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

NCT ID: NCT05879952

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2025-09-30

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.

Conditions

Global Developmental Delay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group (EG)

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.

Group Type: EXPERIMENTAL

TAU + BTsN session

Intervention Type: BEHAVIORAL

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.

Control Group (CG)

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.

Group Type: ACTIVE_COMPARATOR

TAU

Intervention Type: BEHAVIORAL

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.

Interventions

TAU + 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.

Intervention Type: BEHAVIORAL

TAU

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

standard neuro-psychomotor training + virtual reality game sessions; neuro-psychomotor training

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 66 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: lead

Responsible Party

Francesca Cucinotta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Neurolesi Bonino Pulejo

Messina, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesca Cucinotta, MD, PhD

Role: CONTACT

francesca.cucinotta@irccsme.it

09060128256

IRCCS Centro Neurolesi Bonino Pulejo Bio-parco delle intelligenze e delle Neurofragilità

Role: CONTACT

info@irccsme.it

Facility Contacts

Francesca Cucinotta, PhD

Role: primary

francesca.cucinotta@irccsme.it

09060128256

References

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Other Identifiers

Nir01

Identifier Type: -

Identifier Source: org_study_id