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Virtual Action Planning in Stroke: a Control Rehabilitation Study

NCT ID: NCT01365858

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-02-28

Brief Summary

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* 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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Virtual reality-based cognitive training

Group Type EXPERIMENTAL

Rehabilitation

Intervention Type OTHER

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).

Cognitive rehabilitation (without extra computer training)

Group Type ACTIVE_COMPARATOR

Rehabilitation

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geneviève CHENE, Pr

Role: STUDY_CHAIR

University Hospital, Bordeaux

Pierre-Alain JOSEPH, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status

Ap-Hp Garches

Garches, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

Chu Nancy

Nancy, , France

Site Status

Centre Mutualiste Rééducation et de Réadaptation Fonctionnelle de Kerpape LORIENT

Ploemeur, , France

Site Status

Chu Rennes

Rennes, , France

Site Status

Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2009/25

Identifier Type: -

Identifier Source: org_study_id