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Pediatric Upper-Limb Rehabilitation With PhiCube, a Modular Bilateral End-Effector Device

RecruitingNAAges 4 Years - 18 YearsAllIstituto di Sistemi e Tecnologie Industriali Inte…
NCT07092436 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The present investigation is configured as a multicenter clinical study in a within-group pilot phase. This study aims to investigate primarily the feasibility of use and effectiveness of a treatment for upper limb function in children aged 4 to 18 years with congenital and acquired neuromotor disorders through a new portable robotic system, called PhiCube, designed for bilateral neuromotor rehabilitation of the upper limbs in subjects with neuromotor disorders. In order to specifically investigate also the potential impact of PhiCube on movement planning aspects, the study will also involve a small group of children aged 4 to 18 years with Developmental Coordination Disorder (DCD). Before (PreT0 and T0) and after (T1 and T2) treatment, standardized assessment tests will be administered. Regarding the investigation objectives reported above, the primary outcome measure will be the Mel

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📋 Eligibility rules (as published)
Inclusion Criteria: * For subjects with congenital and acquired neuromotor disorders: * Diagnosis of congenital and acquired neuromotor disorders * Age between 4 and 18 years at the time of recruitment * Modified Ashworth Scale (MAS) less than 3 * MACS level I-IV * Sufficient capacity to understand the proposed activities * Availability to attend the facility * For subjects with developmental coordination disorder (DCD): * Diagnosis of developmental coordination disorder (DCD) * Age between 4 and 18 years at the time of recruitment * Sufficient capacity to understand the proposed activities * Availability to attend the facility Exclusion Criteria: * For subjects with congenital and acquired neuromotor disorders: * Severe sensory deficits * Onset of pathologies that prevent participation * Worsening of pre-existing comorbidities * For subjects with developmental coordination disorder (DCD): * Severe sensory deficits * Onset of pathologies that prevent participation * Worsening of pre-existing comorbidities
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What it tests

  • Robotic bilateral upper limb rehabilitation training
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Where

6 sites
IRCCS Eugenio Medea
Bosisio Parini, Italy
IRCCS Fondazione Stella Maris
Calambrone, Italy
Fondazione Don Gnocchi - Centro S. Maria al Mare
Salerno, Italy
IRCCS Istituto Giannina Gaslini
Genova, Italy
Fondazione Don Gnocchi IRCCS - Centro Santa Maria Nascente
Milan, Italy
IRCCS Fondazione Mondino
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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