Clinical trial NCT01365858: Virtual Action Planning in Stroke: a Control Rehabilitation Study
Official title: Effectiveness of Virtual Reality-based Cognitive Training in Daily Living in Stroke Patients Using Virtual Action Planning Supermarket (VAP-S)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ability to perform shopping test in real supermarket (all items collected and all actions needed done)
timeFrame: After rehabilitation (day 16)
Secondary outcomes:
measure: Time to perform all actions in real shop; performance in virtual shopping simulation (number of items, time, inappropriate actions); user and caregiver satisfaction.
timeFrame: Before (day 1) and after (day16) rehabilitation
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Garches
country: France
facility: Ap-Hp Garches
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nancy
country: France
facility: Chu Nancy
city: Ploemer
country: France
facility: Centre Mutualiste Rééducation et de Réadaptation Fonctionnelle de Kerpape LORIENT
city: Rennes
country: France
facility: Chu Rennes
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: University Hospital, Bordeaux
name: Geneviève CHENE, Pr
role: STUDY_CHAIR
affiliation: University Hospital, Bordeaux
name: Pierre-Alain JOSEPH, Pr
role: PRINCIPAL_INVESTIGATOR
References: