NCT07092436 Pediatric Upper-Limb Rehabilitation With PhiCube, a Modular Bilateral End-Effector Device
| NCT ID | NCT07092436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato |
| Condition | Congenital and Acquired Neuromotor Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2025-11-17 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Giuseppina Sgandurra, PhD
STUDY CHAIR
IRCCS Fondazione Stella Maris
Frequently Asked Questions
Who can join the NCT07092436 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 Years, studying Congenital and Acquired Neuromotor Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07092436 currently recruiting?
Yes, NCT07092436 is actively recruiting participants. Contact the research team at matteo.malosio@cnr.it for enrollment information.
Where is the NCT07092436 trial being conducted?
This trial is being conducted at Bosisio Parini, Italy, Calambrone, Italy, Salerno, Italy, Genova, Italy and 2 additional locations.
Who is sponsoring the NCT07092436 clinical trial?
NCT07092436 is sponsored by Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato. The principal investigator is Giuseppina Sgandurra, PhD at IRCCS Fondazione Stella Maris. The trial plans to enroll 54 participants.