Effects of Virtual Reality System in Children With Developmental Delays

NCT ID: NCT02184715

Last Updated: 2014-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to investigate the effects of virtual reality system on children with developmental delays.

Detailed Description

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Participants attended eight 30-minute sessions of virtual reality system for 4 weeks in addition to regular rehabilitation programs.

Conditions

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Developmental Delays

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Virtual reality video game

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

Group Type ACTIVE_COMPARATOR

virtual reality system

Intervention Type OTHER

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.

Virtual reality system

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.

Group Type PLACEBO_COMPARATOR

virtual reality system

Intervention Type OTHER

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.

Interventions

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virtual reality system

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* confirmed to have developmental delays
* provided informed consent
* 2 to 12 years old

Exclusion Criteria

* failed to provide informed consent
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ru-Lan Hsieh

OTHER

Sponsor Role lead

Responsible Party

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Ru-Lan Hsieh

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ru-Lan Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 26983099 (View on PubMed)

Other Identifiers

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HP-01

Identifier Type: -

Identifier Source: org_study_id

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