VET Evaluation: Healthy (VET_Healthy)

September 30, 2024 updated by: Francesca Cecchi, Fondazione Don Carlo Gnocchi Onlus

Experimental Evaluation of the Virtual Eggs Test on Healthy Participants

The study involving healthy participants aims to validate the Virtual Eggs Test (VET) as a tool for measuring hand dexterity and grip force control. This part of the study focuses on determining the test's reliability and validity in a population without motor impairments. Healthy participants will perform the VET using both their dominant and non-dominant hands across two sessions. The purpose is to establish baseline performance metrics for comparison with stroke patients and to assess the test's usability in clinical settings.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Italy
      • Florence, Italy, 50143
        • Fondazione Don Carlo Gnocchi Onlus

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 18 and 85 years.
  • No motor deficits.
  • Adequate cognitive and language abilities to understand the experiment and follow instructions.
  • Signed informed consent.

Exclusion Criteria:

  • Significant visual or oculomotor impairments.
  • Comorbidities or disabilities that may interfere with the study, such as multiple sclerosis, Parkinson's disease, or muscle tone disorders.
  • Cardiopulmonary or circulatory pathologies.
  • Pregnancy or breastfeeding.
  • Psychiatric comorbidities.
  • Difficulty understanding the Italian language.
  • Lack of cooperation.
  • Consumption of alcohol or diuretics before the test

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Hand Control Group (HHC Group)
The Healthy Hand Control Group (HHC Group) consists of participants without motor impairments, selected to establish baseline data for hand dexterity and grip strength using the Virtual Eggs Test (VET).
Other: Hand Dexterity Assessment
to evaluate the reliability and sensitivity of the VET in healthy. Their performance helps define normal thresholds and behaviors in grip force modulation and manual dexterity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Threshold from the Virtual Eggs Test (VET)
Time Frame: First Session (Test)
This refers to the grip strength threshold required to avoid breaking fragile objects during the test. The VET measures the participant's ability to regulate grip strength and dexterity, with the threshold ranging from 1 to 20. Lower numbers indicate that less force is needed to break the object, reflecting greater control over fine motor skills
First Session (Test)
Threshold from the Virtual Eggs Test (VET)
Time Frame: Second Session (Re-Test)
This refers to the grip strength threshold required to avoid breaking fragile objects during the test. The VET measures the participant's ability to regulate grip strength and dexterity, with the threshold ranging from 1 to 20. Lower numbers indicate that less force is needed to break the object, reflecting greater control over fine motor skills
Second Session (Re-Test)

Collaborators and Investigators

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

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

Scuola Superiore Sant'Anna di Pisa

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)

July 1, 2024

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • VirtualEggTest_Healthy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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