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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Stroke

Intervention / Treatment
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* Procedure: Virtual Reality
* Procedure: Paper and Pencil
* Procedure: Conventional Therapy


Participation Criteria
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Eligibility Criteria
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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: Neglect Severe depressive symptoms as assessed by the Beck Depression Inventory

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>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. | Procedure: Virtual Reality<br>* Intervention of 30 minutes, 3 times a week until reaching 12 sessions.<br>|
| Active Comparator: Paper and Pencil<br>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. | Procedure: Paper and Pencil<br>* Intervention of 30 minutes, 3 times a week until reaching 12 sessions.<br>|
| Active Comparator: Conventional Therapy<br>The Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused. | Procedure: Conventional Therapy<br>* Intervention of 30 minutes, 3 times a week until reaching 12 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Montreal Cognitive Assessment |  | Baseline, End (4-6 weeks) and 8-weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Cognitive Rehabilitation, Motor Rehabilitation, Ecological validity, Personalisation