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Clinical Trials/NCT01365858
NCT01365858
Completed
Not Applicable

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

University Hospital, Bordeaux7 sites in 1 country29 target enrollmentMay 2011
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University Hospital, Bordeaux
Enrollment
29
Locations
7
Primary Endpoint
Ability to perform shopping test in real supermarket (all items collected and all actions needed done)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

  • 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

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
February 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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
  • disorder of consciousness
  • visual agnosia
  • severe visual impairment

Outcomes

Primary Outcomes

Ability to perform shopping test in real supermarket (all items collected and all actions needed done)

Time Frame: After rehabilitation (day 16)

Secondary Outcomes

  • 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)

Study Sites (7)

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