Virtual Action Planning in Stroke: a Control Rehabilitation Study

Study Overview
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Brief Summary
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Background : The general experience with the Virtual Reality application approach suggests that this treatment concept is promising in stroke rehabilitation Purpose : In shopping activity in a real supermarket and in simulated with the investigators virtual shopping simulation (VAP-S = virtual action planning supermarket), the investigators will compare people who had undergone a stroke who receive conventional rehabilitation or virtual training in VAP-S.

Detailed Description
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The objective of this study is firstly to examine the effectiveness of using virtual reality-based training VAP-S on the ability to run errands in a real supermarket in individuals with stroke. Virtual environment provide useful way to explore planning and secondly to examine the effectiveness of using VR in the assessment of cognitive planning for patients. A virtual supermarket was designed in which participants carried out a task close to daily activities: a test of shopping list. Of the 70 subjects (7 centres), 35 randomly allocated to the control group, and the other 35 subjects randomly allocated to the experimental group. Subjects will be evaluated by a therapist who will not be involved in the training program and did not know about the subject's group assignment. Statistical analysis : We will calculate descriptive statistics for the clinical characteristics of each group. We will use to compare the baseline demographic characteristics, the pretraining and posttraining variables between groups, independent-samples t-tests for means and Chi-square tests for frequencies. A significance level of 0.05 is set for all analyses.

Official Title
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Effectiveness of Virtual Reality-based Cognitive Training in Daily Living in Stroke Patients Using Virtual Action Planning Supermarket (VAP-S)

Conditions
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Stroke

Intervention / Treatment
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* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 1 to 18 months after stroke Without dementia or previous clinical stroke With executive impairment (Grefex battery) Barthel score equal or more than 40 With cognitive disability leading to specific rehabilitation Given and informed consent Exclusion Criteria: dementia or severe psychiatric disease epilepsy disorder of consciousness visual agnosia severe visual impairment

Ages Eligible for Study
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Minimum Age: 18 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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality-based cognitive training<br> | Other: Rehabilitation<br>* The experimental group patients receive rehabilitation by training Virtual Action Planning - Supermarket on a computer 45 minutes 5 times a week during a 2-week period. The control group will receive similar duration cognitive rehabilitation (no extra computer training) during this period (problem solving and occupational therapy).<br>|
| Active Comparator: Cognitive rehabilitation (without extra computer training)<br> | Other: Rehabilitation<br>* The experimental group patients receive rehabilitation by training Virtual Action Planning - Supermarket on a computer 45 minutes 5 times a week during a 2-week period. The control group will receive similar duration cognitive rehabilitation (no extra computer training) during this period (problem solving and occupational therapy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to perform shopping test in real supermarket (all items collected and all actions needed done) |  | After rehabilitation (day 16) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to perform all actions in real shop; performance in virtual shopping simulation (number of items, time, inappropriate actions); user and caregiver satisfaction. |  | Before (day 1) and after (day16) rehabilitation |