Computational Assessment of Hand Motor Skills in Stroke Patients

August 2, 2022 updated by: Instituto de Investigación Hospital Universitario La Paz

This is a two phase prospective observational study that aims to validate the use of a motion capture software (Leap Motion) to measure and quantify functional deficits of the hand in stroke patients using a standard battery of exercises. The objectives of this study are:

  1. To compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.
  2. To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.
  3. To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.
  4. To analyze changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cases: 100 subjects with ischemic stroke with functional motor hand deficit Healthy subjects: 100 subjects matched by age with ischemic stroke patients.

Description

Inclusion Criteria:

  • Stroke patients: clinically stable, with hand functional deficit at the momment they consent to participate in the study. Signed consent to participate.
  • Healthy subjects: similar age to stroke patients, without previous clinical history of stroke or any disease that could affect hand motor skills. Signed consent to participate.

Exclusion Criteria:

  • Aphasia or cognitive impairment, confusional syndrome or other conditions that could prevent comprehension and acomplishment of the task.
  • Plegia or severe paresis of the hand that could prevent adecuate performance of the task.
  • Previous stroke.
  • Previous dependance.
  • Previous diagnosis of any other neurologic disease or condition that could affect hand motricity.
  • Life expectancy below three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy subjects
Device: Kinematic computational analysis of the hand (Leap Motion device)

Kinematic computational analysis exercises:

  1. Finger extension
  2. Wrist extension
  3. Finger separation
  4. Finger clamp
Ischemic stroke patients with functional deficit of the hand
Device: Kinematic computational analysis of the hand (Leap Motion device)

Kinematic computational analysis exercises:

  1. Finger extension
  2. Wrist extension
  3. Finger separation
  4. Finger clamp

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hand kinematic computational analysis
Time Frame: First month
o compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects.
First month
Relation between hand kinematic computational analysis and clinical scales
Time Frame: First month
To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients.
First month
Relation between hand kinematic computational analysis and stroke lesion on brain MRI.
Time Frame: First month
To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI.
First month
Results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.
Time Frame: 1 month and three months
Changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.
1 month and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación Hospital Universitario La Paz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Politecnica de Madrid
Hospital Universitario La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI-4776

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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