Down SyndromeSUPERFUNNCT07875127
Kinematic Analysis of Manual Dexterity
An observational study of Down Syndrome and Hemiparesis, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Hemiparesis, Healthy Subjects
- What is being tested?
- Inertial Measurement Unit and Box and Block test
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- Cognitive state that allows understanding and subsequent correct execution of the motor activity required during the execution of the BBT
- Trunk Control Test: item 3 = 25 (Collin \& Wade, 1990)
- Absence of orthopedic problems at the level of the upper limb
- For pyramidal hemisyndrome:
- Moderate/mild motor impairment assessed with:
- Manual Ability Classification System (MACS): with values from 1 to 2 (Eliasson AC et al., 2006)
Show all 10Show fewer
- Bimanual Fine Motor Function Scale (BFMF): with values from 1 to 4 (Beckung \& Hagberg, 2002)
- Modified Ashworth Scale upper limb (MAS): with values ≤2
- For Down syndrome:
- -genetic diagnosis
Who cannot join
- Presence of joint pathologies that limit the range of motion of the upper limbs
- Presence of concomitant neurological pathologies that influence motor function
- Inability (motor, cognitive) to maintain the described position for the time necessary to perform the test
- Lack of collaboration of the subject
- Participants who have not signed the informed consent to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Carlotta Maria Manzia, DT contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Roma
Rome, Italiy, 00166
Dr. Sanaz Pournajaf, DPT, PhD, +39 0652252405 ext. 32405, sanaz.pournajfa@sanraffaele.it
Dr. Carlotta Maria Manzia, MSc., DT
About this study
Official title: Kinematic Analysis of Manual Dexterity and Physiological and Pathological Functional Activity of the Upper Limb in Developmental Age: Pilot Study
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.
Read the detailed description
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
- Conditions
- Down Syndrome, Hemiparesis, Healthy Subjects
- Being tested
- Inertial Measurement Unit and Box and Block test
- Keywords
- Upper Limb, Hand, Rehabilitation, Quality of Life, Activities of Daily Living (ADL), Development Age, Manual Dexterity, Kinematics Analysis
- Medical subject headings
- Down Syndrome, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inertial Measurement Unit and Box and Block testDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children | healthy subjects, aged 4 to 18 years, without any upper limb disorder, collaborative Receives: Device: Inertial Measurement Unit and Box and Block test | |
| Down Syndrome | Subjects with Down syndrome, genetic diagnosis, aged 4 to 18 years Receives: Device: Inertial Measurement Unit and Box and Block test | |
| Pyramidal hemisyndrome | 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 Receives: Device: Inertial Measurement Unit and Box and Block test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at day 0
Secondary outcomes (1)
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
Measured: at Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start30 May 2024
- Primary completion30 Sep 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Sanaz Pournajaf, DPT, PhD, Principal investigator, IRCCS San Raffaele Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875127
- Sponsor's protocol ID
- 72/SR/23
- Acronym
- SUPERFUN
- Status last verified
- Oct 2026
- First submitted
- 15 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be shared upon direct request to the study Principal Investigator and the relative Ethics Committee Approval.
Publications
Alt Murphy M, Resteghini C, Feys P, Lamers I. An overview of systematic reviews on upper extremity outcome measures after stroke. BMC Neurol. 2015 Mar 11;15:29. doi: 10.1186/s12883-015-0292-6.
PubMed 25880033Platz T, Pinkowski C, van Wijck F, Kim IH, di Bella P, Johnson G. Reliability and validity of arm function assessment with standardized guidelines for the Fugl-Meyer Test, Action Research Arm Test and Box and Block Test: a multicentre study. Clin Rehabil. 2005 Jun;19(4):404-11. doi: 10.1191/0269215505cr832oa.
PubMed 15929509Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
PubMed 3160243Torres Espinosa LY, Ortiz-Corredor F, Eslava Schmalbach JH, Mendoza-Pulido C. [Validating and standardizing children's box and block test normal values]. Rev Salud Publica (Bogota). 2014 May-Jun;16(3):417-30. Spanish.
PubMed 25521956Jongbloed-Pereboom M, Nijhuis-van der Sanden MW, Steenbergen B. Norm scores of the box and block test for children ages 3-10 years. Am J Occup Ther. 2013 May-Jun;67(3):312-8. doi: 10.5014/ajot.2013.006643.
PubMed 23597689Zapata-Figueroa V, Ortiz-Corredor F. Assessment of Manual Abilities Using the Box and Block Test in Children with Bilateral Cerebral Palsy. Occup Ther Int. 2022 Feb 22;2022:9980523. doi: 10.1155/2022/9980523. eCollection 2022.
PubMed 35281716Alouche SR, Molad R, Demers M, Levin MF. Development of a Comprehensive Outcome Measure for Motor Coordination; Step 1: Three-Phase Content Validity Process. Neurorehabil Neural Repair. 2021 Feb;35(2):185-193. doi: 10.1177/1545968320981955. Epub 2020 Dec 22.
PubMed 33349134Cappozzo A, Della Croce U, Leardini A, Chiari L. Human movement analysis using stereophotogrammetry. Part 1: theoretical background. Gait Posture. 2005 Feb;21(2):186-96. doi: 10.1016/j.gaitpost.2004.01.010.
PubMed 15639398Tedim Cruz V, Bento VF, Ribeiro DD, Araujo I, Branco CA, Coutinho P. A novel system for automatic classification of upper limb motor function after stroke: an exploratory study. Med Eng Phys. 2014 Dec;36(12):1704-10. doi: 10.1016/j.medengphy.2014.09.009. Epub 2014 Oct 1.
PubMed 25280582Li J, Pan B, Jin T, Huang Z, Ye S, Wu J, Huang Z, Xie B, Luo C, Wang C. A single task assessment system of upper-limb motor function after stroke. Technol Health Care. 2016 Apr 29;24 Suppl 2:S707-15. doi: 10.3233/THC-161199.
PubMed 27177101Gates DH, Walters LS, Cowley J, Wilken JM, Resnik L. Range of Motion Requirements for Upper-Limb Activities of Daily Living. Am J Occup Ther. 2016 Jan-Feb;70(1):7001350010p1-7001350010p10. doi: 10.5014/ajot.2016.015487.
PubMed 26709433Romano P, Pournajaf S, Ottaviani M, Gison A, Infarinato F, Mantoni C, De Pandis MF, Franceschini M, Goffredo M. Sensor Network for Analyzing Upper Body Strategies in Parkinson's Disease versus Normative Kinematic Patterns. Sensors (Basel). 2021 May 31;21(11):3823. doi: 10.3390/s21113823.
PubMed 34073123
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematic Analysis of Manual Dexterity and Physiological and Pathological Functional Activity of the Upper Limb in Developmental Age: Pilot Study
- ClinicalTrials.gov ID
- NCT07875127
- Acronym / sponsor ID
- SUPERFUN / 72/SR/23
- Conditions
- Down Syndrome, Hemiparesis, Healthy Subjects
- Keywords
- Upper Limb, Hand, Rehabilitation, Quality of Life, Activities of Daily Living (ADL), Development Age, Manual Dexterity, Kinematics Analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy children | – | Device: Inertial Measurement Unit and Box and Block testhealthy subjects, aged 4 to 18 years, without any upper limb disorder, collaborative |
| Down Syndrome | – | Device: Inertial Measurement Unit and Box and Block testSubjects with Down syndrome, genetic diagnosis, aged 4 to 18 years |
| Pyramidal hemisyndrome | – | Device: Inertial Measurement Unit and Box and Block testSubjects 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 |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- Cognitive state that allows understanding and subsequent correct execution of the motor activity required during the execution of the BBT
- Trunk Control Test: item 3 = 25 (Collin \& Wade, 1990)
- Absence of orthopedic problems at the level of the upper limb
- Moderate/mild motor impairment assessed with:
- Manual Ability Classification System (MACS): with values from 1 to 2 (Eliasson AC et al., 2006)
Key exclusion criteria (5 listed)
- Presence of joint pathologies that limit the range of motion of the upper limbs
- Presence of concomitant neurological pathologies that influence motor function
- Inability (motor, cognitive) to maintain the described position for the time necessary to perform the test
- Lack of collaboration of the subject
- Participants who have not signed the informed consent to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inertial Measurement Unit and Box and Block testSubjects 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. | Device | Down Syndrome, Healthy children, Pyramidal hemisyndrome |
Primary outcome
Smoothness of upper-limb movement measured by the DLJ (dimensionless jerk index)
Time frame: at day 0
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.
1 secondary outcome
Intensity of muscle activity (milliVolt - mV)
Time frame: at Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 25880033Alt Murphy M, Resteghini C, Feys P, Lamers I. An overview of systematic reviews on upper extremity outcome measures after stroke. BMC Neurol. 2015 Mar 11;15:29. doi: 10.1186/s12883-015-0292-6.
- Background: PubMed 15929509Platz T, Pinkowski C, van Wijck F, Kim IH, di Bella P, Johnson G. Reliability and validity of arm function assessment with standardized guidelines for the Fugl-Meyer Test, Action Research Arm Test and Box and Block Test: a multicentre study. Clin Rehabil. 2005 Jun;19(4):404-11. doi: 10.1191/0269215505cr832oa.
- Background: PubMed 3160243Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
- Background: PubMed 25521956Torres Espinosa LY, Ortiz-Corredor F, Eslava Schmalbach JH, Mendoza-Pulido C. [Validating and standardizing children's box and block test normal values]. Rev Salud Publica (Bogota). 2014 May-Jun;16(3):417-30. Spanish.
- Background: PubMed 23597689Jongbloed-Pereboom M, Nijhuis-van der Sanden MW, Steenbergen B. Norm scores of the box and block test for children ages 3-10 years. Am J Occup Ther. 2013 May-Jun;67(3):312-8. doi: 10.5014/ajot.2013.006643.
- Background: PubMed 35281716Zapata-Figueroa V, Ortiz-Corredor F. Assessment of Manual Abilities Using the Box and Block Test in Children with Bilateral Cerebral Palsy. Occup Ther Int. 2022 Feb 22;2022:9980523. doi: 10.1155/2022/9980523. eCollection 2022.
- Background: PubMed 33349134Alouche SR, Molad R, Demers M, Levin MF. Development of a Comprehensive Outcome Measure for Motor Coordination; Step 1: Three-Phase Content Validity Process. Neurorehabil Neural Repair. 2021 Feb;35(2):185-193. doi: 10.1177/1545968320981955. Epub 2020 Dec 22.
- Background: PubMed 15639398Cappozzo A, Della Croce U, Leardini A, Chiari L. Human movement analysis using stereophotogrammetry. Part 1: theoretical background. Gait Posture. 2005 Feb;21(2):186-96. doi: 10.1016/j.gaitpost.2004.01.010.
- Background: PubMed 25280582Tedim Cruz V, Bento VF, Ribeiro DD, Araujo I, Branco CA, Coutinho P. A novel system for automatic classification of upper limb motor function after stroke: an exploratory study. Med Eng Phys. 2014 Dec;36(12):1704-10. doi: 10.1016/j.medengphy.2014.09.009. Epub 2014 Oct 1.
- Background: PubMed 27177101Li J, Pan B, Jin T, Huang Z, Ye S, Wu J, Huang Z, Xie B, Luo C, Wang C. A single task assessment system of upper-limb motor function after stroke. Technol Health Care. 2016 Apr 29;24 Suppl 2:S707-15. doi: 10.3233/THC-161199.
- Background: PubMed 26709433Gates DH, Walters LS, Cowley J, Wilken JM, Resnik L. Range of Motion Requirements for Upper-Limb Activities of Daily Living. Am J Occup Ther. 2016 Jan-Feb;70(1):7001350010p1-7001350010p10. doi: 10.5014/ajot.2016.015487.
- Background: PubMed 34073123Romano P, Pournajaf S, Ottaviani M, Gison A, Infarinato F, Mantoni C, De Pandis MF, Franceschini M, Goffredo M. Sensor Network for Analyzing Upper Body Strategies in Parkinson's Disease versus Normative Kinematic Patterns. Sensors (Basel). 2021 May 31;21(11):3823. doi: 10.3390/s21113823.
- Individual participant dataSharing planned: Undecided. The data will be shared upon direct request to the study Principal Investigator and the relative Ethics Committee Approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Carlotta Maria Manzia, DT contact
Dr. Sanaz Pournajaf, DPT, PhD principal investigator
IRCCS San Raffaele Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome and Hemiparesis, run by IRCCS San Raffaele Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucia Gatta, PhD (+390652253440, lucia.gatta@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoothness of upper-limb movement measured by the DLJ (dimensionless jerk index) (time frame: at day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07875127, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.