Global Developmental DelayNCT05879952
Virtual Reality and Neuropsychiatric Rehabilitation in Patients With Global Developmental Delay.
A study testing TAU + BTsN session and TAU in people with Global Developmental Delay, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 66 months
- Conditions the study is for
- Global Developmental Delay
- What is being tested?
- TAU + BTsN session and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 66 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
IRCCS Centro Neurolesi Bonino Pulejo Bio-parco delle intelligenze e delle Neurofragilità contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neurolesi Bonino Pulejo
Messina, 98124
Francesca Cucinotta, PhD, 09060128256, francesca.cucinotta@irccsme.it
Carmela Settimo
About this study
Official title: Virtual Reality and Neuropsychiatric Rehabilitation: a Single-blind, Randomized, Controlled Pilot Study in Patients With Global Developmental Delay.
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.
Read the 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
- Being tested
- TAU + BTsN session, TAU
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU + BTsN sessionBehavioural
Also called standard neuro-psychomotor training + virtual reality game sessions
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.
TAUBehavioural
Also called neuro-psychomotor training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: T0 (Baseline) - T1 (6 Months)
Secondary outcomes (1)
The Child Behavior Checklist (CBCL 1½-5)
This questionnarie is a caregiver report to identifying problem behavior in children.
Measured: T0 (Baseline) - T1 (6 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Dec 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Global Developmental DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Cucinotta, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879952
- Sponsor's protocol ID
- Nir01
- Status last verified
- Jun 2023
- First submitted
- 19 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16818559Alderman 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/
PubMed 30212122Thomaidis 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.
PubMed 24521451Caliendo 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.
PubMed 34573234Fandakova 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.
PubMed 32072937Ravi 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.
PubMed 28109566De 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.
PubMed 33677622Harris 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.
PubMed 15727045Vasudevan 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.
PubMed 29196358
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Neuropsychiatric Rehabilitation: a Single-blind, Randomized, Controlled Pilot Study in Patients With Global Developmental Delay.
- ClinicalTrials.gov ID
- NCT05879952
- Acronym / sponsor ID
- Nir01
- Conditions
- Global Developmental Delay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Behavioral: TAU + BTsN sessionThe 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. |
| Control Group (CG) | Active comparator | Behavioral: TAUThe 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. |
Who may qualify
- Ages
- 12 to 66 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAU + BTsN sessionAlso: standard neuro-psychomotor training + virtual reality game sessionsBTsN 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. | Behavioural | Experimental Group (EG) |
| TAUAlso: neuro-psychomotor trainingneuro-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. | Behavioural | Control Group (CG) |
Primary outcome
Griffiths-III Mental Development Scale (GMDS-III)
Time frame: 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)
Time frame: 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 adherence
Time frame: 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.
1 secondary outcome
The Child Behavior Checklist (CBCL 1½-5)
Time frame: T0 (Baseline) - T1 (6 Months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Background: PubMed 16818559Srour 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.
- Background: PubMed 30212122Alderman 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/
- Background: PubMed 24521451Thomaidis 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.
- Background: PubMed 34573234Caliendo 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.
- Background: PubMed 32072937Fandakova 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.
- Background: PubMed 28109566Ravi 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.
- Background: PubMed 33677622De 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.
- Background: PubMed 15727045Harris 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.
- Background: PubMed 29196358Vasudevan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IRCCS Centro Neurolesi Bonino Pulejo Bio-parco delle intelligenze e delle Neurofragilità contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAU + BTsN session and TAU in people with Global Developmental Delay, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca Cucinotta, MD, PhD (09060128256, francesca.cucinotta@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Griffiths-III Mental Development Scale (GMDS-III) (time frame: T0 (Baseline) - T1 (6 Months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05879952, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.