Kinematic analysis of hand and arm movement in kids with Down syndrome, CP and healthy children
Official title: Kinematic Analysis of Manual Dexterity and Physiological and Pathological Functional Activity of the Upper Limb in Developmental Age: Pilot Study
Run by IRCCS San Raffaele Roma · NCT07875127 · Data updated 2026-11-12
This study tests how well an instrumented Box and Block Test and motion tracking can measure upper-limb movement in healthy kids and those with pyramidal hemisyndrome or Down syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 4 Years to 18 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 1 site (Rome, Italiy) |
| Status | Recruiting |
| Started | May 30, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07875127 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and adolescents aged 4–18 who can understand and perform the Box and Block Test and meet motor-function criteria for CP hemisyndrome or Down syndrome, with no upper-limb orthopedic limitations.
✕Probably not a fit
Patients with severe upper-limb limitations or cognitive barriers that prevent task performance may not benefit from the insights of this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will use inertial measurement units and the Box and Block Test to collect upper-limb kinematic data in children and adolescents. The goal is to establish normative motion patterns in healthy subjects aged 4–18 and compare them with those of pediatric patients with cerebral palsy-related hemisyndrome and Down syndrome. The study describes inclusion criteria focused on cognitive ability, motor function, and range of motion, while excluding participants with conditions that would confound movement measurements. Data will be analyzed to characterize typical gestures and identify deviations linked to the conditions studied. This is an observational, instrument-based assessment rather than an intervention.
Why it matters
Potential benefit: If successful, the findings could improve how clinicians interpret upper-limb movement data and tailor rehabilitation strategies.
How similar studies have gone: Previous work has used the Box and Block Test and kinematic data to study pediatric motor function, but this study adds standardized instrumented measurements across multiple conditions.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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IRCCS San Raffaele Roma
Rome, Italiy, Italy Recruiting
Study contacts
- Principal investigator: Dr. Sanaz Pournajaf, DPT, PhD — IRCCS San Raffaele Roma
- Study coordinator: Lucia Gatta, PhD
- Email: lucia.gatta@sanraffaele.it
- Phone: +390652253440
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.