title: Methodology of the Stroke Self-Management Rehabilitation Trial: an international, multisite pilot trial.
abstract: BACKGROUND
  Stroke is a major cause of long-term adult disability with many survivors living in the community relying on family members for on-going support. However, reports of inadequate understanding of rehabilitation techniques are common. A self-management DVD-based observational learning tool may help improve functional outcomes for survivors of stroke and reduce caregivers' burden.
  
  
  OBJECTIVE
  This article describes the methodology of the stroke self-management rehabilitation trial. The overall aim of this pilot trial is to assess the feasibility and preliminary efficacy of a DVD-based intervention for improving functional outcomes of survivors of stroke 2 months postrandomization to inform the design of a full-scale randomized clinical trial.
  
  
  METHODS
  Recruitment of a minimum of 20 survivors of stroke and their informal caregivers (where available) in each of the participating centers will occur across multiple international sites. After baseline assessments, participants will be randomly assigned to an intervention or standard care group. The intervention comprises a structured DVD observation and practice schedule over 8 weeks. All participants will complete follow-up assessments.
  
  
  RESULTS
  The outcome measures will include a global shift in the Rankin Scale scores and dichotomized scores, changes in quality of life, general health, depression, and caregiver burden at 2 months postrandomization. A qualitative analysis of the effects of the intervention will also be undertaken.
  
  
  CONCLUSIONS
  The results of the pilot study will provide knowledge of whether observational learning techniques delivered via DVD can effectively improve recovery after stroke and reduce caregiver burden.
authors.affiliation: National Institute for Stroke and Applied Neurosciences, School of Rehabilitation and Occupation Studies, Faculty of Health and Environmental Studies, Auckland University of Technology, Auckland, New Zealand. Electronic address: kejones@aut.ac.nz.
authors.forename: Kelly M
authors.initials: KM
authors.lastname: Jones
authors.affiliation: National Institute for Stroke and Applied Neurosciences, School of Rehabilitation and Occupation Studies, Faculty of Health and Environmental Studies, Auckland University of Technology, Auckland, New Zealand.
authors.forename: Rohit
authors.initials: R
authors.lastname: Bhattacharjee
authors.affiliation: National Institute for Stroke and Applied Neurosciences, School of Rehabilitation and Occupation Studies, Faculty of Health and Environmental Studies, Auckland University of Technology, Auckland, New Zealand.
authors.forename: Rita
authors.initials: R
authors.lastname: Krishnamurthi
authors.affiliation: School of Medicine (SOM: Rehab), Emory University, Atlanta, Georgia.
authors.forename: Sarah
authors.initials: S
authors.lastname: Blanton
authors.affiliation: National Institute for Stroke and Applied Neurosciences, School of Rehabilitation and Occupation Studies, Faculty of Health and Environmental Studies, Auckland University of Technology, Auckland, New Zealand.
authors.forename: Alice
authors.initials: A
authors.lastname: Theadom
authors.affiliation: Department of Psychology, The University of Auckland, Auckland, New Zealand.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Barker-Collo
authors.affiliation: Department of Medicine, School of Clinical Sciences, Monash University, Victoria, Australia.
authors.forename: Amanda
authors.initials: A
authors.lastname: Thrift
authors.affiliation: National Institute for Stroke and Applied Neurosciences, School of Rehabilitation and Occupation Studies, Faculty of Health and Environmental Studies, Auckland University of Technology, Auckland, New Zealand.
authors.forename: Priya
authors.initials: P
authors.lastname: Parmar
authors.affiliation: Griffith Health Institute, Gold Coast Campus, Griffith University, Queensland, Australia.
authors.forename: Annick
authors.initials: A
authors.lastname: Maujean
authors.affiliation: Department of Neurology, Palmerston North Hospital, New Zealand; Department of Medicine, University of Otago-Wellington, New Zealand.
authors.forename: Annemarei
authors.initials: A
authors.lastname: Ranta
authors.affiliation: Department of Medicine, University of Ilorin, Ilorin, Nigeria.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Sanya
authors.affiliation: National Institute for Stroke and Applied Neurosciences, School of Rehabilitation and Occupation Studies, Faculty of Health and Environmental Studies, Auckland University of Technology, Auckland, New Zealand.
authors.forename: Valery L
authors.initials: VL
authors.lastname: Feigin
mesh_terms: D017028:Caregivers; D002985:Clinical Protocols; D006801:Humans; D010865:Pilot Projects; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D000071939:Stroke Rehabilitation
keywords: Stroke; clinical trials; methodology; protocols; rehabilitation; treatment