Wheel Assisted Running Training (WART) in Children With Cerebral Palsy (WART)
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Wheel assisted running training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring training exercise gait
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.
Sites / Locations
- Israel Sport Center for the Disabled
Outcomes
Primary Outcome Measures
walking velocity
Secondary Outcome Measures
Energy expenditure index
Full Information
NCT ID
NCT00946439
First Posted
July 24, 2009
Last Updated
July 24, 2009
Sponsor
Israel Sport Center for the Disabled
Collaborators
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00946439
Brief Title
Wheel Assisted Running Training (WART) in Children With Cerebral Palsy
Acronym
WART
Official Title
Wheel Assisted Running Training in Children With Cerebral Palsy: A Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Israel Sport Center for the Disabled
Collaborators
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
training exercise gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Wheel assisted running training
Other Intervention Name(s)
also called 'Petra'
Intervention Description
'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
Primary Outcome Measure Information:
Title
walking velocity
Time Frame
six months
Secondary Outcome Measure Information:
Title
Energy expenditure index
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeshayahu Hutzler, Ph.D
Organizational Affiliation
Israel Sport Center for the Disabled
Official's Role
Study Director
Facility Information:
Facility Name
Israel Sport Center for the Disabled
City
Ramat Gan
ZIP/Postal Code
52535
Country
Israel
12. IPD Sharing Statement
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Wheel Assisted Running Training (WART) in Children With Cerebral Palsy
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