Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Heart rate (HR) |
To assess the safety of the stimulation, the HR (beats per minute, bpm) will be checked. HR values will be check during a two minutes rest condition. For this measure, more caution will be held with values lower than 70 or higher than 120 bpm in 6 to 12 years old children and lower than 60 or higher than 100 bpm in 12 to 18 years old adolescents. |
in the first 2 minutes and after 20 minutes of stimulation session |
|
| Other |
Oxygen saturation (SPO2) |
To assess the safety of the stimulation, the SPO2 (%) will be checked, too. SPO2 values will be check during a two minutes rest condition. Cases with SPO2 values lower than 93% will be carefully checked. |
in the first 2 minutes and after 20 minutes of stimulation session |
|
| Other |
Tolerability of the stimulation |
Tolerability will be assessed through a 10 centimetres Visual Analogue Scale by asking to indicate the level of discomfort during the stimulation, and to rate on Child-friendly Likert scales the intensity of the following sensations: itching, pain, burning, heat, pinching, iron taste, fatigue, visual sensations like flashes, eyelid movements, others. For each sensation the patients will be asked to express a value of perception strength that ranges from 0 (absence) to 4 (strong). Higher values will suggest stronger discomfort. |
immediately after every stimulation sessions of the 10-days training |
|
| Other |
number of patients who accept to complete the 2-week training |
This value will be expressed as percentage, with respect to the total number of recruited patients. Higher values will suggest higher feasibility of the training |
1-2 days after the end of the training (t1) |
|
| Other |
number of sessions completed per patient |
This value will be expressed as mean percentage of session completed (across patients), with respect to the total number of session planned for the training. Higher values will suggest higher feasibility of the training |
1-2 days after the end of the training (t1) |
|
| Other |
acceptability of the training |
The acceptability will be assessed by asking to the child/adolescent and his/her parents subjective evaluation of training accessibility and efficacy. Questions like "I find it difficult to motivate my child for doing the training"/ "I find it difficult to start the training"; or "I would suggest this training to other people I know"/ "I think other people I know would enjoy doing this training" will be rated from 1 (completely disagree) to 5 (completely agree). Response will be reversed in the negative items, so that higher scores will suggest more positive evaluation/higher acceptability. |
1-2 days after the end of the training (t1) |
|
| Primary |
Assisting Hand Assessment (AHA) |
This scale enables to quantify the assistance provided by the more affected hand to the less affected hand during bimanual activities. This observation-based, criterion-referenced assessment highlights a person's typical performance, emphasizing practical functionality over maximal capacity, and serves as a reliable measure of change over time. The scale comprised 20 items, scored on a 4-point Likert scale, from 1 to 4. The total score indicates how well the more affected hand is used as an assisting hand. A score of 20 means poor performance (the hand is not used as an assisting hand); a score of 80 means that the hand is used effectively. The results are converted for each of the three scales to logits by a Rasch analysis, on a 0-to-100 scale (with higher scores suggesting better use). |
1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
|
| Primary |
Box and Block Test (BBT) |
This test is designed to measure manual dexterity. It is quick, simple, and cost- effective. It involves a box with a partition in the middle placed on a table, with a total of 150 blocks on one side of the partition. The score of the test is given by the number of blocks transported within a minute. Higher values suggest better performance. The BBT provides a reliable and objective measurement of manual dexterity, making it valuable for evaluating functional outcomes and monitoring progress in rehabilitation programs over a short period of time. |
1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
|
| Primary |
Visuomotor task |
The visuomotor task is an ad hoc computer based task. It involves a mouse click- and-drag operation where an object appears at the center of the screen. The objective is to drag and drop the object to the location indicated by a previously presented arrow, pointing towards a target object within a configuration of objects. Participants are required to focus on the arrow's direction, swiftly and accurately moving the central object to its designated target location. This task enables the measurement of movement time (in milliseconds; consisting in the time necessary to move the object in the target position); precision error (calculated as the distance, in pixels, between the drop position of the object and the actual target position); the proportion of overtime errors (the percentage of trials in which responses are too slow). Smaller values of Movement time, Precision error and overtime errors will suggest better performance. |
1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
|
| Secondary |
Canadian Occupational Performance Measure (COPM) |
This is a client-centered, semi-structured interview used in occupational therapy to identify the problems experienced by the patients. This interview engages the patient in recognizing daily occupations of importance that he/she want to do, need to do, or are expected to do but is unable to accomplish. Upon the identification of the problems experienced in patient's everyday-life activities the patient is asked to rate the importance of each activity in his/her life though a 10-points rating scale and then, to select up to five problems to be addressed during the intervention. Lastly, the patient is asked to rate on a 10 points scale his/her own level of performance and satisfaction in performing that activity for each of the five problems (from 0, low performance or low satisfaction to 10, high performance or high satisfaction). |
1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
|
| Secondary |
Children's Hand-Use Experience Questionnaire (CHEQ) |
The questionnaire includes 27 bimanual activities. Each activity is rated on three scales measuring: i) the perceived efficacy of the activity ("How do you think the child's hand works?") from 1 (Bad / not used hand) to 4 (Good efficacy); ii) the amount of assistance and the time needed to perform the activity ("How much time does your child need to do the whole task, compared to peers?) from 1 (Considerably longer) to 4 (Equally long time compared to other peers); and iii) the child's satisfaction with their performance ("Is your child bothered by his/her reduced hand/arm function during this activity?") from 1 ("It bothers him/her a lot") to 4 ( "It does not bother him/her at all"). The questionnaire provides a result corresponding to the summary of the ratings. The results are converted for each of the three scales to logits by a Rasch analysis, on a 0-to-100 scale (with higher scores suggesting better performance/satisfaction). |
1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
|
| Secondary |
Melbourne Assessment 2 (MA2) |
This scale allows evaluating the unimanual performance of both the more and less affected hand. It measures four elements of upper limb movement quality: movement range, accuracy, dexterity and fluency. It consists of 14 test items that require children to interact (by reaching, grasping, releasing and manipulating) with simple objects. Movement elements are scored on a 3-, 4-, or -5 point scale according to specific criteria. Scores are arranged into the 4 sub-scales (movement range, accuracy, dexterity and fluency) according to the element of movement being rated. A child's total raw score for each sub-scale is converted to a percentage of the maximum possible score for that sub-scale, with higher scores indicating better performance. |
1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
|
| Secondary |
Gross Motor Function Measure (GMFM-66) |
It is a standardized observational tool used by healthcare professionals to evaluate and quantify the gross motor abilities and limitations of children with CP. It assesses 66 motor skills across five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. Each skill is scored on a 4-point scale, ranging from 0 (does not initiate) to 3 (performs fully). |
1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
|
| Secondary |
Vineland Adaptive Behavior Scale Version 2 (VABS II) |
This is a tool designed to assess adaptive behavior in individuals from birth to age 90. It assesses 11 subdomains of adaptive behavior grouped into four domains; sums of these scores are standardized into Communication, Daily Living Skills, Socialization and Motor Skills domain standard scores. Sums of the domain standard scores are then standardized into the Adaptive Behavior Composite score ranging from 20 to 160 (mean=100; standard deviation= 15). |
1-2 days before the start of training (t0), three months after the end of the training (t2) |
|
| Secondary |
Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL) |
This is a widely employed, brief, and standardized self-reporting tool for assessing health-related quality of life in children and young individuals. The measure can be completed by parents (the Proxy Report) as well as children and young people (the Self-Report) with versions available for children and young people aged 5-7, 8-12, and 13-18. Parent-rated versions are available for children aged 2-4, 5-7, 8-12, and 13-18. The versions from 5 to 18 years comprise 35 items comprising 7 dimensions: Daily Activities; School Activities; Movement and Balance; Pain and Hurt; Fatigue; Eating Activities; Speech and Communication. For each item, consisting in everyday life action, it is required to indicate how much of a problem each item has been in the past month with response options from 0 (never a problem) to 4 (almost always a problem). The items are reverse scored and transformed to a 0-100 scale, with higher scores indicating better health related quality of life. |
1-2 days before the start of training (t0), three months after the end of the training (t2) |
|
| Secondary |
Cortical rhythms at rest and during the Visuomotor task |
Cortical rhythms will be recorded using EEG electrodes placed over the fronto-central regions to investigate potential changes in EEG power in gamma (30- 100 Hz) bands. We will investigate the event-related synchronization/desynchronization (ERS/ERD) of this frequency, reflecting an increase or decrease in power within the EEG signal during the visuomotor task compared to the resting state condition. This analysis will focus on regions associated with cognitive and motor control, aiming to detect any changes indicative of treatment effects. |
1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
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