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Enrolling by invitation NCT06622473

Experimental Evaluation of the Virtual Eggs Test on Stroke Participants

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hand dexterity assessement.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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

Primary outcome measures

  • Threshold from the Virtual Eggs Test (VET) [Time frame: First Session (Test)]
  • Semmes-Weinstein Monofilament Test (SWMT) [Time frame: First Session (Test)]
  • Motricity Index (MI) [Time frame: First Sessione (Test)]
  • Nine Hole Peg Test (NHPT) [Time frame: First Session (Test)]
  • Abilhand-ULA [Time frame: First Session (Test)]
  • Threshold from the Virtual Eggs Test (VET) [Time frame: Second Session (Re-Test)]
Secondary outcome measures (2)
  • Feasibility of the VET in a clinical setting [Time frame: First Session (Test)]
  • Feasibility of the VET in a clinical setting [Time frame: Second Session (Re-Test)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Italy · 1 center
  • Fondazione Don Carlo Gnocchi ONLUS — Florence

Identifiers

NCT: NCT06622473 · VirtualEggTest_STROKE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗