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

Don Carlo Gnocchi Onlus Foundation

Status: Invitation-only

Conditions: Stroke

Treatments: Device: hand dexterity assessement

Study type: Interventional

Funder types: Other

Identifiers

NCT06622473

VirtualEggTest_STROKE

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Stroke group

Experimental group

Description:

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.

Treatment:

Device: hand dexterity assessement