Intellectual DisabilityNCT04277130
Effectiveness of Active Video Games in Children With Intellectual Disabilities
A study testing Intervention with active video games in people with Intellectual Disability, run by Hong Kong Baptist University.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Intervention with active video games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 31 Aug 2018
- Phase
- Interventional
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- students with ID (mild category) aged 8-18 years old from special education schools including primary and secondary schools;
Who cannot join
- students without physical disability.
About this study
Official title: Intervention Study of Active Video Games on Intellectual Disabled Children's Physical Activity Level, Motor Ability and Physical Fitness
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.
Read more
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.
- Conditions
- Intellectual Disability
- Being tested
- Intervention with active video games
- Keywords
- exergame, children with intellectual disability, physical activity, motor proficiency
- Medical subject headings
- Intellectual Disability, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with active video gamesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention with active video games Receives: Behavioral: Intervention with active video games |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, 12 weeks
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.
Measured: through study completion, 12 weeks
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.
Measured: through study completion, 12 weeks
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.
Measured: through study completion, 12 weeks
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.
Measured: through study completion, 12 weeks
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.
Measured: through study completion, 12 weeks
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.
Measured: through study completion, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Sep 2016
- Primary completion31 Jan 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Responsible party
- Principal investigator, Lau Wing Chung, Hong Kong Baptist University
- Investigators
- Wing-Chung Lau, Ph.D, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277130
- Sponsor's protocol ID
- HASC/15-16/0169
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study of Active Video Games on Intellectual Disabled Children's Physical Activity Level, Motor Ability and Physical Fitness
- ClinicalTrials.gov ID
- NCT04277130
- Acronym / sponsor ID
- HASC/15-16/0169
- Conditions
- Intellectual Disability
- Keywords
- exergame, children with intellectual disability, physical activity, motor proficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 20 Feb 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention with active video gamesIntervention with active video games |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- students with ID (mild category) aged 8-18 years old from special education schools including primary and secondary schools;
Key exclusion criteria (1 listed)
- students without physical disability.
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 |
|---|---|---|
| Intervention with active video gamesParticipants 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. | Behavioural | Intervention group |
Primary outcome
Change of body mass index
Time frame: through study completion, 12 weeks
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
Time frame: through study completion, 12 weeks
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
Time frame: through study completion, 12 weeks
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
Time frame: through study completion, 12 weeks
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
Time frame: through study completion, 12 weeks
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
Time frame: through study completion, 12 weeks
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
Time frame: through study completion, 12 weeks
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.
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 20 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Wing-Chung Lau, Ph.D principal investigator
Hong Kong Baptist University
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with active video games in people with Intellectual Disability, run by Hong Kong Baptist University.
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 1 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change of body mass index (time frame: through study completion, 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2020.