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Fitball Program Versus Task-oriented Motor Program on Improving Postural Control in Developmental Coordination Disorder

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ClinicalTrials.gov Identifier: NCT01207544
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : November 28, 2012
Sponsor:
Collaborator:
Kowloon Hospital, Hong Kong
Information provided by (Responsible Party):
Marco Yiu-Chung Pang, The Hong Kong Polytechnic University

Tracking Information
First Submitted Date  ICMJE September 22, 2010
First Posted Date  ICMJE September 23, 2010
Last Update Posted Date November 28, 2012
Study Start Date  ICMJE April 2010
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2010)
  • Brunininks-Oseretsky Test of Motor Proficiency II [ Time Frame: Week 0 ]
    Brunininks-Oseretsky Test of Motor Proficiency II is a tool for assessing motor skills.
  • Brunininks-Oseretsky Test of Motor Proficiency II [ Time Frame: Week 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01207544 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2010)
  • Sensory Organization Test (SOT) [ Time Frame: Week 0 ]
    SOT is a tool for measuring postural stability.
  • Sensory Organization Test (SOT) [ Time Frame: Week 8 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fitball Program Versus Task-oriented Motor Program on Improving Postural Control in Developmental Coordination Disorder
Official Title  ICMJE The Effectiveness of Fitball Program Versus Task-oriented Motor Program on Improving Postural Control and Motor Proficiency in Children With Developmental Coordination Disorder
Brief Summary Children with developmental coordination disorder (DCD) often have poor postural control and motor skills that affect their activities of daily living and participation in school activities. The aim of this randomized controlled trial is to compare the effects of fitball training versus task-oriented motor training for children with DCD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Developmental Coordination Disorder
Intervention  ICMJE
  • Behavioral: Fitball exercise
    Supervised fitball exercise program session (1 hour per session, 1 session per week, for 8 consecutive weeks), supplemented by daily home exercise program.
  • Behavioral: task-oriented motor training program
    Task-oriented motor exercise program session (1 hour per session, 1 session per week, for 8 consecutive weeks), supplemented by daily home exercise program.
Study Arms  ICMJE
  • Experimental: fitball program
    This group will undergo the fitball program consisting of a supervised exercise session once per week for 8 weeks, supplemented by home exercises. The exercise session will be conducted by a qualified physiotherapist.
    Intervention: Behavioral: Fitball exercise
  • Active Comparator: Task-oriented program
    This group will undergo the task-oriented motor training program consisting of a supervised exercise session once per week for 8 weeks, supplemented by home exercises. The exercise session will be conducted by a qualified physiotherapist.
    Intervention: Behavioral: task-oriented motor training program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2012)
22
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2010)
50
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosis of DCD according to DSM-IV criteria
  • Poor motor skills (Movement Assessment Battery for Children score <15 percentile, or any two or more of subtests in BOT II < 1.5 SD)
  • aged between 6-12 years old

Exclusion Criteria:

  • have attended treatment for motor problems in the previous 6 months
  • any major co-morbid medical / neurological / sensory problems such as moderate to severe mental disability, profound visual or hearing impairment, severe sensory problems, or had any major behavioral problems.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01207544
Other Study ID Numbers  ICMJE HSEARS2009113001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
Study Sponsor  ICMJE The Hong Kong Polytechnic University
Collaborators  ICMJE Kowloon Hospital, Hong Kong
Investigators  ICMJE
Principal Investigator: Marco YC Pang, PhD The Hong Kong Polytechnic University
PRS Account The Hong Kong Polytechnic University
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP