Virtual Action Planning in Stroke: a Control Rehabilitation Study

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Rehabilitation

• Registration Number: NCT01365858
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-30
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-12
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual reality-based cognitive training	Rehabilitation	-
Cognitive rehabilitation (without extra computer training)	Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Ability to perform shopping test in real supermarket (all items collected and all actions needed done)	After rehabilitation (day 16)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Chu Rennes; 🇫🇷 Rennes, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

Ap-Hp Garches; 🇫🇷 Garches, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Chu Nancy; 🇫🇷 Nancy, France

Centre Mutualiste Rééducation et de Réadaptation Fonctionnelle de Kerpape LORIENT; 🇫🇷 Ploemer, France

Chu Saint-Etienne; 🇫🇷 Saint-etienne, France