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

Status

Completed

Conditions

Intervention / Treatment

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.

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

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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