Study of a Stationary Cycling Intervention for Children With Spastic Diplegic Cerebral Palsy (PEDALS)
![]() |
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: NCT00401154 |
Recruitment Status
:
Completed
First Posted
: November 17, 2006
Last Update Posted
: December 8, 2014
|
Sponsor:
University of Southern California
Collaborator:
Physical Therapy Clinical Research Network
Information provided by (Responsible Party):
Sharon K. DeMuth, University of Southern California
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | November 15, 2006 | |||
First Posted Date ICMJE | November 17, 2006 | |||
Last Update Posted Date | December 8, 2014 | |||
Study Start Date ICMJE | September 2003 | |||
Actual Primary Completion Date | March 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
|
|||
Change History | Complete list of historical versions of study NCT00401154 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Gait Analysis will be performed on a subset of the children enrolled. [ Time Frame: Basline and Post Intervention ] Analyses changes in walking
|
|||
Original Secondary Outcome Measures ICMJE |
Gait Analysis will be performed on a subset of the children enrolled. | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of a Stationary Cycling Intervention for Children With Spastic Diplegic Cerebral Palsy | |||
Official Title ICMJE | Pediatric Endurance and Limb Strengthening (PEDALS) | |||
Brief Summary | The study is about the effect of an exercise program using stationary bicycling for children with the spastic diplegic form of cerebral palsy. Spastic diplegia is a type of cerebral palsy that involves spasticity or "tightness" of the leg muscles. We hope to learn whether this type of exercise will allow the children to develop improved strength in the muscles that bend and straighten their knees, enhance their level of physical fitness, improve their ability to walk and improve their ability to perform other activities that are important to them. We hypothesize that children who participate in the stationary cycling intervention will gain strength in the muscles that bend and straighten their knees, will be able to complete a 600 yard walk run test (a test of endurance) more rapidly, and will improve their score on a test of function called the Gross Motor Function Measure (a test designed specifically for children with cerebral palsy). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
|||
Condition ICMJE | Spastic Diplegic Cerebral Palsy | |||
Intervention ICMJE | Other: Stationary Cycling
Use of a stationary bicycle for exercise |
|||
Study Arms | Experimental: Intervention Stationary Cycling
Subjects receiving the intervention performed stationary cycling 3 times a week for 30 sessions over 12 weeks.
Intervention: Other: Stationary Cycling |
|||
Publications * |
|
|||
* 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 |
64 | |||
Original Enrollment ICMJE |
60 | |||
Actual Study Completion Date | March 2006 | |||
Actual Primary Completion Date | March 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 7 Years to 18 Years (Child, Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00401154 | |||
Other Study ID Numbers ICMJE | HS-025023-CR001 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Sharon K. DeMuth, University of Southern California | |||
Study Sponsor ICMJE | University of Southern California | |||
Collaborators ICMJE | Physical Therapy Clinical Research Network | |||
Investigators ICMJE |
|
|||
PRS Account | University of Southern California | |||
Verification Date | December 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |