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

This study has been completed.
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by:
Israel Sport Center for the Disabled
ClinicalTrials.gov Identifier:
NCT00946439
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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 Intervention
Cerebral Palsy
 Device: Wheel assisted running training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Wheel Assisted Running Training in Children With Cerebral Palsy: A Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Israel Sport Center for the Disabled:

Primary Outcome Measures:
  • walking velocity [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Energy expenditure index [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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'
  Eligibility

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946439

Locations
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
Study Director: Yeshayahu Hutzler, Ph.D Israel Sport Center for the Disabled
  More Information

No publications provided

Responsible Party: Dr. Ziva Yizhar, Dept. Physical Therapy Faculty of Medicine Tel Aviv University
ClinicalTrials.gov Identifier: NCT00946439     History of Changes
Other Study ID Numbers: Revital123
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Israel Sport Center for the Disabled:
training exercise gait

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013