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

Not Applicable

Recruiting

• Conditions: Global Developmental Delay
• Interventions: Behavioral: TAU; Behavioral: TAU + BTsN session

• Registration Number: NCT05879952
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group (CG)	TAU	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.
Experimental Group (EG)	TAU + BTsN session	The group consists of 50 patients diagnosed with global developmental delay, randomply assigned. The patients underwent treatment as usual (TAU) integrated with the use of BTsN pediatric modules, in a 1:1 ratio. All the exercises have been customized by the therapists according to the individual treatment needs, adapting the level of difficulty to the patient's abilities. 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.

Primary Outcome Measures

Name	Time	Method
Protocol adherence	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)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Neurolesi Bonino Pulejo; 🇮🇹 Messina, Italy