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Completed

NCT Number: NCT06476262

Occupational Gaps After Mild Stroke: a Single-Center Observational Study

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?

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Occupational Problems Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Les Trois Soleils

Boissise-le-Roi, 77310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

This research has only one arm. The intervention focuses on occupational issue

Behavioral

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

Primary outcomes

  1. Occupational Gaps Questionnaire

    Time frame: the OGQ was administred at the inclusion

    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.

Secondary outcomes

  1. Hospital Anxiety and Depression scale

    Time frame: HADS was asministred at the inclusion

    The Hospital Anxiety and Depression Scale (HADS) is a questionnaire widely used for detecting anxiety and depressive disorders.HADS comprises 14 items, seven of which relate to anxiety symptoms and seven to depressive symptoms. Each item is coded from 0 to 3. The scores for anxiety and depression can therefore vary from 0 to 21, depending on the presence and severity of the symptoms

  2. Montreal Cognitive Assessment

    Time frame: MoCA was administred at the inclusion

    The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for the detection of mild cognitive impairment. The MoCA assesses the following cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.

  3. Stroke Impact Scale

    Time frame: The SIS was administred at the inclusion

    The Stroke Impact Scale (SIS) is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional stroke outcomes, including strength, hand function Activities of Daily Living / Instrumental Activities of Daily Living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation.

  4. modified Ranking Scale

    Time frame: The mRS was administred at the inclusion

    The Modified Rankin Scale (MRS) is a single item, global outcomes rating scale for patients post-stroke. It is used to categorize level of functional independence with reference to pre-stroke activities rather than on observed performance of a specific task.

  5. Fatigue Severity Scale

    Time frame: The FSS was administred at the inclusion

    The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.

Sponsors and collaborators

Lead sponsor

Grosmaire

Other

Collaborators

  • Centre Hospitalier Sud Francilien

Registry information

Official study title

Investigating Occupational Gaps After Mild Stroke: Prevalence, Explanatory Factors, and Impact on Quality of Life in a Single-Center Study

Acronym: POPPAL

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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