Experimental Evaluation of the Virtual Eggs Test on Stroke Participants (VET_STROKE)

The study protocol focuses on evaluating the Virtual Eggs Test (VET) as a tool for assessing hand dexterity and grip strength control in post-stroke patients. The study aims to validate the reliability and concurrent validity of the VET, comparing its outcomes with established tests like the Nine Hole Peg Test (NHPT), the Motricity Index, the Semmes-Weinstein Monofilament Test (SWMT), and the Abilhand-ULA questionnaire

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke
• Intervention / Treatment: Device: hand dexterity assessement

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: Participants of both sexes and any ethnicity, aged 18 to 85 years.

• Post-stroke patients:

  • Participants who have experienced a first ischemic or hemorrhagic stroke.
  • Participants must be in the sub-acute phase (between 2 weeks and 6 months after the stroke) or the chronic phase (more than 6 months after the stroke).
  • Sufficient motor capabilities to perform motor tasks.
• Cognitive and language capabilities: Participants must have sufficient cognitive and language abilities to understand the experiment and follow instructions.
• Informed consent: Participants must provide signed informed consent after being fully informed about the study.

Exclusion Criteria:

• Visual or oculomotor impairments: Participants with significant visual or eye movement disorders.

• Comorbidities/disabilities:

  • Participants with conditions such as multiple sclerosis, Parkinson's disease, muscle tone disorders, or malignant neoplasms, which may interfere with the ability to understand or perform the protocol.
  • Cardiopulmonary or circulatory pathologies.
• Pregnancy or breastfeeding.
• Psychiatric comorbidities.
• Language barriers: Participants unable to adequately understand the Italian language.
• Lack of collaboration: Participants who cannot cooperate sufficiently with the study requirements.
• Substance use: Consumption of alcohol or diuretics before the tests.

• Motor function criteria:

  • Participants with a Motricity Index score of <19 for the pinch grip item.
  • A total upper limb Motricity Index score of <57.
  • Participants with a fixed contracture of the affected limb (Modified Ashworth Scale = 4).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke group; each participant will perform the VET, NHPT, Abilhand-ULA, and Motricity Index with their most affected hand, followed by the VET and NHPT with the less affected hand.	Device: hand dexterity assessement; Each participant will perform the VET, with their most affected hand, followed by the VET with the less affected hand.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Semmes-Weinstein Monofilament Test (SWMT)	A test that measures tactile sensitivity by applying calibrated filaments to the skin. The pressure exerted by the filaments ranges from 0.07 to 300 grams, with lower values indicating greater sensitivity and higher values indicating reduced sensation. The range helps to detect sensory deficits in the hands post-stroke.	First Session (Test)
Motricity Index (MI)	A clinical assessment used to evaluate strength in the upper limb. It involves scoring the patient's ability to perform specific movements on a scale from 0 to 100, where 0 indicates no movement and 100 represents normal strength. Scores between 57 to 100 suggest varying degrees of strength in the upper limb.	First Sessione (Test)
Nine Hole Peg Test (NHPT)	A timed test that assesses manual dexterity. The participant is asked to place and remove nine pegs from holes as quickly as possible. The total time is recorded, typically ranging from 20 to 60 seconds depending on the severity of impairment. Lower times indicate better dexterity.	First Session (Test)
Abilhand-ULA	A self-assessment questionnaire used to measure manual ability in daily activities for individuals with upper limb impairments. Scores range from 0 to 2 for each item, where 0 means the task is impossible, 1 means it is difficult, and 2 means the task can be performed easily.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the VET in a clinical setting	Measurement of the average test duration in minutes	First Session (Test)
Feasibility of the VET in a clinical setting	Measurement of the average test duration in minutes	Second Session (Re-Test)

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: Scuola Superiore Sant'Anna di Pisa

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): February 20, 2025
• Study Completion (Estimated): April 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

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: VirtualEggTest_STROKE

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