NCT06622460

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 26, 2024

Last Update Submit

September 30, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Threshold from the Virtual Eggs Test (VET)

    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)

    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)

Study Arms (1)

Healthy Hand Control Group (HHC Group)

EXPERIMENTAL

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

Interventions

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.

Healthy Hand Control Group (HHC Group)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Don Carlo Gnocchi ONLUS

Florence, Florence, 50143, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 2, 2024

Study Start

July 1, 2024

Primary Completion

November 15, 2024

Study Completion

January 15, 2025

Last Updated

October 2, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations