StrokeVAPS REHABNCT01365858
Virtual Action Planning in Stroke: a Control Rehabilitation Study
A study testing Rehabilitation in people with Stroke, run by University Hospital, Bordeaux at 7 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 7 sitesFrance
- Study dates
- May 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- dementia or severe psychiatric disease
- epilepsy
- disorder of consciousness
- visual agnosia
- severe visual impairment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Bordeaux
Bordeaux, 33000
Ap-Hp Garches
Garches, 92380
Hospices Civils de Lyon
Lyon, 69424
Chu Nancy
Nancy, 54035
Centre Mutualiste Rééducation et de Réadaptation Fonctionnelle de Kerpape LORIENT
Ploemeur, 56275
Chu Rennes
Rennes, 35000
Chu Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Effectiveness of Virtual Reality-based Cognitive Training in Daily Living in Stroke Patients Using Virtual Action Planning Supermarket (VAP-S)
- 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality-based cognitive training | Experimental | Not described Receives: Other: Rehabilitation |
| Cognitive rehabilitation (without extra computer training) | Active comparator | Not described Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to perform shopping test in real supermarket (all items collected and all actions needed done)
Measured: 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.
Measured: Before (day 1) and after (day16) rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geneviève CHENE, Pr, Study chair, University Hospital, BordeauxPierre-Alain JOSEPH, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365858
- Sponsor's protocol ID
- CHUBX 2009/25
- Other IDs
- 2009-A00742-55
- Acronym
- VAPS REHAB
- Status last verified
- Nov 2014
- First submitted
- 30 May 2011
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27653552Cogne 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.
PubMed 29407275
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality-based Cognitive Training in Daily Living in Stroke Patients Using Virtual Action Planning Supermarket (VAP-S)
- ClinicalTrials.gov ID
- NCT01365858
- Acronym / sponsor ID
- VAPS REHAB / CHUBX 2009/25
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality-based cognitive training | Experimental | Other: Rehabilitation |
| Cognitive rehabilitation (without extra computer training) | Active comparator | Other: Rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- dementia or severe psychiatric disease
- epilepsy
- disorder of consciousness
- visual agnosia
- severe visual impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationThe 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). | Other | Cognitive rehabilitation (without extra computer training), Virtual reality-based cognitive training |
Primary outcome
Ability to perform shopping test in real supermarket (all items collected and all actions needed done)
Time frame: After rehabilitation (day 16)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 27653552Cogne 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.
- Results publication: PubMed 29407275Cogne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geneviève CHENE, Pr study chair
University Hospital, Bordeaux
Pierre-Alain JOSEPH, Pr principal investigator
University Hospital, Bordeaux
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Stroke, run by University Hospital, Bordeaux at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to perform shopping test in real supermarket (all items collected and all actions needed done) (time frame: After rehabilitation (day 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01365858, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.