Back to resultsEvaluation 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)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Activity of everyday life
Sponsored by
About this trial
This is an interventional other trial for Stroke
Eligibility Criteria
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
Sites / Locations
- CHU de Rennes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with stroke
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Evaluation of the patient's self-esteem
Evaluation of the patient's self-esteem by Rosenberg Self Estimate Scale
Full Information
NCT ID
NCT03274843
First Posted
September 4, 2017
Last Updated
June 9, 2021
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03274843
Brief 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
Acronym
EVIC-AVC
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 2, 2016 (Actual)
Primary Completion Date
November 9, 2016 (Actual)
Study Completion Date
November 9, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with stroke
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Activity of everyday life
Intervention Description
Kitchen workshop
Primary Outcome Measure Information:
Title
Change from baseline level of independence in a population of adult patients with stroke having participated in cooking workshop at week 3
Description
Evaluation of independence by Functional Independence Measure score
Time Frame
Day 0, Week 3
Secondary Outcome Measure Information:
Title
Evaluation of the patient's quality of life
Description
Evaluation of the patient's quality of life by the Medical Outcome Study (MOS)Short Form (SF-36 ) questionnaire
Time Frame
Day 0, Week 3
Title
Evaluation of the patient's self-esteem
Description
Evaluation of the patient's self-esteem by Rosenberg Self Estimate Scale
Time Frame
Day 0, Week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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