- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03274843
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 (EVIC-AVC)
June 9, 2021 updated by: Rennes University Hospital
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 Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rennes, France, 35033
- CHU de Rennes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient with stroke
|
Kitchen workshop
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0, Week 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the patient's quality of life
Time Frame: Day 0, Week 3
|
Evaluation of the patient's quality of life by the Medical Outcome Study (MOS)Short Form (SF-36 ) questionnaire
|
Day 0, Week 3
|
Evaluation of the patient's self-esteem
Time Frame: Day 0, Week 3
|
Evaluation of the patient's self-esteem by Rosenberg Self Estimate Scale
|
Day 0, Week 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2016
Primary Completion (Actual)
November 9, 2016
Study Completion (Actual)
November 9, 2016
Study Registration Dates
First Submitted
September 4, 2017
First Submitted That Met QC Criteria
September 5, 2017
First Posted (Actual)
September 7, 2017
Study Record Updates
Last Update Posted (Actual)
June 10, 2021
Last Update Submitted That Met QC Criteria
June 9, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC15_3021_EVIC-AVC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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