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

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: Wheel assisted running training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Wheel Assisted Running Training in Children With Cerebral Palsy: A Controlled Clinical Trial
Study Start Date : September 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

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Arms and Interventions
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Intervention Details:
  • 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'

Outcome Measures
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Primary Outcome Measures :
  1. walking velocity [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Energy expenditure index [ Time Frame: six months ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946439


Locations
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Israel
Israel Sport Center for the Disabled
Ramat Gan, Israel, 52535
Sponsors and Collaborators
Israel Sport Center for the Disabled
Tel-Aviv Sourasky Medical Center
Investigators
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Study Director: Yeshayahu Hutzler, Ph.D Israel Sport Center for the Disabled
More Information
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Responsible Party: Dr. Ziva Yizhar, Dept. Physical Therapy Faculty of Medicine Tel Aviv University
ClinicalTrials.gov Identifier: NCT00946439    
Other Study ID Numbers: Revital123
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: July 27, 2009
Last Verified: July 2009
Keywords provided by Israel Sport Center for the Disabled:
training exercise gait
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases