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

Completed

• Conditions: Occupational Problems; Stroke

• Registration Number: NCT06476262
• Lead Sponsor: Grosmaire

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-13
• Primary Completion: 2023-05-11
• Study Completion: 2023-06-26
• Status Verified: 2024-06
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occupational Gaps Questionnaire	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 Outcome Measures

Name	Time	Method
Fatigue Severity Scale	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.
modified Ranking Scale	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.
Hospital Anxiety and Depression scale	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
Stroke Impact Scale	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.
Montreal Cognitive Assessment	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.

Trial Locations

Locations (1)

Clinique Les Trois Soleils; 🇫🇷 Boissise-le-Roi, France