Skip to content

Virtual Reality and Neuropsychiatric Rehabilitation in Patients With Global Developmental Delay.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05879952
Enrollment
100
Registered
2023-05-30
Start date
2020-12-01
Completion date
2025-09-30
Last updated
2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Global Developmental Delay

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.

Interventions

BEHAVIORALTAU + BTsN session

BTsN treatment session included exercises aimed at identifying, finding, chasing or moving objects, with the aim of improving the perceptual-cognitive skills of each patient, through audio-visual stimuli and feedback implementing visuo-spatial skills and spatial cognition, allowing at the same time motor coordination and balance improvement.

BEHAVIORALTAU

neuro-psychomotor training promotes a better organization of global motor skills, improve hand-eye coordination, promote the development of language as communication, enriching representation and symbolization skills.

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Months to 66 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Griffiths-III Mental Development Scale (GMDS-III)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)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.
Protocol adherenceT0 (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.

Secondary

MeasureTime frameDescription
The Child Behavior Checklist (CBCL 1½-5)T0 (Baseline) - T1 (6 Months)This questionnarie is a caregiver report to identifying problem behavior in children.

Countries

Italy

Contacts

Primary ContactFrancesca Cucinotta, MD, PhD
francesca.cucinotta@irccsme.it09060128256
Backup ContactIRCCS Centro Neurolesi Bonino Pulejo Bio-parco delle intelligenze e delle Neurofragilità
info@irccsme.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026