A Randomised Controlled Trial Comparing the Impact of Virtual Reality, Paper and Pencil and Conventional Methods on Stroke Rehabilitation

Recruiting

Phase N/A Results N/A

Trial Description

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).

Conditions

Interventions

  • Conventional therapy Other
    Intervention Desc: Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
    ARM 1: Kind: Experimental
    Label: Conventional Therapy
    Description: The Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused.
  • Virtual Reality Device
    Intervention Desc: Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
    ARM 1: Kind: Experimental
    Label: Virtual Reality
    Description: 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.
  • Paper and Pencil Procedure
    Intervention Desc: Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
    ARM 1: Kind: Experimental
    Label: Paper and Pencil
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in the Montreal Cognitive Assessment Baseline, End (4-6 weeks) and 8-weeks follow-up No
Primary Change from baseline in the Stroke Impact Scale 3.0 Baseline, End (4-6 weeks) and 8-weeks follow-up No
Primary Change from baseline in the Positive and Negative Affect Schedule Baseline, End (4-6 weeks) and 8-weeks follow-up No
Secondary Change from baseline in the Trail Making Test A and B Baseline, End (4-6 weeks) and 8-weeks follow-up No
Secondary Change from baseline in the Verbal Paired Associates (WMS III) Baseline, End (4-6 weeks) and 8-weeks follow-up No
Secondary Change from baseline in the Digit Span (WAIS III) Baseline, End (4-6 weeks) and 8-weeks follow-up No
Secondary Change from baseline in the Symbol Search and Coding (WAIS III) Baseline, End (4-6 weeks) and 8-weeks follow-up No

Sponsors