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

NCT07092436 · Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato · Updated 2 April 2026

What is being tested
Robotic bilateral upper limb rehabilitation training
For
Congenital and Acquired Neuromotor Disorders; Developmental Coordination Disorder (DCD)
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 4 years to 18 years. About 54 people. The full rules are on the registry page.
Where
Italy (6 sites)
When
Starts or started 17 Nov 2025, ends Nov 2026. Registered 29 July 2025.
Results
None posted yet.

In the researchers' words

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 Melbourne Assessment-2 (MA2), a standardized, valid and reliable instrument for evaluating the quality of upper limb movement in children with neurological deficits, capable of measuring four elements of movement quality: range of motion, accuracy, dexterity and fluency. As secondary outcome measures, Abilhand-Kids has been chosen, a brief questionnaire that measures 21 main daily bimanual activities completed by the parent or caregiver, and various subtests and questionnaires aimed at evaluating…
ClinicalTrials.gov, NCT07092436

Sites

  • IRCCS Eugenio MedeaBosisio Parini, LC, Italy
  • IRCCS Fondazione Stella MarisCalambrone, PI, Italy
  • Fondazione Don Gnocchi - Centro S. Maria al MareSalerno, SA, Italy
  • IRCCS Istituto Giannina GasliniGenova, Italy
  • Fondazione Don Gnocchi IRCCS - Centro Santa Maria NascenteMilan, Italy
  • IRCCS Fondazione MondinoPavia, Italy