RBR-2yprts Effectiveness of tele-rehabilitation compared to traditional physiotherapy in the treatment of stroke

Date of registration: 01/23/2018 ^(mm/dd/yyyy)
Last approval date : 01/23/2018 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1205-2411

• Public title:

  en

  Effectiveness of tele-rehabilitation compared to traditional physiotherapy in the treatment of stroke

  pt-br

  Efetividade da telereabilitacão comparada com tradicional fisioterapia no tratamento de Acidente Vascular encefálico

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 69255817.9.1001.5054
    Issuing authority: Plataforma Brasil
  • 2.266.801
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal do Ceará

Sponsors

• Primary sponsor: Universidade Federal do Ceara
• Secondary sponsor:
  • Institution: Universidade Federal de Goias
  • Institution: Universite de Montreal
• Supporting source:
  • Institution: O Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Health conditions

• Health conditions:

  en

  Stroke

  pt-br

  Acidente Vascular Cerebral

• General descriptors for health conditions:

  en

  I00-I99 IX - Diseases of the circulatory system

  pt-br

  I00-I99 IX - Doenças do aparelho circulatório

• Specific descriptors:

Interventions

• Interventions:

  en

  Group 1 with 26 participants (control) with home physical therapy and group 2 with 26 participants (treated by telereabilitation). Telerehabilitation intervention for 12 weeks and consists of exercises, five days a week, using a system of videos recorded with protocol of progressive exercises that will be executed at the residences of the participants who do not have access to health services due to mobility problems.

  pt-br

  grupo 1 (controle) com tratamento fisioterapêutico presencial domiciliar e grupo 2 (tratado por telereabilitação). Participants: 26 Intervencao e 26 grupo controle A intervenção telereabilitação tem a duração de 12 semanas e consiste na prática de exercícios, cinco dias por semana, utilizando um sistema de vídeos gravados com protocolo de exercícios progressivos que será executado nas residências dos usuários que não possuem condições de locomoção e, portanto, não têm acesso aos serviços de saúde.

• Descriptors:

  en

  E02.779 Physical Therapy Modalities

  pt-br

  E02.779 Modalidades de Fisioterapia

  es

  E02.779 Modalidades de Fisioterapia

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 02/02/2018 ^(mm/dd/yyyy)
• Date last enrollment: 04/01/2018 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  52	-	18 -	0 -

• Inclusion criteria:

  en

  volunteer with age of 18 years or more; presence of caregiver; and recent stroke defined as a diagnosis of stroke within four weeks.

  pt-br

  voluntarios com idade maior ou igual a 18 anos; presença de cuidador; e AVE recente definida como diagnóstico de acidente vascular encefalico dentro de quatro semanas.

• Exclusion criteria:

  en

  Cognitive deficits established by the minimum score of 20, through the Montreal Cognitive Assessment (MoCA); cognitive assessment tool; users who did not sign the Informed Consent Form (TCLE); excessive spasticity in the affected upper extremity defined by the score> 3 by the Modified Ashworth Spasticity Scale.

  pt-br

  Déficits cognitivos estabelecidos pelo escore mínimo de 20; através do instrumento de avaliação da cognição Montreal Cognitiva Assessment (MoCA); usuários que não assinaram o Termo de consentimento Livre Esclarecido (TCLE); excessiva espasticidade na extremidade superior acometida definida pelo escore > 3 pelo Modified Ashworth Spasticity Scale.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Open	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Clinically important differences for the upper-extremity Fugl-Meyer Scale. the smallest change in a treatment outcome that an individual patient would identify as important and which would mandate a change in the patient's management.

  pt-br

  Diferenca clinica minima da escala de Fugl-Meyer. Menor mudancao referida pelo participante referida como importante e usada para mudancas no tratamento do participante.

• Secondary outcomes:

  en

  improvement of oxidative stress. Measures before and after intervention.

  pt-br

  Qualquer melhora do estresse oxidativo. Medido através de exames laboratoriais feitos na 1 semana pré e pós-intervenção

  en

  Any changes for level of functionality according to the Disability Assessment Scale (WHODAS 2.0)

  pt-br

  Qualquer mudanca no nível de funcionalidade segundo a Escala de avaliação de Incapacidade (WHODAS 2.0)

  en

  cost-effectiveness of this telerehabilitation program compared to the conventional therapy.

  pt-br

  Custo- eficácia deste programa de telereabilitação comparada com o tratamento convencional.

Contacts

• Public contact
  • Full name: Jose Carlos Tatmatsu-Rocha
  • • Address: Rua Alexandre Baraúna, 949
    • City: Fortaleza / Brazil
    • Zip code: 60430160
  • Phone: +55 086 33668632
  • Email: tatmatsu@gmail.com
  • Affiliation: Universidade Federal do Ceara
   
• Scientific contact
  • Full name: Jose Carlos Tatmatsu-Rocha
  • • Address: Rua Alexandre Baraúna, 949
    • City: Fortaleza / Brazil
    • Zip code: 60430160
  • Phone: +55 086 33668632
  • Email: tatmatsu@gmail.com
  • Affiliation: Universidade Federal do Ceara
   
• Site contact
  • Full name: Jose Carlos Tatmatsu-Rocha
  • • Address: Rua Alexandre Baraúna, 949
    • City: Fortaleza / Brazil
    • Zip code: 60430160
  • Phone: +55 086 33668632
  • Email: tatmatsu@gmail.com
  • Affiliation: Universidade Federal do Ceara
   

Additional links:

• Download in ICTRP format