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

NCT05879952 | Unknown

• 1 other identifier: Nir01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Global Developmental Delay

Outcome Measures

Primary Outcomes (3)

• Griffiths-III Mental Development Scale (GMDS-III)

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

  T0 (Baseline) - T1 (6 Months)

• Clinical Global Impressions (CGI)

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

  T0 (Baseline) - T1 (6 Months)

• Protocol adherence

  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.

  T0 (Baseline) - T1 (6 Months)

Secondary Outcomes (1)

• The Child Behavior Checklist (CBCL 1½-5)

  T0 (Baseline) - T1 (6 Months)

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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.

Behavioral: TAU + BTsN session

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.

Behavioral: TAU

Interventions

TAU + BTsN session 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.

Also known as: standard neuro-psychomotor training + virtual reality game sessions

Experimental Group (EG)

TAU 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.

Also known as: neuro-psychomotor training

Control Group (CG)

Eligibility Criteria

• Age: 12 Months - 66 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Neurolesi Bonino Pulejo

Messina, 98124, Italy

RECRUITING

Related Publications (9)

• Srour M, Mazer B, Shevell MI. Analysis of clinical features predicting etiologic yield in the assessment of global developmental delay. Pediatrics. 2006 Jul;118(1):139-45. doi: 10.1542/peds.2005-2702.

  PMID: 16818559 BACKGROUND

• Alderman H, Behrman JR, Glewwe P, Fernald L, Walker S. Evidence of Impact of Interventions on Growth and Development during Early and Middle Childhood. In: Bundy DAP, Silva ND, Horton S, Jamison DT, Patton GC, editors. Child and Adolescent Health and Development. 3rd edition. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2017 Nov 20. Chapter 7. Available from http://www.ncbi.nlm.nih.gov/books/NBK525234/

  PMID: 30212122 BACKGROUND

• Thomaidis L, Zantopoulos GZ, Fouzas S, Mantagou L, Bakoula C, Konstantopoulos A. Predictors of severity and outcome of global developmental delay without definitive etiologic yield: a prospective observational study. BMC Pediatr. 2014 Feb 12;14:40. doi: 10.1186/1471-2431-14-40.

  PMID: 24521451 BACKGROUND

• Caliendo M, Di Sessa A, D'Alterio E, Frolli A, Verde D, Iacono D, Romano P, Vetri L, Carotenuto M. Efficacy of Neuro-Psychomotor Approach in Children Affected by Autism Spectrum Disorders: A Multicenter Study in Italian Pediatric Population. Brain Sci. 2021 Sep 14;11(9):1210. doi: 10.3390/brainsci11091210.

  PMID: 34573234 BACKGROUND

• Fandakova Y, Hartley CA. Mechanisms of learning and plasticity in childhood and adolescence. Dev Cogn Neurosci. 2020 Apr;42:100764. doi: 10.1016/j.dcn.2020.100764. Epub 2020 Jan 30. No abstract available.

  PMID: 32072937 BACKGROUND

• Ravi DK, Kumar N, Singhi P. Effectiveness of virtual reality rehabilitation for children and adolescents with cerebral palsy: an updated evidence-based systematic review. Physiotherapy. 2017 Sep;103(3):245-258. doi: 10.1016/j.physio.2016.08.004. Epub 2016 Sep 27.

  PMID: 28109566 BACKGROUND

• De Luca R, Naro A, Colucci PV, Pranio F, Tardiolo G, Billeri L, Le Cause M, De Domenico C, Portaro S, Rao G, Calabro RS. Improvement of brain functional connectivity in autism spectrum disorder: an exploratory study on the potential use of virtual reality. J Neural Transm (Vienna). 2021 Mar;128(3):371-380. doi: 10.1007/s00702-021-02321-3. Epub 2021 Mar 6.

  PMID: 33677622 BACKGROUND

• Harris K, Reid D. The influence of virtual reality play on children's motivation. Can J Occup Ther. 2005 Feb;72(1):21-9. doi: 10.1177/000841740507200107.

  PMID: 15727045 BACKGROUND

• Vasudevan P, Suri M. A clinical approach to developmental delay and intellectual disability. Clin Med (Lond). 2017 Dec;17(6):558-561. doi: 10.7861/clinmedicine.17-6-558.

  PMID: 29196358 BACKGROUND

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Francesca Cucinotta, MD, PhD

CONTACT

09060128256; francesca.cucinotta@irccsme.it

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

CONTACT

info@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 30, 2023
• Study Start: December 1, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

IT (1)