Virtual Action Planning in Stroke: a Control Rehabilitation Study

Stroke Clinical Trial

— VAPS REHAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365858
• Other study ID #: CHUBX 2009/25
• Status: Completed
• Phase: N/A
• First received: May 30, 2011
• Last updated: November 12, 2014
• Start date: May 2011
• Est. completion date: February 2014

Study information

• Verified date: November 2014
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Rehabilitation
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).

Locations

Country	Name	City	State
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 Rennes	Rennes
France	Chu Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to perform shopping test in real supermarket (all items collected and all actions needed done)		After rehabilitation (day 16)	No
Secondary	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	No