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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by University of Southern California.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Physical Therapy Clinical Research Network
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00401154
First received: November 15, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted

November 15, 2006
November 15, 2006
September 2003
Not Provided
  • 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)
Same as current
No Changes Posted
Gait Analysis will be performed on a subset of the children enrolled.
Same as current
Not Provided
Not Provided
 
Study of a Stationary Cycling Intervention for Children With Spastic Diplegic Cerebral Palsy
Pediatric Endurance and Limb Strengthening (PEDALS)

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Spastic Diplegic Cerebral Palsy
Behavioral: Stationary Cycling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
January 2006
Not Provided

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.
Both
7 Years to 18 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00401154
HS-025023-CR001
Not Provided
Not Provided
University of Southern California
Physical Therapy Clinical Research Network
Principal Investigator: Eileen Fowler, PT, PhD University of California at Los Angeles
University of Southern California
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP