StrokeNCT07497464
Validity of an Open-access Handedness Recognition Task in Stroke Patients
An observational study of Stroke, run by Alfredo Lerín Calvo at 1 site in Spain.
Trial summary
This study aims to assess the validity of a hand laterality discrimination task in patients who have suffered a stroke. The protocol involves two assessment sessions consisting of a Single Reaction Time (SRT) task and a Hand Laterality Judgement Task (HLJT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 7 Oct 2025to May 2027
- 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 study population consists of adult stroke survivors who have experienced a cerebrovascular accident. To ensure participants can understand the task instructions and provide reliable data, a cognitive screening is performed. Only individuals with a Montreal Cognitive Assessment (MoCA) score of greater than 21 ($MoCA > 21$) are included, thereby excluding patients with severe cognitive impairment that could interfere with the mental rotation and imagery tasks
Who may be able to join
- Adults (>18 years old) with Stroke
- MoCA score > 21 points
Who cannot join
- Other neurological conditions
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Neuron Clinics
Madrid, Madrid
Alejandro Herrera Rojas, Physical Therapist, +34 640944777, alejandro.herrera@lasallecampus.es
About this study
This study aims to assess the validity of a hand laterality discrimination task in patients who have suffered a stroke. The protocol involves two assessment sessions consisting of a Single Reaction Time (SRT) task and a Hand Laterality Judgement Task (HLJT). In the HLJT, participants are presented with images of right or left hands at various degrees of rotation and must determine the laterality of each hand. Primary outcomes include reaction time for the SRT, and both accuracy (percentage of correct responses) and decision-making time for the HLJT. Additionally, motor and kinesthetic imagery scales, as well as demographic and cognitive variables, are recorded.
Read the detailed description
The primary objective of this research is to evaluate the psychometric properties and validity of a hand laterality discrimination task in a post-stroke population. The study design includes two identical measurement points to assess the reliability and accuracy of motor processing.
The experimental protocol is divided into two main components:
Single Reaction Time (SRT) Task: This task is used to establish a motor processing baseline by measuring the simple reaction time to a stimulus.
Hand Laterality Judgement Task (HLJT): A mental rotation task where patients are shown photographs of right and left hands at different angles of rotation. Participants must decide whether the hand shown is a right or a left hand. The variables analyzed are the accuracy rate (percentage of correct responses) and the decision-making time (latency).
Upon completion of the HLJT, a structured interview is conducted to identify the mental strategies used during the task. This allows researchers to determine whether patients relied on motor imagery (e.g., mentally moving their own hand) or external visual strategies to achieve the results.
To complement these data, the study incorporates validated motor and kinesthetic imagery scales to assess the subjective quality of movement representation. Furthermore, demographic data (such as age and time since stroke) and cognitive variables are collected to control for potential confounding factors that may influence performance on the laterality tasks.
To evaluate the changes and the validity of the measurements, an Analysis of Covariance (ANCOVA) will be performed. In this model, the baseline measurement (Session 1) will be included as a covariate to control for initial individual differences in reaction time and accuracy. This approach allows for a more precise estimation of the task's stability and the effect of the variables studied by reducing the error variance associated with the participants' starting scores.
- Conditions
- Stroke
- Keywords
- Hand laterality judgement task, Tool validation, Laterality judgement, Stroke patients laterality judgement ability
- Medical subject headings
- Stroke
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 |
|---|---|---|
| Stroke group | This is a single-group study involving a cohort of stroke patients. All participants will undergo the same assessment protocol, including the Single Reaction Time (SRT) task, the Hand Laterality Judgement Task (HLJT) with post-task strategy interviews, and the administration of motor imagery, demographic, and cognitive scales. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Laterality Judgement
Ability to disclosure right/left hand laterality
Measured: At baseline + a follow-up 1 week later
Single Reaction Time Task
Measured: At baseline + a follow-up 1 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start7 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alfredo Lerín Calvo
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor-investigator, Alfredo Lerín Calvo, Neuron, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497464
- Sponsor's protocol ID
- NeuronClinic
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All used databases (anonymized data) will be uploaded to zenodo
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of an Open-access Handedness Recognition Task in Stroke Patients
- ClinicalTrials.gov ID
- NCT07497464
- Acronym / sponsor ID
- NeuronClinic
- Conditions
- Stroke
- Keywords
- Hand laterality judgement task, Tool validation, Laterality judgement, Stroke patients laterality judgement ability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alfredo Lerín CalvoUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Mar 2026 (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.
This study aims to assess the validity of a hand laterality discrimination task in patients who have suffered a stroke. The protocol involves two assessment sessions consisting of a Single Reaction Time (SRT) task and a Hand Laterality Judgement Task (HLJT). In the HLJT, participants are presented with images of right or left hands at various degrees of rotation and must determine the laterality of each hand. Primary outcomes include reaction time for the SRT, and both accuracy (percentage of correct responses) and decision-making time for the HLJT. Additionally, motor and kinesthetic imagery scales, as well as demographic and cognitive variables, are recorded.
Detailed description
The primary objective of this research is to evaluate the psychometric properties and validity of a hand laterality discrimination task in a post-stroke population. The study design includes two identical measurement points to assess the reliability and accuracy of motor processing.
The experimental protocol is divided into two main components:
Single Reaction Time (SRT) Task: This task is used to establish a motor processing baseline by measuring the simple reaction time to a stimulus.
Hand Laterality Judgement Task (HLJT): A mental rotation task where patients are shown photographs of right and left hands at different angles of rotation. Participants must decide whether the hand shown is a right or a left hand. The variables analyzed are the accuracy rate (percentage of correct responses) and the decision-making time (latency).
Upon completion of the HLJT, a structured interview is conducted to identify the mental strategies used during the task. This allows researchers to determine whether patients relied on motor imagery (e.g., mentally moving their own hand) or external visual strategies to achieve the results.
To complement these data, the study incorporates validated motor and kinesthetic imagery scales to assess the subjective quality of movement representation. Furthermore, demographic data (such as age and time since stroke) and cognitive variables are collected to control for potential confounding factors that may influence performance on the laterality tasks.
To evaluate the changes and the validity of the measurements, an Analysis of Covariance (ANCOVA) will be performed. In this model, the baseline measurement (Session 1) will be included as a covariate to control for initial individual differences in reaction time and accuracy. This approach allows for a more precise estimation of the task's stability and the effect of the variables studied by reducing the error variance associated with the participants' starting scores.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke group | – | –This is a single-group study involving a cohort of stroke patients. All participants will undergo the same assessment protocol, including the Single Reaction Time (SRT) task, the Hand Laterality Judgement Task (HLJT) with post-task strategy interviews, and the administration of motor imagery, demographic, and cognitive scales. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult stroke survivors who have experienced a cerebrovascular accident. To ensure participants can understand the task instructions and provide reliable data, a cognitive screening is performed. Only individuals with a Montreal Cognitive Assessment (MoCA) score of greater than 21 ($MoCA > 21$) are included, thereby excluding patients with severe cognitive impairment that could interfere with the mental rotation and imagery tasks
Key inclusion criteria (2 listed)
- Adults (>18 years old) with Stroke
- MoCA score > 21 points
Key exclusion criteria (2 listed)
- Other neurological conditions
- Severe cognitive impairment
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
Hand Laterality Judgement
Time frame: At baseline + a follow-up 1 week later
Ability to disclosure right/left hand laterality
Single Reaction Time Task
Time frame: At baseline + a follow-up 1 week later
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 27 Mar 2026.
- Individual participant dataSharing planned: Yes. All used databases (anonymized data) will be uploaded to zenodo
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Alfredo Lerín Calvo at 1 site in Spain.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Marcos Moreno Verdú, Physical Therapist (+34 630 01 29 25, marcos.morenoverdu@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Laterality Judgement (time frame: At baseline + a follow-up 1 week later). The study lists 2 primary outcomes in all. 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 27 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.