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

NCT ID: NCT07092436

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-10-31

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PhiCube Bilateral Upper Limb Rehabilitation

Group Type: EXPERIMENTAL

Robotic bilateral upper limb rehabilitation training

Intervention Type: 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.

Interventions

Robotic bilateral upper limb rehabilitation training

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Fondazione Stella Maris

OTHER

Sponsor Role: collaborator

IRCCS Eugenio Medea

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: collaborator

IRCCS Fondazione Istituto Neurologico Mondino Pavia

UNKNOWN

Sponsor Role: collaborator

Ospedale IRCCS G. Gaslini di Genova

UNKNOWN

Sponsor Role: collaborator

Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Matteo Malosio

Role: CONTACT

matteo.malosio@cnr.it

+39-0341-235-0203

Other Identifiers

PhiCube-Pediatric

Identifier Type: -

Identifier Source: org_study_id