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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

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 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

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
Intervention / Treatment
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

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

Instituto de Investigación Hospital Universitario La Paz

Collaborators

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)

May 13, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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