NCT01365858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2011

Typical duration for not_applicable stroke

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 14, 2026

Status Verified

November 1, 2014

Enrollment Period

2.8 years

First QC Date

May 30, 2011

Last Update Submit

May 11, 2026

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Ability to perform shopping test in real supermarket (all items collected and all actions needed done)

    After rehabilitation (day 16)

Secondary Outcomes (1)

  • 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

Study Arms (2)

Virtual reality-based cognitive training

EXPERIMENTAL
Other: Rehabilitation

Cognitive rehabilitation (without extra computer training)

ACTIVE COMPARATOR
Other: Rehabilitation

Interventions

RehabilitationOTHER

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)Virtual reality-based cognitive training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults
  • 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

You may not qualify if:

  • dementia or severe psychiatric disease
  • epilepsy
  • disorder of consciousness
  • visual agnosia
  • severe visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU Bordeaux

Bordeaux, 33000, France

Location

Ap-Hp Garches

Garches, 92380, France

Location

Hospices Civils de Lyon

Lyon, 69424, France

Location

Chu Nancy

Nancy, 54035, France

Location

Centre Mutualiste Rééducation et de Réadaptation Fonctionnelle de Kerpape LORIENT

Ploemeur, 56275, France

Location

Chu Rennes

Rennes, 35000, France

Location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (2)

  • Cogne M, Knebel JF, Klinger E, Bindschaedler C, Rapin PA, Joseph PA, Clarke S. The effect of contextual auditory stimuli on virtual spatial navigation in patients with focal hemispheric lesions. Neuropsychol Rehabil. 2018 Jan;28(1):1-16. doi: 10.1080/09602011.2015.1127260. Epub 2016 Jan 6.

    PMID: 27653552RESULT

  • Cogne M, Violleau MH, Klinger E, Joseph PA. Influence of non-contextual auditory stimuli on navigation in a virtual reality context involving executive functions among patients after stroke. Ann Phys Rehabil Med. 2018 Nov;61(6):372-379. doi: 10.1016/j.rehab.2018.01.002. Epub 2018 Jan 31.

    PMID: 29407275RESULT

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Geneviève CHENE, Pr

    University Hospital, Bordeaux

    STUDY CHAIR

  • Pierre-Alain JOSEPH, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2011

First Posted

June 3, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

May 14, 2026

Record last verified: 2014-11

Locations

FR(7)