Experimental Validation of the Virtual Eggs Test (VET) in Children and Young Adults With Cerebral Palsy and Developmental Coordination Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Score of Virtual Eggs Test (VET)
研究概览
简要总结
This study aims to investigate the validity of the Virtual Egg Test (VET) for the assessment of manual dexterity in children and adolescents with cerebral palsy and developmental coordination disorder (experimental group), including a typically developing group for the collection and establishment of normative values (control group).
The clinical site where the study procedures for the experimental group will be conducted is the IRCCS Fondazione Stella Maris in Calambrone (Pisa), Italy. Participants of both sexes and of any ethnicity, aged between 6 and 21 years at the time of recruitment, will be selected according to specific inclusion criteria.
The study protocol consists of two assessment sessions scheduled at an interval of at least 3 days and no more than 5 days.
During the first assessment session (T0), standardized and non-standardized assessment procedures will be administered. First, the Virtual Egg Test (VET) will be administered using the Virtual Egg (VE). The VE is a parallelepiped-shaped device equipped with an internal magnetic mechanism that maintains the walls of the object in a predefined, non-collapsed position. When the grip force exceeds the attractive force between the two magnets, the external walls move closer together, causing the "VE to break" reversibly.
The sensorized platform comprises three distinct sensitive areas: the starting position and two target areas for placing the VEs. The areas are separated by a 6-cm-high barrier.
Subsequently, standardized clinical assessment tests will be administered. During the second assessment session (T1), the Virtual Egg Test (VET) will be administered, followed by a feasibility questionnaire specifically developed for this study regarding its use. The questionnaire will be completed by both the participant and the clinical staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria - Cerebral Palsy Group
- •Diagnosis of Cerebral Palsy;
- •Participants of either sex and of any ethnicity, aged between 6 and 21 years at the time of recruitment;
- •MACS Level I-III (for participants with Cerebral Palsy);
- •BFMF Level I-IV (for participants with Cerebral Palsy);
- •House Functional Classification Level 4-8;
- •At least one cognitive index score >70 on the WISC-IV, WISC-V, or WAIS-IV;
- •Participants who have provided informed consent, or for whom the legal guardian has provided informed consent and acknowledged receipt of the study information sheet.
- •Inclusion Criteria - Developmental Coordination Disorder Group
- •Diagnosis of Developmental Coordination Disorder;
- •Participants of either sex and of any ethnicity, aged between 6 and 21 years at the time of recruitment;
- •Total mABC-2 score below the 15th percentile;
- •At least one cognitive functioning index score not lower than 2 standard deviations below the population mean, assessed using standardized tests performed within the previous 12 months, in order to ensure sufficient ability to understand and cooperate with the proposed activities;
- •Participants who have provided informed consent, or for whom the legal guardian has provided informed consent and acknowledged receipt of the study information sheet.
- •Inclusion Criteria - Control Group
- •Participants of either sex and of any ethnicity, aged between 6 and 21 years;
- •Green zone on the mABC-2 Checklist;
- •Participants with cognitive and language abilities adequate to understand the experiment and follow instructions;
- •Participants who have provided informed consent, or for whom the legal guardian has provided informed consent and acknowledged receipt of the study information sheet.
排除标准
- •Exclusion Criteria - Cerebral Palsy and Developmental Coordination Disorder Groups
- •Participants with evident visual or oculomotor impairments;
- •Concomitant general or localized comorbidities/disabilities (e.g., multiple sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.) that may interfere with the ability to understand and perform the study protocol;
- •Presence of pathological cardiopulmonary or cardiovascular conditions;
- •Pregnancy or breastfeeding;
- •Insufficient level of cooperation.
- •Exclusion Criteria - Control Group
- •Participants with evident visual or oculomotor impairments;
- •Concomitant general or localized comorbidities/disabilities (e.g., multiple sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.) that may interfere with the ability to understand and perform the study protocol;
- •Presence of pathological cardiopulmonary or cardiovascular conditions;
- •Pregnancy or breastfeeding;
- •Presence of psychiatric comorbidities;
- •Insufficient level of cooperation.
研究组 & 干预措施
Arm 1: Typically Developing Participants
A total of 80 participants aged 6-21 years with typical development will be recruited. Participants will be stratified by age and sex, with at least five females and five males recruited for each of the following age groups: 6-7, 8-9, 10-11, 12-13, 14-15, 16-17, 18-19, and 20-21 years.
All participants will perform the Virtual Egg Test (VET) during two testing sessions, scheduled 3 or 5 days apart.
干预措施: Virtual Eggs Test (VET) (Device)
Arm 2: Participants with Cerebral Palsy or Developmental Coordination Disorder
A total of 50 participants aged 6-21 years with Cerebral Palsy or Developmental Coordination Disorder will be recruited. Participants will be distributed across the following age groups, irrespective of sex: 6-7, 8-9, 10-11, 12-13, 14-15, 16-17, 18-19, and 20-21 years.
Participants will perform the Virtual Egg Test (VET) during two testing sessions, scheduled 3 or 5 days apart.
干预措施: Virtual Eggs Test (VET) (Device)
结局指标
主要结局
Score of Virtual Eggs Test (VET)
时间窗: Baseline (VET test) and 3-5 days after baseline (VET retest)
The Virtual Eggs Test (VET) is a medical device for assessing fine and gross dexterity by analyzing the participant's ability to carry fragile objects. The main components of the VET are a set of fragile objects, called Virtual Eggs (VEs), a sensorized platform used to guide task execution, and software developed to support the therapist in data acquisition. The VET execution protocol includes two phases: a familiarization phase and a testing phase. The goal of the first phase is to make the participant familiar with the movements to be performed. During the testing phase, participants are asked to carry the selected VEs from one point on the platform to another (passing the barrier) without breaking them and as quickly as possible. At the end of the test, the VET provides a fine dexterity index and a gross dexterity index by combining information regarding the speed of transport of the VEs and the accuracy of grip force regulation.
次要结局
- Score of Box and Blocks Test (BBT)(At baseline)
- Score of Tyneside Pegboard Test (TPT)(At baseline)
- Score of ABILHAND-Kids (only for children with CP)(At baseline)
- Score of Semmes Weinstein monofilament test(At baseline)
- Score of Motor Coordination Questionnaire (DCDQ'07) (for children with DCD)(At baseline)
- Score of Strength and Difficulties Questionnaire (SDQ) (only for children with DCD)(At baseline)
- Score of Conners 3- Self-Report Scale (only for children with DCD)(At baseline)
研究者
Giuseppina Sgandurra
Professor
IRCCS Fondazione Stella Maris