattern of recreational runners. Describe the type of footfall and isokinetic muscle strength of the lower limbs in recreational runners.

  pt-br

  Verificar o efeito do uso das palmilhas na força dos membros inferiores e no padrão de pisada de corredores recreacionais. Descrever o tipo de pisada e a força muscular isocinética dos membros inferiores em corredores recreacionais.

Contacts

• Public contact
  • Full name: Cristiano Sena da Conceição
  • • Address: Av. Alphaville, n 825. Cond. Garden ville, edf Hortência, apt 1103
    • City: Salvador / Brazil
    • Zip code: 41701-015
  • Phone: +55(71)81315747
  • Email: cristianosena@gmail.com
  • Affiliation: Escola Bahiana de Medicina e Saúde pública
   
• Scientific contact
  • Full name: Renata Santana Barbosa
  • • Address: Avenida Alphaville, 634, torre 3, 804
    • City: Salvador / Brazil
    • Zip code: 41701-015
  • Phone: 7133315110
  • Email: renathafisio@hotmail.com
  • Affiliation: Universidade Federal da Bahia
   
• Site contact
  • Full name: Cristiano Sena da Conceição
  • • Address: Av. Alphaville, n 825. Cond. Garden ville, edf Hortência, apt 1103
    • City: Salvador / Brazil
    • Zip code: 41701-015
  • Phone: +55(71)81315747
  • Email: cristianosena@gmail.com
  • Affiliation: Escola Bahiana de Medicina e Saúde pública
   

Additional links:

• Download in ICTRP format