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NCT07875127
Kinematic Analysis of Manual Dexterity
Conditions: Down Syndrome, Hemiparesis, Healthy Subjects
Sex: All
Ages: 4 Years – 18 Years
Healthy volunteers: Yes
Enrollment: 60
Sponsor: IRCCS San Raffaele Roma
Location: IRCCS San Raffaele Roma Rome Italiy
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. 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.
Eligibility Criteria
Inclusion Criteria:
* 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)
* 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
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07875127). StuddyBuddy aggregates publicly available trial information.