Study of a Stationary Cycling Intervention for Children With Spastic Diplegic Cerebral Palsy (PEDALS)
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|ClinicalTrials.gov Identifier: NCT00401154|
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : December 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Spastic Diplegic Cerebral Palsy||Other: Stationary Cycling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Pediatric Endurance and Limb Strengthening (PEDALS)|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
Experimental: Intervention Stationary Cycling
Subjects receiving the intervention performed stationary cycling 3 times a week for 30 sessions over 12 weeks.
Other: Stationary Cycling
Use of a stationary bicycle for exercise
- Gross Motor Function Measure-66 (GMFM) [ Time Frame: Basline and Post Intervention ]Describes gross motor function in children with cerebral palsy.
- 600 Yard Walk-Run Test [ Time Frame: Baseline and Post Intervention ]Timed test to show how rapidly the subject can walk or run 600 yards.
- 30 Second Walk Test [ Time Frame: Basline and Post Intervention ]Timed test to measure the distance a subject walks in 30 seconds.
- Knee Flexor and Knee Extensor Torque [ Time Frame: Basline and Post Intervention ]Measures strength of the knee flexors and extensor muscles.
- Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Basline and Post Intervention ]Questionnaire that assesses quality of life
- Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: Basline and Post Intervention ]Questionnaire that assesses health related quality of life
- Gait Analysis will be performed on a subset of the children enrolled. [ Time Frame: Basline and Post Intervention ]Analyses changes in walking
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): NCT00401154
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Eileen Fowler, PT, PhD||University of California at Los Angeles|