Developmental DelaysPhase 4NCT02184715
Effects of Virtual Reality System in Children With Developmental Delays
A Phase 4 study testing virtual reality system in people with Developmental Delays, run by Ru-Lan Hsieh at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the effects of virtual reality system on children with developmental delays. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Developmental Delays
- What is being tested?
- virtual reality system
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 4
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- confirmed to have developmental delays
- provided informed consent
- 2 to 12 years old
Who cannot join
- failed to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Additional Therapeutic Effects of Virtual Reality System in Children With Developmental Delays
The purpose of this study is to investigate the effects of virtual reality system on children with developmental delays.
Read the detailed description
Participants attended eight 30-minute sessions of virtual reality system for 4 weeks in addition to regular rehabilitation programs.
- Conditions
- Developmental Delays
- Being tested
- virtual reality system
- Keywords
- virtual reality system, children, developmental delay
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality systemOther
The participants were randomly assigned to either Group A or Group B. Group A received rehabilitation treatment and additional virtual reality system for 1 month, followed by rehabilitation treatment for 1 month; by contrast, the participants in Group B received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality video game | Active comparator | Participants received rehabilitation treatment and additional virtual reality system (30 minutes of interactive virtual reality system play, two times per week, in eight sessions over a 4-week span) for 1 month, followed by rehabilitation treatment for 1 month Receives: Other: virtual reality system |
| Virtual reality system | Placebo comparator | received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system (30 minutes of interactive video game play, two times per week, in eight sessions over a 4-week span) during the one month of intervention period. Receives: Other: virtual reality system |
What is being measured
The primary outcome is the main question the study is designed to answer.
health of children (Pediatric Quality of Life Inventory)
Following the recruitment and baseline assessment, outcome measures were assessed before treatment (Time 0), at the end of first intervention in the fourth week (Time 1), and at the end of second intervention in the eighth week (Time 2).
Measured: changes from baseline at one and two months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DelaysStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ru-Lan Hsieh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184715
- Sponsor's protocol ID
- HP-01
- Status last verified
- Jul 2014
- First submitted
- 3 Jul 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hsieh RL, Lee WC, Lin JH. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial. PLoS One. 2016 Mar 16;11(3):e0149714. doi: 10.1371/journal.pone.0149714. eCollection 2016.
PubMed 26983099
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Additional Therapeutic Effects of Virtual Reality System in Children With Developmental Delays
- ClinicalTrials.gov ID
- NCT02184715
- Acronym / sponsor ID
- HP-01
- Conditions
- Developmental Delays
- Keywords
- virtual reality system, children, developmental delay
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Ru-Lan HsiehUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Jul 2014 (estimated)
- 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.
The purpose of this study is to investigate the effects of virtual reality system on children with developmental delays.
Detailed description
Participants attended eight 30-minute sessions of virtual reality system for 4 weeks in addition to regular rehabilitation programs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality video game | Active comparator | Other: virtual reality systemParticipants received rehabilitation treatment and additional virtual reality system (30 minutes of interactive virtual reality system play, two times per week, in eight sessions over a 4-week span) for 1 month, followed by rehabilitation treatment for 1 month |
| Virtual reality system | Placebo comparator | Other: virtual reality systemreceived rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system (30 minutes of interactive video game play, two times per week, in eight sessions over a 4-week span) during the one month of intervention period. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- confirmed to have developmental delays
- provided informed consent
- 2 to 12 years old
Key exclusion criteria (1 listed)
- failed to provide informed consent
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 |
|---|---|---|
| virtual reality systemThe participants were randomly assigned to either Group A or Group B. Group A received rehabilitation treatment and additional virtual reality system for 1 month, followed by rehabilitation treatment for 1 month; by contrast, the participants in Group B received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system for 1 month. | Other | Virtual reality system, Virtual reality video game |
Primary outcome
health of children (Pediatric Quality of Life Inventory)
Time frame: changes from baseline at one and two months.
Following the recruitment and baseline assessment, outcome measures were assessed before treatment (Time 0), at the end of first intervention in the fourth week (Time 1), and at the end of second intervention in the eighth week (Time 2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Derived from this study: PubMed 26983099Hsieh RL, Lee WC, Lin JH. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial. PLoS One. 2016 Mar 16;11(3):e0149714. doi: 10.1371/journal.pone.0149714. eCollection 2016.
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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.
Ru-Lan Hsieh, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing virtual reality system in people with Developmental Delays, run by Ru-Lan Hsieh at 1 site in Taiwan.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 9 Jul 2014. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health of children (Pediatric Quality of Life Inventory) (time frame: changes from baseline at one and two months.). 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 NCT02184715, which also lists 1 linked publication.
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 9 Jul 2014.