跳至主要内容
临床试验/NCT05879952
NCT05879952招募中不适用

Virtual Reality and Neuropsychiatric Rehabilitation: a Single-blind, Randomized, Controlled Pilot Study in Patients With Global Developmental Delay.

IRCCS Centro Neurolesi "Bonino-Pulejo"2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Protocol adherence

研究概览

简要总结

Global Developmental Delay is a disorder characterized by failure achievement of expected milestones in different areas of psychomotor development before 5 years of age. Recent data in the literature have emphasized the importance of early therapeutic intervention. However, few specific interventions have been described in the literature for this disorder.

Among the high-tech tools used in recent years for rehabilitation, the BTs Nirvana is one of the semi-immersive system that can also be used in children, which allows to stimulate cognitive and motor domains. Objective of this single-blind, randomized, controlled study is to evaluate the feasibility and the effectiveness of integrated rehabilitation treatments with the use of BTs Nirvana in patient with Global Developmental Delay.

详细描述

Global Developmental Delay (GDD) is a disorder characterized by failure achievement of expected milestones in different areas of psychomotor development before 5 years of age. The estimated incidence of GDD is 1-3%, an early diagnosis and an efficacy treatment could provide a better long-term prognosis. Recent literature data have underlined the importance of early diagnosis followed by appropriate therapeutic management. In fact, GDDs could evolve into different neurodevelopmental disorders, especially if associated with other risk factors, such as intrauterine growth retardation, nutrient deficiencies, breastfeeding and maternal education, scarce social and economic conditions, poor learning opportunities, inadequate quality of caregiver-child interactions.

In recent decades, the use of virtual reality (VR) for therapeutic reason has become more and more popular for innovative treatments in cognitive-motor domain. Indeed, VR and the interactive playing can motivate children to learn new skills. Among the high-tech tools used in recent years for rehabilitation, the BTs Nirvana (BTsN) is one of the semi-immersive VR that can also be used in children, which allows to stimulate cognitive and motor domains. The aim of this single-blind, randomized, controlled study is to evaluate the feasibility and the effectiveness of integrated rehabilitation treatments with the use of BTsN in patient with Global Developmental Delay.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Months 至 66 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with diagnosis of GDD, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria;
  • age between 12 and 66 months;
  • patients without significant medical conditions such as epilepsy, significant visual and auditory sensory deficits, traumatic brain injury, or other significant genetic disorders.
  • Signed informed consent and the availability of at least one family member to participate in the diagnostic/therapeutic process.

排除标准

  • children not aged between 12 and 66 months;
  • significant medical conditions such as epilepsy, significant visual and auditory sensory deficits, traumatic brain injury, or significant genetic disorders.
  • Informed consent not signed of at least one family member to participate in the diagnostic/therapeutic process.

研究组 & 干预措施

Control Group (CG)

Active Comparator

The group consists of 50 patients diagnosed with global developmental delay randomply assigned.

The patients underwent TAU, consisting in standard neuro-psychomotor training. The treatment was tailored according to each child's goals need and preferences.

Overall, each patient was treated over a period of 6 months, up to a total of n. 48 sessions, twice a week, lasting 45 minutes each.

干预措施: TAU (Behavioral)

结局指标

主要结局

Protocol adherence

时间窗: T0 (Baseline) - T1 (6 Months)

The number of non-delivered treatment sessions will be counted, and the percentage of deviation will be calculated compared to the total number of treatment sessions.

Griffiths-III Mental Development Scale (GMDS-III)

时间窗: T0 (Baseline) - T1 (6 Months)

Assessment tool for children from 0 to 72 months and was for performed to assess Global Quotient (GQ)

Clinical Global Impressions (CGI)

时间窗: T0 (Baseline) - T1 (6 Months)

Scale that allows to quantify and monitor patients' progress and response to treatment over time, providing a judgment on global improvement.

次要结局

  • The Child Behavior Checklist (CBCL 1½-5)(T0 (Baseline) - T1 (6 Months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca Cucinotta

Principal Investigator

IRCCS Centro Neurolesi "Bonino-Pulejo"

研究点 (2)

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