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Completed

NCT Number: NCT00401154

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

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).

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stationary Cycling

Other

Use of a stationary bicycle for exercise

Primary outcomes

  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 outcomes

  1. Gait Analysis will be performed on a subset of the children enrolled.

    Time frame: Basline and Post Intervention

    Analyses changes in walking

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Physical Therapy Clinical Research Network

Registry information

Official study title

Pediatric Endurance and Limb Strengthening (PEDALS)

Acronym: PEDALS

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Nov 17, 2006
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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