Clinical trial NCT05879952: Virtual Reality and Neuropsychiatric Rehabilitation in Patients With Global Developmental Delay.
Official title: Virtual Reality and Neuropsychiatric Rehabilitation: a Single-blind, Randomized, Controlled Pilot Study in Patients With Global Developmental Delay.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Global Developmental Delay
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 66
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Griffiths-III Mental Development Scale (GMDS-III)
timeFrame: T0 (Baseline) - T1 (6 Months)
measure: Clinical Global Impressions (CGI)
timeFrame: T0 (Baseline) - T1 (6 Months)
measure: Protocol adherence
timeFrame: T0 (Baseline) - T1 (6 Months)
Secondary outcomes:
measure: The Child Behavior Checklist (CBCL 1½-5)
timeFrame: T0 (Baseline) - T1 (6 Months)
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Neurolesi Bonino Pulejo
Study officials:
References:
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