NCT06476262

Brief Summary

The goal of this observational study is to investigate participation restrictions and their determinants in people after a mild stroke. The main questions it aims to answer are: Do mRS score, time since stroke onset, cognitive disorders, mood disorders and fatigue negatively impact occupations after mild stroke? Does an increased prevalence of occupational gaps correlate with a diminished quality of life following mild stroke?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

June 21, 2024

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occupational Gaps Questionnaire

    The Occupational Gaps Questionnaire (OGQ) assesses presence of occupational gaps in 28 activities, i.e. instrumental ADL, social- leisure- and work/work related activities. Two studies are published on occupational gaps. An occupational gap is defined as the gap that occurs between what an individual wants and needs to do and what he/she actually does.

    the OGQ was administred at the inclusion

Secondary Outcomes (5)

  • Hospital Anxiety and Depression scale

    HADS was asministred at the inclusion

  • Montreal Cognitive Assessment

    MoCA was administred at the inclusion

  • Stroke Impact Scale

    The SIS was administred at the inclusion

  • modified Ranking Scale

    The mRS was administred at the inclusion

  • Fatigue Severity Scale

    The FSS was administred at the inclusion

Interventions

During the post-stroke consultation, each participant is invited to complete questionnaires on occupational gaps, mood disorders, fatigue, cognition, and quality of life.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population was selected from the active file of stroke patients undergoing post-stroke consultation at the Centre Hospitalier Sud Francilien.

You may qualify if:

  • over 18 years old,
  • a diagnosis of stroke confirmed by cerebral imaging,
  • an mRS score \<3 at the post-stroke consultation,
  • informed about the study
  • not opposed to participation

You may not qualify if:

  • cognitive dysfunction making participation in the study impossible,
  • phasic disorders preventing comprehension of the questionnaires,
  • neurological deficits prior to the stroke, a history of psychiatric disorders
  • being under legal protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Les Trois Soleils

Boissise-le-Roi, 77310, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christophe T Duret, MD

    Clinique Les Trois Soleils

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
OT, CRA

Study Record Dates

First Submitted

June 21, 2024

First Posted

June 26, 2024

Study Start

February 13, 2023

Primary Completion

May 11, 2023

Study Completion

June 26, 2023

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations