StrokeEVIC-AVCNCT03274843
Evaluation of the Improvement of Independence by the Resumption of a Significant Activity Such as a Cooking Workshop in Adult Patients With Stroke Benefiting From Traditional Rehabilitation
A study testing Activity of everyday life in people with Stroke, run by Rennes University Hospital at 1 site in France.
Trial summary
A non-randomized, monocentric, pilot study comparing the level of independence for each individual with significant resumption of activity in adult patients with stroke Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Activity of everyday life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2016to 9 Nov 2016
- 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
- Patient older than 18 years old
- Primary stroke or recurrence on stroke having no previous sequelae
- Stroke older than 3 weeks
- Ability to understand treatment and sufficient motivation
- Problem Activity Indicated in CMOP (Canadian Measure of Occupational Performance)
- Barthel Index > 60
- Patient who received oral and written information about the protocol and who did not show opposition to participate in the study
Who cannot join
- Dermatological pathology with wounds on the unhealed upper limbs
- Patient in contact and droplet isolation
- A psychiatric history requiring hospitalization in specialized settings for more than 2 months
- Any condition that may limit participation or interfere with analysis of results
Trial locations and contacts
1 site in 1 country.
About this study
A non-randomized, monocentric, pilot study comparing the level of independence for each individual with significant resumption of activity in adult patients with stroke
- Conditions
- Stroke
- Being tested
- Activity of everyday life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity of everyday lifeOther
Kitchen workshop
| Study group | Role | What they receive |
|---|---|---|
| Patient with stroke | Experimental | Not described Receives: Other: Activity of everyday life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline level of independence in a population of adult patients with stroke having participated in cooking workshop at week 3
Evaluation of independence by Functional Independence Measure score
Measured: Day 0, Week 3
Secondary outcomes (2)
Evaluation of the patient's quality of life
Evaluation of the patient's quality of life by the Medical Outcome Study (MOS)Short Form (SF-36 ) questionnaire
Measured: Day 0, Week 3
Evaluation of the patient's self-esteem
Evaluation of the patient's self-esteem by Rosenberg Self Estimate Scale
Measured: Day 0, Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start2 Mar 2016
- Primary completion9 Nov 2016
- Study completion9 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274843
- Sponsor's protocol ID
- 35RC15_3021_EVIC-AVC
- Acronym
- EVIC-AVC
- Status last verified
- Jun 2021
- First submitted
- 4 Sep 2017
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Improvement of Independence by the Resumption of a Significant Activity Such as a Cooking Workshop in Adult Patients With Stroke Benefiting From Traditional Rehabilitation
- ClinicalTrials.gov ID
- NCT03274843
- Acronym / sponsor ID
- EVIC-AVC / 35RC15_3021_EVIC-AVC
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 7 Sep 2017 (actual)
- 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.
A non-randomized, monocentric, pilot study comparing the level of independence for each individual with significant resumption of activity in adult patients with stroke
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with stroke | Experimental | Other: Activity of everyday life |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient older than 18 years old
- Primary stroke or recurrence on stroke having no previous sequelae
- Stroke older than 3 weeks
- Ability to understand treatment and sufficient motivation
- Problem Activity Indicated in CMOP (Canadian Measure of Occupational Performance)
Key exclusion criteria (4 listed)
- Dermatological pathology with wounds on the unhealed upper limbs
- Patient in contact and droplet isolation
- A psychiatric history requiring hospitalization in specialized settings for more than 2 months
- Any condition that may limit participation or interfere with analysis of results
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 |
|---|---|---|
| Activity of everyday lifeKitchen workshop | Other | Patient with stroke |
Primary outcome
Change from baseline level of independence in a population of adult patients with stroke having participated in cooking workshop at week 3
Time frame: Day 0, Week 3
Evaluation of independence by Functional Independence Measure score
2 secondary outcomes
Evaluation of the patient's quality of life
Time frame: Day 0, Week 3
Evaluation of the patient's self-esteem
Time frame: Day 0, Week 3
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 10 Jun 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity of everyday life in people with Stroke, run by Rennes University Hospital at 1 site 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 4 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from baseline level of independence in a population of adult patients with stroke having participated in cooking workshop at week 3 (time frame: Day 0, Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2021.