NCT03274843

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

September 4, 2017

Last Update Submit

June 9, 2021

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 0, Week 3

Secondary Outcomes (2)

  • Evaluation of the patient's quality of life

    Day 0, Week 3

  • Evaluation of the patient's self-esteem

    Day 0, Week 3

Study Arms (1)

Patient with stroke

EXPERIMENTAL
Other: Activity of everyday life

Interventions

Activity of everyday lifeOTHER

Kitchen workshop

Patient with stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 7, 2017

Study Start

March 2, 2016

Primary Completion

November 9, 2016

Study Completion

November 9, 2016

Last Updated

June 10, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)