The Impact of Using an Interactive System, a Paper and Pencil Program or Conventional Methodologies in the Rehabilitation of Stroke Patients: a Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidade da Madeira
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change from baseline in the Montreal Cognitive Assessment
Study Overview
Brief Summary
Virtual Reality allows the integration of both cognitive and motor rehabilitation in a more ecologically valid context. The purpose of this study is to determine whether this methodology has more impact on stroke rehabilitation than a paper and pencil personalised program and conventional therapy, which is motor-focused.
Detailed Description
Cognitive impairments after stroke are not always given sufficient attention despite its limitations in activities-of-daily- living (ADL's). Current cognitive rehabilitation methods mostly rely on paper-and-pencil tasks targeting isolated domains, which is not consistent with everyday-life. Besides limited ecological-validity, paper-and-pencil tasks are not accessible for most stroke patients whose dominant arm is paretic. Virtual Reality (VR) has shown to be a solution for the development of accessible and ecologically valid systems, but, does it have more impact than a paper and pencil personalised intervention?
Through a participatory design approach, with health professionals, the investigators have developed:
- a motor-accessible and cognitive-personalized VR-based system, where conventional cognitive tasks were operationalized in meaningful simulations of ADL's (Reh@City) and;
- a web tool which generates personalised paper and pencil tasks( Task Generator).
The investigators objective is to have a sample of 60 stroke patients between 40 and 70 years old, randomly allocated in three groups: the experimental group 1 were participants will perform 30 minutes of the VR training with Reh@City; the experimental group 2 were participants will perform 30 minutes of the paper and pencil training with the Task Generator, and the control group were participants will perform 30 minutes of conventional therapy (occupational therapy).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ischemic stroke with more than 6 months post-stroke
- •cognitive deficit but with enough capacity to understand the task and follow instructions with a minimum score of 11 over 17 in the Token Test (6-item version, Portuguese population)
- •able to read and write
Exclusion Criteria
- •Severe depressive symptoms as assessed by the Beck Depression Inventory
Arms & Interventions
Virtual Reality
The Virtual Reality group will perform personalised activities of daily living in the context of a simulated city (Reh@City). The interaction with the virtual environment will be through a natural user interface.
Intervention: Virtual Reality (Procedure)
Paper and Pencil
The paper and pencil group will perform a set of cognitive paper and pencil tasks personalised to their deficits and generated automatically through a Task Generator.
Intervention: Paper and Pencil (Procedure)
Conventional Therapy
The Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused.
Intervention: Conventional Therapy (Procedure)
Outcomes
Primary Outcomes
Change from baseline in the Montreal Cognitive Assessment
Time Frame: Baseline, End (4-6 weeks) and 8-weeks follow-up
Secondary Outcomes
- Change from baseline in the Trail Making Test A and B(Baseline, End (4-6 weeks) and 8-weeks follow-up)
- Change from baseline in the Verbal Paired Associates (WMS III)(Baseline, End (4-6 weeks) and 8-weeks follow-up)
- Change from baseline in the Digit Span (WAIS III)(Baseline, End (4-6 weeks) and 8-weeks follow-up)
- Change from baseline in the Symbol Search and Coding (WAIS III)(Baseline, End (4-6 weeks) and 8-weeks follow-up)
Investigators
Sergi Bermúdez i Badia
Professor Auxiliar
Universidade da Madeira