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Wheel Assisted Running Training (WART) in Children With Cerebral Palsy (WART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00946439
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : July 27, 2009
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by:
Israel Sport Center for the Disabled

Tracking Information
First Submitted Date  ICMJE July 24, 2009
First Posted Date  ICMJE July 27, 2009
Last Update Posted Date July 27, 2009
Study Start Date  ICMJE September 2004
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
walking velocity [ Time Frame: six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
Energy expenditure index [ Time Frame: six months ]
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 Wheel Assisted Running Training (WART) in Children With Cerebral Palsy
Official Title  ICMJE Wheel Assisted Running Training in Children With Cerebral Palsy: A Controlled Clinical Trial
Brief Summary

The purpose is to evaluate the effects of adding a wheel assisted running training (WART) to a conventional mixed physical activity training (CT) program on walking and gross motor function in trained children with cerebral palsy (CP).

Method entails recruiting thirty children with CP (16 females, 14 males), with mean (SD) age 11.8 (3.5) and training experience 3.4 (3.5), years were assigned to either WART or CT groups. The energy Expenditure Index (EEI), the Gross Motor Function Measure 66 (GMFM), self-selected and fast walking velocity (SSV and FV, respectively), and cadence are administered by a trained physical therapist. The intervention period is six months, with two sessions per week.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE Device: Wheel assisted running training
'Race-Runner' uses the principle of body weight reduction and wheel assisted running training. This is a three-wheel device specifically designed in the 1990s for athletic purposes. The participant is walking or running with the feet on the ground while using a triangular frame equipped with three large bicycle wheels. Support to the participant's body is provided by a regular cycle saddle, a frontal body support plate, and the steering handlebars. The vertical and horizontal distance of the saddle and frontal support from the steering handlebars are adaptable to the participant's body dimension and comfort. This equipment is commonly used in competition in Scandinavia and Central Europe
Other Name: also called 'Petra'
Study Arms  ICMJE Not Provided
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: July 24, 2009)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • (a) medical diagnosis of cerebral palsy;
  • (b) ability to comprehend instructions in a group setting;
  • (c) no medical procedures involving the lower limbs (including casting and Botox injections) during the last six months prior to pre-testing;
  • (d) able to walk three minutes at a self paced speed;
  • (e) no seizures during the last year, and (f) functional performance levels between II-IV of the gross motor functional classification system (GMFCS)

Exclusion Criteria:

  • (a) GMFCS I or V;
  • (b) Not being able to comprehend or comply with instructions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00946439
Other Study ID Numbers  ICMJE Revital123
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Ziva Yizhar, Dept. Physical Therapy Faculty of Medicine Tel Aviv University
Study Sponsor  ICMJE Israel Sport Center for the Disabled
Collaborators  ICMJE Tel-Aviv Sourasky Medical Center
Investigators  ICMJE
Study Director: Yeshayahu Hutzler, Ph.D Israel Sport Center for the Disabled
PRS Account Israel Sport Center for the Disabled
Verification Date July 2009

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