Intellectual DisabilityNCT02486081
Development and Application-Smart Football for Movement Evaluation and Training in the Special Education Population
An observational study of Intellectual Disability, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
Children with disabilities are frequently ignored by the general population, hence the development of movement evaluation and training devices for use in special education settings are relatively overlooked. Usually the performance of these children is not stable and contains variations. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- smart soccer ball
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesTaiwan
- Study dates
- Apr 2016to May 2019
- Phase
- Observational
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children with intellectual disabilities
Who may be able to join
- Intellectual disabilities (ID) group:
- children with mild to moderate intellectual disabilities.
- able to walk independently
- can follow simple commands
- Typical developed children:
- age-matched TD children
Who cannot join
- fracture or receive orthopedic surgery within six months.
- Participate in regular soccer training.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National TaoYuan Special School
Taoyuan, 300
Chang Gung Univ.
Taoyuan, 333
About this study
Official title: Assistive Device Design, Development and Application-Smart Football for Movement Evaluation and Training in the Special Education Population
Children with disabilities are frequently ignored by the general population, hence the development of movement evaluation and training devices for use in special education settings are relatively overlooked. Usually the performance of these children is not stable and contains variations. Hence in order to get a complete picture of their sport performance, simply measuring movement time and distance is definitely not representative. With the rising attention from government regarding fitness and social participation of the disabled in recent years, developing a special-designed individual evaluation \& training plan is of great importance. To achieve this goal, a device which is able to record the complete process of movement, and contains algorithm that can pick up the movement characteristics of children with disabilities is needed. The purpose of this study is to design and develop a smart soccer ball system for use in children with intellectual disabilities(ID), and to compare the performance between children with ID and the typically developed.
- Conditions
- Intellectual Disability
- Being tested
- smart soccer ball
- Keywords
- Assistive device, the disabled, special education, movement analysis, system development
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart soccer ballDevice
smart soccer ball was used to measure participant's performance in total time and distance for completion, and acceleration
| Study group | Role | What they receive |
|---|---|---|
| children with intelligent disabilities | children with ID will be measured via a smart soccer ball. Performance will be measured as acceleration, total time for completion, total distance Receives: Device: smart soccer ball | |
| typical-developed children (TD) | TD children will be measured via a smart soccer ball. Performance will be measured as acceleration, total time for completion, total distance Receives: Device: smart soccer ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceleration (in m/sec square)
Measured: one week
distance completed (in meters)
Measured: one week
time (in second)
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startApr 2016
- Primary completionMay 2019
- Study completionMay 2019
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486081
- Sponsor's protocol ID
- 103-7262B
- Status last verified
- Jan 2018
- First submitted
- 4 Jun 2015
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistive Device Design, Development and Application-Smart Football for Movement Evaluation and Training in the Special Education Population
- ClinicalTrials.gov ID
- NCT02486081
- Acronym / sponsor ID
- 103-7262B
- Conditions
- Intellectual Disability
- Keywords
- Assistive device, the disabled, special education, movement analysis, system development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 1 Jul 2015 (estimated)
- 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.
Children with disabilities are frequently ignored by the general population, hence the development of movement evaluation and training devices for use in special education settings are relatively overlooked. Usually the performance of these children is not stable and contains variations. Hence in order to get a complete picture of their sport performance, simply measuring movement time and distance is definitely not representative. With the rising attention from government regarding fitness and social participation of the disabled in recent years, developing a special-designed individual evaluation \& training plan is of great importance. To achieve this goal, a device which is able to record the complete process of movement, and contains algorithm that can pick up the movement characteristics of children with disabilities is needed. The purpose of this study is to design and develop a smart soccer ball system for use in children with intellectual disabilities(ID), and to compare the performance between children with ID and the typically developed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with intelligent disabilities | – | Device: smart soccer ballchildren with ID will be measured via a smart soccer ball. Performance will be measured as acceleration, total time for completion, total distance |
| typical-developed children (TD) | – | Device: smart soccer ballTD children will be measured via a smart soccer ball. Performance will be measured as acceleration, total time for completion, total distance |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children with intellectual disabilities
Key inclusion criteria (6 listed)
- Intellectual disabilities (ID) group:
- Typical developed children:
Key exclusion criteria (2 listed)
- fracture or receive orthopedic surgery within six months.
- Participate in regular soccer training.
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 |
|---|---|---|
| smart soccer ballsmart soccer ball was used to measure participant's performance in total time and distance for completion, and acceleration | Device | children with intelligent disabilities, typical-developed children (TD) |
Primary outcome
acceleration (in m/sec square)
Time frame: one week
distance completed (in meters)
Time frame: one week
time (in second)
Time frame: one week
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 1 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
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 6 inclusion and 2 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
acceleration (in m/sec square) (time frame: one week). The study lists 3 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 1 Aug 2019.