Effects of Virtual Reality System in Children With Developmental Delays

NCT02184715 | Completed Phase 4

• 1 other identifier: HP-01
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Developmental Delays

Keywords

virtual reality system, children, developmental delay

Outcome Measures

Primary Outcomes (1)

• 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).

  changes from baseline at one and two months.

Study Arms (2)

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

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.

Other: virtual reality system

Interventions

virtual reality system 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; Virtual reality video game

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• confirmed to have developmental delays
• provided informed consent
• to 12 years old

You may not qualify if:

• failed to provide informed consent

Sponsors & Collaborators

• Ru-Lan Hsieh: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 26983099 DERIVED

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

Study Officials

• Ru-Lan Hsieh, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

TW (1)