Virtual Action Planning in Stroke: a Control Rehabilitation Study (VAPS REHAB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01365858
First received: May 30, 2011
Last updated: May 9, 2014
Last verified: May 2014
  Purpose
  • 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.

Condition Intervention
Stroke
Other: Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Effectiveness of Virtual Reality-based Cognitive Training in Daily Living in Stroke Patients Using Virtual Action Planning Supermarket (VAP-S)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Ability to perform shopping test in real supermarket (all items collected and all actions needed done) [ Time Frame: After rehabilitation (day 16) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to perform all actions in real shop; performance in virtual shopping simulation (number of items, time, inappropriate actions); user and caregiver satisfaction. [ Time Frame: Before (day 1) and after (day16) rehabilitation ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: May 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Virtual reality-based cognitive training 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).
Active Comparator: Cognitive rehabilitation (without extra computer training) 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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365858

Contacts
Contact: Pierre-Alain JOSEPH, Pr pierre-alain.joseph@chu-bordeaux.fr

Locations
France
CHU Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Pierre-Alain JOSEPH, Pr       pierre-alain.joseph@chu-bordeaux.fr   
Principal Investigator: Pierre-Alain JOSEPH, Pr         
Sub-Investigator: Jean-Michel MAZAUX, Pr         
Ap-Hp Garches Recruiting
Garches, France, 92380
Contact: Philippe AZOUVI, Pr       philippe.azouvi@rpc.ap-hop-paris.fr   
Principal Investigator: Philippe AZOUVI, Pr         
Hospices Civils de Lyon Recruiting
Lyon, France, 69424
Contact: Gilles RODE, Pr       gilles.rode@chu-lyon.fr   
Principal Investigator: Gilles RODE, Pr         
Sub-Investigator: Sophie COURTOIS, Dr         
Chu Nancy Recruiting
Nancy, France, 54035
Contact: Jean Paysant, Pr         
Principal Investigator: Jean Paysan, Pr         
Centre Mutualiste Rééducation et de Réadaptation Fonctionnelle de Kerpape LORIENT Recruiting
Ploemer, France, 56275
Contact: Jean-Luc LE GUIET, Pr       jlleguiet@kerpape.mutualite56.fr   
Principal Investigator: Jean-Luc LE GUIET, Pr         
Sub-Investigator: Pauline COIGNARD, Dr         
Chu Rennes Recruiting
Rennes, France, 35000
Contact: Isabelle BONAN, Dr       sabelle.bonan@chu-rennes.fr   
Principal Investigator: Isabelle BONAN, Dr         
Chu Saint-Etienne Not yet recruiting
Saint-etienne, France, 42055
Contact: Pascal GIRAUX, Pr       giraux.pascal@chu-st-etienne.fr   
Principal Investigator: Pascal GIRAUX, Pr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Geneviève CHENE, Pr University Hospital, Bordeaux
Principal Investigator: Pierre-Alain JOSEPH, Pr University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01365858     History of Changes
Other Study ID Numbers: CHUBX 2009/25
Study First Received: May 30, 2011
Last Updated: May 9, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 30, 2014