StrokeSPART-ANCT06948721
Study of the Participation of People With Aphasia Post Stroke and Their Caregivers in Valladolid Region (Spain)
An observational study of Stroke and Aphasia, run by Centro Integral de Rehabilitación.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2025to 20 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
- What is the retained activities of the people with aphasia post-stroke?
- What is the retained activities of the caregivers of people with aphasia post-stroke?
- What factors influence the community participation of people with aphasia post-stroke and their caregivers?
- Keywords
- Aphasia post stroke, caregiver, community participation, occupational therapy, Speech Language Therapy
- Medical subject headings
- Stroke, Aphasia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| people with aphasia post stroke | Not described | |
| Caregivers of people with aphasia post stroke | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (6)
The Western Aphasia Battery (WAB)
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.
Measured: Baseline
Barthel Index (BI)
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.
Measured: Baseline
Zarit Caregiver Burden Interview (ZBI)
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.
Measured: Baseline
Six-Minute Walk Test (6MWT)
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.
Measured: Baseline
Ten-Meter Walk Test (10MWT)
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.
Measured: Baseline.
Hospital Anxiety and Depression Scale
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start6 May 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Integral de Rehabilitación
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Alegre Ayala, Centro Integral de Rehabilitación
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948721
- Sponsor's protocol ID
- CIRON
- Acronym
- SPART-A
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Participation of People With Aphasia Post Stroke and Their Caregivers in Valladolid Region (Spain)
- ClinicalTrials.gov ID
- NCT06948721
- Acronym / sponsor ID
- SPART-A / CIRON
- Keywords
- Aphasia post stroke, caregiver, community participation, occupational therapy, Speech Language Therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centro Integral de RehabilitaciónUniversity, hospital or other
- Study start
- 6 May 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the retained activities of the people with aphasia post-stroke?
- What is the retained activities of the caregivers of people with aphasia post-stroke?
- What factors influence the community participation of people with aphasia post-stroke and their caregivers?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| people with aphasia post stroke | – | – |
| Caregivers of people with aphasia post stroke | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
The Western Aphasia Battery (WAB)
Time frame: Baseline
Barthel Index (BI)
Time frame: Baseline
Zarit Caregiver Burden Interview (ZBI)
Time frame: Baseline
Six-Minute Walk Test (6MWT)
Time frame: Baseline
Ten-Meter Walk Test (10MWT)
Time frame: Baseline.
Hospital Anxiety and Depression Scale
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Aphasia, run by Centro Integral de Rehabilitación.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Alegre-Ayala, Ph.D OTR (+34680274889, jalegreayala@cironrehabilitacion.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity Card Sort (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.