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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
Sponsor:
Collaborator:
Physical Therapy Clinical Research Network
Information provided by (Responsible Party):
Sharon K. DeMuth, University of Southern California

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).

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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Gross Motor Function Measure-66 (GMFM) [ Time Frame: Basline and Post Intervention ]
    Describes gross motor function in children with cerebral palsy.

  2. 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.

  3. 30 Second Walk Test [ Time Frame: Basline and Post Intervention ]
    Timed test to measure the distance a subject walks in 30 seconds.

  4. Knee Flexor and Knee Extensor Torque [ Time Frame: Basline and Post Intervention ]
    Measures strength of the knee flexors and extensor muscles.

  5. Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Basline and Post Intervention ]
    Questionnaire that assesses quality of life

  6. Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: Basline and Post Intervention ]
    Questionnaire that assesses health related quality of life


Secondary Outcome Measures :
  1. Gait Analysis will be performed on a subset of the children enrolled. [ Time Frame: Basline and Post Intervention ]
    Analyses changes in walking



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Physical Therapy Clinical Research Network
Investigators
Principal Investigator: Eileen Fowler, PT, PhD University of California at Los Angeles

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sharon K. DeMuth, Assistant Professor of Clinical Physical Therapy, University of Southern California
ClinicalTrials.gov Identifier: NCT00401154     History of Changes
Other Study ID Numbers: HS-025023-CR001
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by Sharon K. DeMuth, University of Southern California:
Spastic Diplegia
Cerebral Palsy
Children
Adolescents
Strengthening
Endurance

Additional relevant MeSH terms:
Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms