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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Upper limb movement quality in children with neurological deficits [Срок оценки: 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]

Вторичные конечные точки (12)

• ABILHAND-Kids Questionnaire [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: T1: Immediately after completing the treatment period]
• Acceptability questionnaire [Срок оценки: T1: Immediately after completing the treatment period]
• Compliance questionnaire [Срок оценки: T1: Immediately after completing the treatment period]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 6 центров

• 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

Идентификаторы

NCT: NCT07092436 · PhiCube-Pediatric

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗