NCT02486081

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 1, 2019

Status Verified

January 1, 2018

Enrollment Period

3.1 years

First QC Date

June 4, 2015

Last Update Submit

July 31, 2019

Conditions

Keywords

Assistive devicethe disabledspecial educationmovement analysissystem development

Outcome Measures

Primary Outcomes (3)

  • acceleration (in m/sec square)

    one week

  • distance completed (in meters)

    one week

  • time (in second)

    one week

Study Arms (2)

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

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

Device: smart soccer ball

Interventions

smart soccer ball was used to measure participant's performance in total time and distance for completion, and acceleration

children with intelligent disabilitiestypical-developed children (TD)

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children with intellectual disabilities

You may qualify if:

  • 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

You may not qualify if:

  • fracture or receive orthopedic surgery within six months.
  • Participate in regular soccer training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National TaoYuan Special School

Taoyuan District, 300, Taiwan

Location

Chang Gung Univ.

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

July 1, 2015

Study Start

April 1, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

August 1, 2019

Record last verified: 2018-01

Locations