Study of a Stationary Cycling Intervention for Children With Spastic Diplegic Cerebral Palsy - Full Text View

Sponsors and Collaborators:	University of Southern California Physical Therapy Clinical Research Network
Information provided by:	University of Southern California
ClinicalTrials.gov Identifier:	NCT00401154

Purpose

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	Intervention	Phase
Spastic Diplegic Cerebral Palsy	Behavioral: Stationary Cycling	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment
Official Title:	Pediatric Endurance and Limb Strengthening (PEDALS)

Resource links provided by NLM:

MedlinePlus related topics: Cerebral Palsy Exercise and Physical Fitness Paralysis

U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:

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)

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	September 2003
Estimated Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	7 Years to 18 Years
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Study ID Numbers:	HS-025023-CR001
Study First Received:	November 15, 2006
Last Updated:	November 15, 2006
ClinicalTrials.gov Identifier:	NCT00401154 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Southern California:

Spastic Diplegia
Cerebral Palsy
Children

Adolescents
Strengthening
Endurance

Study placed in the following topic categories:

Paralysis
Cerebral Palsy
Brain Damage, Chronic

Central Nervous System Diseases
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 03, 2009