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

• ClinicalTrials.gov Identifier: NCT00946439
• Recruitment Status: Completed
• First Posted: July 27, 2009
• Last Update Posted: July 27, 2009
• Sponsor: Israel Sport Center for the Disabled
• Collaborator: Tel-Aviv Sourasky Medical Center
• Information provided by: Israel Sport Center for the Disabled

Tracking Information

• First Submitted Date: July 24, 2009
• First Posted Date: July 27, 2009
• Last Update Posted Date: July 27, 2009
• Study Start Date: September 2004
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 24, 2009): walking velocity [ Time Frame: six months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: July 24, 2009): Energy expenditure index [ Time Frame: six months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Wheel Assisted Running Training (WART) in Children With Cerebral Palsy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Single (Care Provider); Primary Purpose: Treatment
• Condition: Cerebral Palsy

Intervention

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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 24, 2009): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2006
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00946439
• Other Study ID Numbers: Revital123
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Ziva Yizhar, Dept. Physical Therapy Faculty of Medicine Tel Aviv University
• Study Sponsor: Israel Sport Center for the Disabled
• Collaborators: Tel-Aviv Sourasky Medical Center

Investigators

• Study Director: Yeshayahu Hutzler, Ph.D; Israel Sport Center for the Disabled

• PRS Account: Israel Sport Center for the Disabled
• Verification Date: July 2009