search
Back to results

Effectiveness of Active Video Games in Children With Intellectual Disabilities

Primary Purpose

Intellectual Disability

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention with active video games
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intellectual Disability focused on measuring exergame, children with intellectual disability, physical activity, motor proficiency

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • students with ID (mild category) aged 8-18 years old from special education schools including primary and secondary schools;

Exclusion Criteria:

  • students without physical disability.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    Intervention with active video games

    No intervention

    Outcomes

    Primary Outcome Measures

    Change of body mass index
    Weight (measured in kilograms) and height (measured in meters) are combined to report body mass index in kg/m^2. Change of body mass index between baseline and post-intervention test is assessed.
    Change of body fat percentage
    Body fat percentage is measured using the Tanita BC-418 Body Composition Analyzer at baseline and post-intervention test and is reported the unit as %. Change of body fat percentage between baseline and post-intervention test is assessed.
    Change of sedentary behavior time
    Objective physical activity level was recorded and measured using the ActiGraph GT3X+ activity monitor (Pensacola, FL). Counts per minute are recorded. The activity with lower than 100 counts per minute is categorized as sedentary behaviors. Overall time in sedentary behavior in minute is recorded as sedentary behavior time. Change of sedentary behavior time between baseline and post-intervention tests is assessed.
    Change of light physical activity time
    Objective physical activity level was recorded and measured using the ActiGraph GT3X+ activity monitor (Pensacola, FL). Counts per minute are recorded. The activity with higher than 100 counts per minute but lower than 2296 counts per minute is categorized as light physical activity. Overall time in light physical activity in minute is recorded as light physical activity time. Change of light physical activity time between baseline and post-intervention tests is assessed.
    Change of moderate-to-vigorous physical activity time
    Objective physical activity level was recorded and measured using the ActiGraph GT3X+ activity monitor (Pensacola, FL). Counts per minute are recorded. The activity with higher than 2296 counts per minute is categorized as moderate-to-vigorous physical activity. Overall time in moderate-to-vigorous physical activity in minute is recorded as moderate-to-vigorous physical activity time. Change of moderate-to-vigorous physical activity time between baseline and post-intervention tests is assessed.
    Change of motor proficiency
    The short-form Bruininks-Oseretsky Test of Motor Proficiency™ - Second Edition (BOT-2) (Bruininks & Bruininks, 2005) is used for the assessment of motor proficiency. The scale consists of 14 items and scored 0-88. Higher score indicates higher motor proficiency. Change of BOT-2 score between baseline and post-intervention tests is assessed.
    Change of muscular strength
    The hand dynamometer (Model 01160, Lafayette Instrument Company, Lafayette, Indiana, USA) is used to measure the muscular strength. Output is in kilograms (range 0.0-199.9kg with sensitivity at 0.1kg). The change of muscular strength between baseline and post-intervention tests is assessed.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 12, 2020
    Last Updated
    February 18, 2020
    Sponsor
    Hong Kong Baptist University
    Collaborators
    Research Grants Council, Hong Kong
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04277130
    Brief Title
    Effectiveness of Active Video Games in Children With Intellectual Disabilities
    Official Title
    Intervention Study of Active Video Games on Intellectual Disabled Children's Physical Activity Level, Motor Ability and Physical Fitness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    January 31, 2018 (Actual)
    Study Completion Date
    August 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hong Kong Baptist University
    Collaborators
    Research Grants Council, Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Background: Children with intellectual disabilities (ID) are more vulnerable to obesity when compared to the normal children (Getchell et al., 2012; Maiano, 2011). Active video games (AVGs) on physical activity (PA) behavior have attracted academic interest and exploration since 2000. It has been demonstrated that an intervention with AVGs is compatible with the school setting and behavioral change in health and PA (Lau, et al., 2015). However, special populations such as ID children and their needs have been neglected in this area (Martins, Carvalho & Soares, 2011). ID children's PA behavior, motor ability and physical fitness is still an under-explored area. Aims: To determine the effect of a prescribed AVG intervention on ID children's PA levels (sedentary, light, moderate, and vigorous), motor ability, and physical fitness. The intervention effects in children with mild intellectual disability will be explored. Design: A standard two-arm parallel, single-blinded, randomized control cluster trial. Schools: Participants will be recruited from six special schools in Hong Kong. Schools with same intellectual disability categories will be randomly assigned into intervention group and control group. Participants: 200 Children aged 8~18 years old with intellectual disabilities will be recruited. Intervention: ID children randomized to the intervention group will participate in an AVG intervention 60 minutes per week for 12 weeks in their PE class, in addition to their usual activity levels. The research team will prescribe updated AVG consistent with moderate-vigorous intensity. Control: The control group will continue with usual PA alone and will not receive the AVG intervention. Analysis: Repeated measures mixed model (2 groups X 2 time points (12-week post- test and 8-week follow up test)) by SPSS 23.0 will be used to investigate the intervention effect on primary and secondary outcomes, adjusting for baseline characteristics and correlation between repeated observations. Significance: This will be the pioneering study to provide definitive evidence for the impact of a prescribed AVG intervention on ID children's PA level, motor ability and physical fitness. If effective, this research will provide significant evidence from the innovative method to inform health professionals and PE teachers how to incorporate AVG to enhance physical active behaviors, motor ability and physical fitness in ID children. Finally they may be able to enjoy a better quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intellectual Disability
    Keywords
    exergame, children with intellectual disability, physical activity, motor proficiency

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    203 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Intervention with active video games
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intervention with active video games
    Intervention Description
    Participants in intervention group were paired up by their teachers. Each participant had a classmate playing with him/her, and the waiting time is minimal because Xbox 360 Kinect allowed double play mode. The intervention group was provided with an AVG, the Xbox 360 Kinect technology (Kinect Sports Seasons I & II, including bowling, soccer, boxing, track and field, table tennis, beach volleyball, golf, tennis). The AVG intervention consisted of two 30-min sessions per week, for a total of 12 weeks. Participants either played in PE classes and/or recess. They had no other specific routing of activities but straight played the AVG during the intervention. They could free to choose games they like in the Xbox 360. The AVGs of Xbox 360 chosen was of moderate to vigorous intensity (3-6 METs) and no matter what games they chose, their PA level would be between moderate and vigorous intensity.
    Primary Outcome Measure Information:
    Title
    Change of body mass index
    Description
    Weight (measured in kilograms) and height (measured in meters) are combined to report body mass index in kg/m^2. Change of body mass index between baseline and post-intervention test is assessed.
    Time Frame
    through study completion, 12 weeks
    Title
    Change of body fat percentage
    Description
    Body fat percentage is measured using the Tanita BC-418 Body Composition Analyzer at baseline and post-intervention test and is reported the unit as %. Change of body fat percentage between baseline and post-intervention test is assessed.
    Time Frame
    through study completion, 12 weeks
    Title
    Change of sedentary behavior time
    Description
    Objective physical activity level was recorded and measured using the ActiGraph GT3X+ activity monitor (Pensacola, FL). Counts per minute are recorded. The activity with lower than 100 counts per minute is categorized as sedentary behaviors. Overall time in sedentary behavior in minute is recorded as sedentary behavior time. Change of sedentary behavior time between baseline and post-intervention tests is assessed.
    Time Frame
    through study completion, 12 weeks
    Title
    Change of light physical activity time
    Description
    Objective physical activity level was recorded and measured using the ActiGraph GT3X+ activity monitor (Pensacola, FL). Counts per minute are recorded. The activity with higher than 100 counts per minute but lower than 2296 counts per minute is categorized as light physical activity. Overall time in light physical activity in minute is recorded as light physical activity time. Change of light physical activity time between baseline and post-intervention tests is assessed.
    Time Frame
    through study completion, 12 weeks
    Title
    Change of moderate-to-vigorous physical activity time
    Description
    Objective physical activity level was recorded and measured using the ActiGraph GT3X+ activity monitor (Pensacola, FL). Counts per minute are recorded. The activity with higher than 2296 counts per minute is categorized as moderate-to-vigorous physical activity. Overall time in moderate-to-vigorous physical activity in minute is recorded as moderate-to-vigorous physical activity time. Change of moderate-to-vigorous physical activity time between baseline and post-intervention tests is assessed.
    Time Frame
    through study completion, 12 weeks
    Title
    Change of motor proficiency
    Description
    The short-form Bruininks-Oseretsky Test of Motor Proficiency™ - Second Edition (BOT-2) (Bruininks & Bruininks, 2005) is used for the assessment of motor proficiency. The scale consists of 14 items and scored 0-88. Higher score indicates higher motor proficiency. Change of BOT-2 score between baseline and post-intervention tests is assessed.
    Time Frame
    through study completion, 12 weeks
    Title
    Change of muscular strength
    Description
    The hand dynamometer (Model 01160, Lafayette Instrument Company, Lafayette, Indiana, USA) is used to measure the muscular strength. Output is in kilograms (range 0.0-199.9kg with sensitivity at 0.1kg). The change of muscular strength between baseline and post-intervention tests is assessed.
    Time Frame
    through study completion, 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: students with ID (mild category) aged 8-18 years old from special education schools including primary and secondary schools; Exclusion Criteria: students without physical disability.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wing-Chung Lau, Ph.D
    Organizational Affiliation
    Hong Kong Baptist University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effectiveness of Active Video Games in Children With Intellectual Disabilities

    We'll reach out to this number within 24 hrs