Clinical trial NCT06622473: Experimental Evaluation of the Virtual Eggs Test on Stroke Participants
Official title: Experimental Evaluation of the Virtual Eggs Test on Stroke Participants
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Scuola Superiore Sant&#39;Anna di Pisa
First posted: 2024-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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


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

Primary outcomes:
measure: Threshold from the Virtual Eggs Test (VET)
timeFrame: First Session (Test)
measure: Semmes-Weinstein Monofilament Test (SWMT)
timeFrame: First Session (Test)
measure: Motricity Index (MI)
timeFrame: First Sessione (Test)
measure: Nine Hole Peg Test (NHPT)
timeFrame: First Session (Test)
measure: Abilhand-ULA
timeFrame: First Session (Test)
measure: Threshold from the Virtual Eggs Test (VET)
timeFrame: Second Session (Re-Test)
Secondary outcomes:
measure: Feasibility of the VET in a clinical setting
timeFrame: First Session (Test)
measure: Feasibility of the VET in a clinical setting
timeFrame: Second Session (Re-Test)
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Fondazione Don Carlo Gnocchi ONLUS
Study officials:
References: