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

Official title

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

Overview

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.

Interventions

• Device 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, prec

Primary outcome measures

• Upper limb movement quality in children with neurological deficits [Time frame: 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 outcome measures (12)

• ABILHAND-Kids Questionnaire [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 Motor Sequences subtest [Time frame: 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 Arrow subtest [Time frame: 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 Route Finding subtest [Time frame: 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]
• BRIEF P/2 Questionnaire [Time frame: 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]
• Usability questionnaire [Time frame: T1: Immediately after completing the treatment period]
• Acceptability questionnaire [Time frame: T1: Immediately after completing the treatment period]
• Compliance questionnaire [Time frame: T1: Immediately after completing the treatment period]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 6 centers

• IRCCS Eugenio Medea — Bosisio Parini
• IRCCS Fondazione Stella Maris — Calambrone
• Fondazione Don Gnocchi - Centro S. Maria al Mare — Salerno
• IRCCS Istituto Giannina Gaslini — Genova
• Fondazione Don Gnocchi IRCCS - Centro Santa Maria Nascente — Milan
• IRCCS Fondazione Mondino — Pavia

Identifiers

NCT: NCT07092436 · PhiCube-Pediatric

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗