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
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
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
NCT ID
NCT04277130
First Posted
February 12, 2020
Last Updated
February 18, 2020
Sponsor
Hong Kong Baptist University
Collaborators
Research Grants Council, Hong Kong
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
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Effectiveness of Active Video Games in Children With Intellectual Disabilities
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