Study of the Participation of People With Aphasia Post Stroke and Their Caregivers in Valladolid Region (Spain)

NCT06948721 | Not Yet Recruiting

• 1 other identifier: CIRON
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to determine the level of community participation of people with post-stroke aphasia and their caregivers, as well as the factors that facilitate or interfere with this participation in the Valladolid region (Spain). The main questions that this study aims to answer are:

1. 1.What is the retained activities of the people with aphasia post-stroke?
2. 2.What is the retained activities of the caregivers of people with aphasia post-stroke?
3. 3.What factors influence the community participation of people with aphasia post-stroke and their caregivers?

Conditions

Stroke; Aphasia

Keywords

Aphasia post stroke; caregiver; community participation; occupational therapy; Speech Language Therapy

Outcome Measures

Primary Outcomes (1)

• Activity Card Sort

  The Activity Card Sort will determine the level of participation maintained by people with aphasia and their caregivers at the time of the assessment. It will provide data on overall participation, as well as participation in leisure, social, educational, and work activities. The Activity Card Sort scale scores range from 0 to 100%. Higher percentages, better.

  Baseline

Secondary Outcomes (6)

• The Western Aphasia Battery (WAB)

  Baseline

• Barthel Index (BI)

  Baseline

• Zarit Caregiver Burden Interview (ZBI)

  Baseline

• Six-Minute Walk Test (6MWT)

  Baseline

• Ten-Meter Walk Test (10MWT)

  Baseline.

Study Arms (2)

people with aphasia post stroke

Caregivers of people with aphasia post stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants in the study (people with aphasia and their caregivers) will be drawn from the registry of people treated at the companies CIRONBRAIN and CIRONLAB, which comprise the research team. Sample recruitment will also be conducted through CIRONBRAIN's social media channels, and through requests for collaboration with local disability organizations and healthcare professionals in the Valladolid region who are familiar with the project and who may be eligible for selection.

You may qualify if:

• Chronic Stroke (stroke onset above six months).
• Aphasia post stroke.
• Residents in Valladolid Region.
• Age over 18 years.
• Ability to walk equal to or greater than 3 according to the Functional Ambulation Category (FAC).
• Informed consent acceptance.

You may not qualify if:

• Stroke onset below of Six months
• Age under 18 years
• Both in the case of the person with aphasia and their caregiver, presence of other pathologies that affect functional independence

Sponsors & Collaborators

• Centro Integral de Rehabilitación: lead

MeSH Terms

Conditions

Stroke; Aphasia; Communication Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Jorge Alegre-Ayala, Ph.D OTR

CONTACT

+34680274889; jalegreayala@cironrehabilitacion.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 29, 2025
• Study Start: May 6, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share