Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06622473

Experimental Evaluation of the Virtual Eggs Test on Stroke Participants

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Don Carlo Gnocchi ONLUS

Florence, 50143, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

hand dexterity assessement

Device

Each participant will perform the VET, with their most affected hand, followed by the VET with the less affected hand.

Primary outcomes

  1. 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.

  2. Semmes-Weinstein Monofilament Test (SWMT)

    Time frame: First Session (Test)

    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.

  3. Motricity Index (MI)

    Time frame: First Sessione (Test)

    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.

  4. Nine Hole Peg Test (NHPT)

    Time frame: First Session (Test)

    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.

  5. Abilhand-ULA

    Time frame: First Session (Test)

    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.

  6. 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.

Secondary outcomes

  1. Feasibility of the VET in a clinical setting

    Time frame: First Session (Test)

    Measurement of the average test duration in minutes

  2. Feasibility of the VET in a clinical setting

    Time frame: Second Session (Re-Test)

    Measurement of the average test duration in minutes

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • Scuola Superiore Sant'Anna di Pisa

Registry information

Acronym: VET_STROKE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.