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

NCT07092436 | Recruiting

• 1 other identifier: PhiCube-Pediatric
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

Brief Summary

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 the neuropsychological processes involved and the effects related to auditory feedback perception. The treatment will have a total duration of approximately 3 months and will be organized in 3 weekly sessions lasting 45 minutes each, to reach a total of 30. Descriptive statistics of the clinical and technological variables obtained in the evaluation and rehabilitation phases will be calculated. Subsequently, treatment efficacy analyses through the robotic device are planned, comparing pre-post clinical variables. All collected data will finally be analyzed in order to compare the rehabilitative efficacy of the device with respect to the different groups of participants identified based on diagnostic profile.

Conditions

Congenital and Acquired Neuromotor Disorders; Developmental Coordination Disorder (DCD)

Keywords

Pediatric Rehabilitation; Upper Limb Rehabilitation; Robotic Rehabilitation; Bilateral Training; Neuromotor Disorders

Outcome Measures

Primary Outcomes (1)

• Upper limb movement quality in children with neurological deficits

  Quality of upper limb movement in children with neurological deficits, measured through Melbourne Assessment-2 (MA2), which is able to measure four elements of movement quality: range of motion, precision, dexterity and fluidity.

  Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion

Secondary Outcomes (16)

• ABILHAND-Kids Questionnaire

  Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion

• Leiter-3 Sustained Attention Subtest

  Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion

• NEPSY-II Inhibition Subtest

  Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion

• NEPSY-II Auditory Attention Subtest

  Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion

• NEPSY-II Manual Posture Imitation subtest

  Assessed at 4 time points: - PreT0: 2 months before treatment initiation - T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period - T2: 1 month after treatment completion

Study Arms (1)

PhiCube Bilateral Upper Limb Rehabilitation

EXPERIMENTAL

Device: Robotic bilateral upper limb rehabilitation training

Interventions

Robotic bilateral upper limb rehabilitation training DEVICE

Bilateral upper limb rehabilitation using PhiCube, a modular robotic end-effector device with two motorized axes that can assist or resist patient movements. Treatment consists of 30 sessions over 3 months (3 sessions/week, 45 minutes each) combining motor training with gaming elements specifically designed for pediatric populations. The device's modular design allows customization for individual patient needs and bilateral coordination training. Sessions focus on improving range of motion, precision, dexterity, and movement fluidity through controlled, repetitive, high-intensity exercises in children aged 4-18 years with neuromotor disorders and developmental coordination disorder.

PhiCube Bilateral Upper Limb Rehabilitation

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato: lead
• IRCCS Fondazione Stella Maris: collaborator
• IRCCS Eugenio Medea: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• IRCCS Fondazione Istituto Neurologico Mondino Pavia: collaborator
• Ospedale IRCCS G. Gaslini di Genova: collaborator

Study Sites (6)

IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

RECRUITING

IRCCS Fondazione Stella Maris

Calambrone, PI, 56128, Italy

RECRUITING

Fondazione Don Gnocchi - Centro S. Maria al Mare

Salerno, SA, 84131, Italy

RECRUITING

IRCCS Istituto Giannina Gaslini

Genova, 16147, Italy

RECRUITING

Fondazione Don Gnocchi IRCCS - Centro Santa Maria Nascente

Milan, 20148, Italy

RECRUITING

IRCCS Fondazione Mondino

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Giuseppina Sgandurra, PhD

  IRCCS Fondazione Stella Maris

  STUDY CHAIR

Central Study Contacts

Matteo Malosio, PhD

CONTACT

+39.0341.235.0203; matteo.malosio@cnr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 29, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

IT (6)