An observational study in Down Syndrome, Hemiparesis and Healthy Subjects, sponsored by IRCCS San Raffaele Roma. Recruiting at 1 site in Italy. Open to participants aged 4 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by IRCCS San Raffaele Roma · Observational
The following study aims to standardize the instrumented BBT for the objective evaluation of upper limb joint kinematics using MoCap on a population of healthy subjects between 4 and 18 years of age. After defining normative data characteristic of the gesture, the study aims to characterize the pathological upper limb movement in pediatric subjects with pyramidal hemisyndrome (cerebral palsy, arteriovenous malformation, brain tumors and head trauma) and Down Syndrome, comparing the data obtained with the normative data.
Upper limb deficit in the pediatric population can result from a number of different conditions or pathologies, including musculoskeletal disorders, cerebral palsy (CP), genetic syndromes, etc. Those undergoing upper limb rehabilitation treatment are generally assessed using functional and motor scales in order to characterize the effectiveness of a specific therapy or the evolution of the pathology over time. There are numerous validated tests to evaluate people with upper limb disabilities. One of the most commonly used tests to evaluate manual dexterity is the Box and Block Test (BBT). In the pediatric field, normative data have been obtained from the administration of the BBT, of healthy individuals aged 6 to 19 years, from 6 to 11 years, and from 3 to 10 years. Zapata-Figueroa V. et al. (2022) conducted a study with the aim of determining the correlation between manual dexterity assessed with the BBT and the performance of daily activities in children with bilateral CP. The BBT score is equal to the number of 2.5 cm wooden cubes transported by the subject over a 15.2 cm high partition in one minute. The subject can grasp one block at a time by choosing it in any order and must transport it over the partition as quickly as possible, with the only requirement that the fingers cross the vertical plane of the partition. The BBT is a useful and widely used measure due to its ease and speed of execution, and its ecological nature. However, this clinical test partially evaluates the motor gesture and ignores the quality of the movement performed by the subject during the execution of the task, i.e. it incorporates this quality into a single qualitative factor. Unlike the level of motor performance, the description of the quality of the movement characterizes the use of involuntary movements that are considered compensations.
One way to perform a detailed analysis of the motor gesture is through the use of Motion Capture (MoCap), which allows the quantitative and objective analysis of how and how much the body segments move relative to each other in a global reference system (kinematics analysis). This analysis is typically performed with stereophotogrammetric systems based on reflective markers and high-resolution infrared cameras. Several studies have demonstrated the usefulness of MoCap to analyze the movements of the upper limbs in patients with stroke, or during ADL.
From the preliminary data obtained from the administration of instrumental BBT, on a population of healthy adults, with Parkinson's disease and with stroke outcomes, it was possible to perform an accurate analysis of the kinematics of the movement and to evaluate any compensatory movements during the execution of cyclic and repeatable motor tasks.
However, there are no studies in the literature that apply the use of BBT with inertial sensors in the pediatric field.
In this context, the following study aims to standardize the instrumented BBT for the objective evaluation of upper limb joint kinematics using MoCap on a population of healthy subjects between 4 and 18 years old. After defining normative data characteristic of the gesture, the study aims to characterize the pathological upper limb movement in pediatric subjects with pyramidal hemisyndrome (PE) (PCI, arteriovenous malformation, brain tumors and head trauma) and Down Syndrome (DS), comparing the data obtained with the normative data.
The SUPERFUN pilot observational study, lasting 36 months, will be carried out at the IRCCS San Raffaele which owns the IMU Movit G1-3D system (Captiks, Italy). The recruitment of subjects and the acquisition of data will take place at the IRCCS San Raffaele. The processing of data with inertial sensors will take place at the IRCCS San Raffaele.
The SUPERFUN study will be developed in 36 months, and includes 3 phases structured as follows:
Phase 1: recruitment of subjects and data acquisition Phase 2: processing of data with inertial sensors Phase 3: statistical analysis of data
438 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's planned enrollment of 60 is below the median of 141 across 145 observational studies indexed under Down Syndrome.
Browse Down Syndrome studies →IRCCS San Raffaele Roma is the lead sponsor of 68 studies on the registry; 27 are open to participants now.
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The recruitment will include 20 healthy pediatric subjects, without upper limb pathologies (peripheral neurological damage, severe inflammatory degenerative joint pathologies, outcomes of fractures or trauma), 20 pediatric patients with PE and 20 pediatric patients with DS, enrolled at the IRCCS San Raffaele.
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For pyramidal hemisyndrome:
For Down syndrome:
-genetic diagnosis
Exclusion Criteria:
healthy subjects, aged 4 to 18 years, without any upper limb disorder, collaborative
Device: Inertial Measurement Unit and Box and Block test
Subjects with Down syndrome, genetic diagnosis, aged 4 to 18 years
Device: Inertial Measurement Unit and Box and Block test
Subjects with pyramidal hemisyndrome, aged 4 to 18 years with moderate/mild motor impairment assessed with: * Manual Ability Classification System (MACS): with values from 1 to 2 (Eliasson AC et al., 2006) * Bimanual Fine Motor Function Scale (BFMF): with values from 1 to 4 (Beckung \& Hagberg, 2002) * Modified Ashworth Scale upper limb (MAS): with values ≤2
Device: Inertial Measurement Unit and Box and Block test
Subjects will be assessed during Standard Box and Block Test, Targeted and Dual Task Box and Block Test with Inertial Measurement Units. The subject is seated on a stable stool adjustable in height so that the hip and knee angles are formed at 90°. A height-adjustable table is placed in front of the subject: the heights of the table and the seat are adjusted so that the subject forms 90-degree elbow angles by resting the forearms on the table. Once the system has been calibrated and the inertial sensors applied, the patient will be asked to perform the task. Dual Task BBT: the dual task exercise will involve the execution of the BBT, together with the selective naming of the colors. During the transfer of the cubes onto the numbered surface corresponding to their initial position, the participant will be required to focus attention exclusively on the verbalization of the colors of the red and green cubes, without attributing names to the cubes of other colors.
Smoothness of upper-limb movement measured by the DLJ (dimensionless jerk index)
Dimensionless Jerk Index is and index that express the smoothness or fluidity of a movement performed by the upper limb. IMU(Inertial Measurement Units)-based targeted Box and Block Test (t-BBT) represents an instrumental assessment of manual dexterity that will be conducted using a sensorized and targeted BBT (tBBT). 16 wooden blocks, 2.5cm3 in size, are placed on a 4x4 grid in the container closest to the limb to be assessed. The subject must grasp one block at a time with a pre-established order (numbering in figure 2), transfer it over the dividing wall and release it on the corresponding position of a 4x4 grid present in the other container, as quickly as possible. Acquisition duration: time necessary to complete the exercise. After 2 minutes the acquisition is however interrupted. The DLJ is a normalized value (without unit of measure) calculated from the kinematic parameters extracted from the IMUs' raw data.
Time frame: at day 0
Intensity of muscle activity (milliVolt - mV)
All subjects performs the targeted Box and Block Test (t-BBT) equipped with 6 electromyographic sensors to detect muscle activity (expressed in milliVolt - mV) by superficial electromyography (sEMG). The sensors are positioned on both upper limbs to detect the signal of the muscles listed below: * Anterior deltoid * Posterior deltoid * Biceps brachii * Triceps lateral head * Brachioradialis * Flexor carpi ulnaris
Time frame: at Day 0
Dimensionless Jerk Index (DLJ) under Dual-Task condition
Instrumental assessment of manual dexterity will be conducted using a sensorized and dual task BBT: the dual task exercise will involve the execution of the BBT, together with the selective naming of the colors. During the transfer of the cubes onto the numbered surface corresponding to their initial position, the participant will be required to focus attention exclusively on the verbalization of the colors of the red and green cubes, without attributing names to the cubes of other colors. In this context it is possible to calculate the Dimensionless Jerk index (DLJ) starting from the raw data extracted by the IMUs.
Time frame: The assessment will be conducted at Day 0.
Passive Range of Motion (pROM)
ROM is the arc of motion available at a single joint or series of joints. It is the angle through which the joint moves from the anatomical position to the extreme limit of its motion in a particular direction. In essence, it is the extent to which a part of the body can be moved around a joint or a fixed point.
Time frame: The assessment will be conducted at Day 0.
Trunk Control Test (TCT)
The TCT measures four simple aspects of trunk movement. There are 4 items: 1) Rolling to weak side 2) Rolling to strong side 3) Balance in sitting position 4) Sit up from lying down Total score range: 0 (minimum) to 100 (maximum, indicating better performance). Score of each item: (0, 12 or 25) 0 = unable to
Time frame: The assessment will be conducted at Day 0.
Bell Test
The Modified Bell Test is a test of selective and sustained attention. The subject is presented with four different sheets of paper, each of which contains not only thirty-five bells but also other figures representing animate and inanimate objects (for example, houses, trees, horses, fish, etc.). The subject is asked to cross out all the bells on the sheet as quickly as possible. From the administration of the test, two types of scores are obtained: the speed score, that is, the number of bells found in the first 30 seconds of searching, and the accuracy score, which reports the number of bells found in the 120 seconds required by the test. The normative data refer to the different ages of the subjects (from 4 to 14 years) and to their performances for each sheet administered and for the total of the four sheets. In this work, only the speed and accuracy scores were used in the total of the four sheets.
Time frame: The assessment will be conducted at Day 0.
Box and Block Test (BBT)
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box should be oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. In order to practice and register baseline scores, the test should begin with the unaffected upper limb.
Time frame: The assessment will be conducted at Day 0.
Quality of Upper Extremity Skills Test (QUEST)
The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. The QUEST is both reliable and valid.The purpose of the QUEST is to evaluate quality of upper extremity function in four domains: dissociated movement, grasp, protective extension, and weight bearing. Validation studies have been completed with children with cerebral palsy, aged 18 months to 8 years. 36 items assessing dissociated movements, grasp, protective extension, and weight bearing.
Time frame: The assessment will be conducted at Day 0.
Pediatric Evaluation of Disability Inventory (PEDI)
The PEDI assesses functional skills, level of independence, and the extent of modifications required to perform functional activities in young children. The PEDI measures functional status in the domains of self-care, mobility, and social function across the following 3 measurement scales: Part I: Functional Skills Part II: Caregiver Assistance Part III: Modifications Scores are distributed from 0-100, with higher scores representing greater functionality. Scaled scores can be used for children of all ages because scaled scores are not adjusted for age. The PEDI is a paper-based assessment administered via parent/caregiver report, structured interview, observation or professional judgement of therapists or teachers, or by a combination of methods.
Time frame: at Day 0
Plan to share: Undecided — The data will be shared upon direct request to the study Principal Investigator and the relative Ethics Committee Approval.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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IRCCS San Raffaele Roma