- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07497464
Validity of an Open-access Handedness Recognition Task in Stroke Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marcos Moreno Verdú, Physical Therapist
- Phone Number: +34 630 01 29 25
- Email: marcos.morenoverdu@uclouvain.be
Study Contact Backup
- Name: Alfredo Lerín Calvo, Physical Therapist
- Phone Number: +34 620187457
- Email: alerin@neuronrehab.es
Study Locations
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Madrid
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Madrid, Madrid, Spain
- Recruiting
- Neuron Clinics
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Contact:
- Alejandro Herrera Rojas, Physical Therapist
- Phone Number: +34 640944777
- Email: alejandro.herrera@lasallecampus.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults (>18 years old) with Stroke
- MoCA score > 21 points
Exclusion Criteria:
- Other neurological conditions
- Severe cognitive impairment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Laterality Judgement
Time Frame: At baseline + a follow-up 1 week later
|
Ability to disclosure right/left hand laterality
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At baseline + a follow-up 1 week later
|
|
Single Reaction Time Task
Time Frame: At baseline + a follow-up 1 week later
|
At baseline + a follow-up 1 week later
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NeuronClinic
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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