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NCT Number: NCT06948721

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Activity Card Sort

    Time frame: Baseline

    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.

Secondary outcomes

  1. The Western Aphasia Battery (WAB)

    Time frame: Baseline

    The Western Aphasia Battery (WAB) is a tool used to assess the linguistic skills (information content, fluency, auditory comprehension, repetition, naming and word finding, reading, and writing) and nonlinguistic skills (drawing, block design, calculation, and praxis) of adults with aphasia. This provides information for the diagnosis of the type of aphasia. The Western Aphasia Battery uses an Aphasia Quotient (AQ) to assess the severity of aphasia, with scores ranging from 0 to 100. Higher score, less severity of aphasia.

  2. Barthel Index (BI)

    Time frame: Baseline

    The BI assesses the level of functional independence in basic activities of daily living (eating, hygiene, dressing, mobility, etc.). Barthel index scores range from 0 to 100 points. Higher scores, better.

  3. Zarit Caregiver Burden Interview (ZBI)

    Time frame: Baseline

    The aim of the Zarit Caregiver Burden Interview (ZBI) is to assess the perceived burden experienced by caregivers, particularly in terms of the physical, emotional, social, and financial impacts of caregiving. The Zarit Caregiver Burden Interview scale scores range from 22 to 110 points. Higher scores indicate worse outcomes.

  4. Six-Minute Walk Test (6MWT)

    Time frame: Baseline

    The Six-Minute Walk test aims to assess a person's functional exercise capacity by measuring the distance they can walk in six minutes on a flat surface. Higher score, better.

  5. Ten-Meter Walk Test (10MWT)

    Time frame: Baseline.

    The Ten-Meter Walk Test evaluates walking speed over a short distance (10 meters). This scale provides data on normal speed and fast speed. Higher speed, better.

  6. Hospital Anxiety and Depression Scale

    Time frame: Baseline

    The purpose of the Hospital Anxiety and Depression Scale is identify depression and anxiety among physically ill patients, through a brief questionnaire which involves both dimensions. The scoring of the Hospital Anxiety and Depression Scale 0-21 for each subscale, with higher scores indicating greater anxiety or depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Jorge Alegre-Ayala, Ph.D OTR

CONTACT

[email protected]

+34680274889

Sponsors and collaborators

Lead sponsor

Centro Integral de Rehabilitación

Other

Registry information

Acronym: SPART-A

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2025
Registry last updated
May 2, 2025

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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