Pediatric Upper-Limb Rehabilitation With PhiCube, a Modular Bilateral End-Effector Device.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 主要终点
- Upper limb movement quality in children with neurological deficits
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Upper limb movement quality in children with neurological deficits
时间窗: 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
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.
次要结局
- 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)
- NEPSY-II Arrow 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 Route Finding 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 Motor Sequences 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)
- Acceptability questionnaire(T1: Immediately after completing the treatment period)
- Compliance questionnaire(T1: Immediately after completing the treatment period)
- Trajectory error(- T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period)
- Bilateral coordination(- T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period)
- 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 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)
- BRIEF P/2 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)
- Audio Feedback Effect Evaluation(- T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period)
- Usability questionnaire(T1: Immediately after completing the treatment period)
- Movement smoothness(- T0: Immediately before starting PhiCube treatment - T1: Immediately after completing the treatment period)
- 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)