Study of a Stationary Cycling Intervention for Children With Spastic Diplegic Cerebral Palsy (PEDALS)

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; (submitted: December 4, 2014)	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
Original Primary Outcome Measures ICMJE; (submitted: November 15, 2006)	All measures will be taken at baseline and followup evaluations, within a two week period after enrollment, and within a two week period after completion of the intervention.; Gross Motor Function Measure (GMFM); 600 Yard Walk-Run Test; 30 Second Walk Test; Knee Flexor and Knee Extensor Torque; PedsQL; Pediatric Outcomes Data Collection Instrument (PODCI)
Change History	Complete list of historical versions of study NCT00401154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 4, 2014)	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; (submitted: November 15, 2006)	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 *	Demuth SK, Knutson LM, Fowler EG. The PEDALS stationary cycling intervention and health-related quality of life in children with cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2012 Jul;54(7):654-61. doi: 10.1111/j.1469-8749.2012.04321.x. Epub 2012 May 14.; Fowler EG, Knutson LM, Demuth SK, Siebert KL, Simms VD, Sugi MH, Souza RB, Karim R, Azen SP; Physical Therapy Clinical Research Network (PTClinResNet). Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):367-81. doi: 10.2522/ptj.20080364. Epub 2010 Jan 21.
* 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; (submitted: December 4, 2014)	64
Original Enrollment ICMJE; (submitted: November 15, 2006)	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: between the ages of 7 and 16 years and engaged in regular education as their primary academic path (children receiving resource help will not be excluded); - ability to follow simple verbal directions;; good or fair selective motor control for at least one limb; and; ability to walk independently, with or without assistive devices, for short distances. The lowest level of walking ability for inclusion is independent walking indoors but limitations outdoors and in the community, requiring the use of a wheelchair in these settings. These criteria for walking ability place subjects in Levels I-III of the Gross Motor Functional Classification System (GMFCS) (Palisano et al., 1997). Exclusion Criteria: musculoskeletal or neurosurgical surgery or baclofen pump implantation within the past year;; botulinum toxin injections within the past 6 months;; serial casting or new orthotics within the past 3 months;; initiating or increasing oral medications that affect the neuromuscular system, e.g. baclofen, within the past 3 months;; onset of physical therapy, exercise, sport activity, or change in assistive devices for walking within the past 3 months;; inability or unwillingness to maintain age appropriate behavior;; serious medical conditions such as cardiac disease, diabetes, asthma, or uncontrolled seizures;; current participation in a fitness program, that includes a cardiorespiratory endurance exercise, at least one time per week;; significant hip joint contractures so that the hip cannot be passively moved throughout an excursion between 30 and 80 degrees;; significant knee joint contractures so that the knee cannot be passively moved throughout an excursion between 40 and 110 degrees; and; significant ankle joint contractures so that the ankle cannot be passively moved throughout an excursion of -10 to 20 degrees of plantarflexion. Exclusion criteria 8 - 10 are based on passive joint excursions necessary to perform stationary cycling (Ericson et al., 1988) allowing for some hip and knee joint compensation for subjects without ankle dorsiflexion range of motion.
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Eileen Fowler, PT, PhD University of California at Los Angeles
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