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

Pediatric Endurance and Limb Strengthening (PEDALS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00401154
Acronym
PEDALS
Enrollment
64
Registered
2006-11-17
Start date
2003-09-30
Completion date
2006-03-31
Last updated
2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic Diplegic Cerebral Palsy

Keywords

Spastic Diplegia, Cerebral Palsy, Children, Adolescents, Strengthening, Endurance

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).

Interventions

Use of a stationary bicycle for exercise

Sponsors

Physical Therapy Clinical Research Network
CollaboratorNETWORK
University of Southern California
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
30 Second Walk TestBasline and Post InterventionTimed test to measure the distance a subject walks in 30 seconds.
Gross Motor Function Measure-66 (GMFM)Basline and Post InterventionDescribes gross motor function in children with cerebral palsy.
600 Yard Walk-Run TestBaseline and Post InterventionTimed test to show how rapidly the subject can walk or run 600 yards.
Pediatric Outcomes Data Collection Instrument (PODCI)Basline and Post InterventionQuestionnaire that assesses health related quality of life
Knee Flexor and Knee Extensor TorqueBasline and Post InterventionMeasures strength of the knee flexors and extensor muscles.
Pediatric Quality of Life Inventory (PedsQL)Basline and Post InterventionQuestionnaire that assesses quality of life

Secondary

MeasureTime frameDescription
Gait Analysis will be performed on a subset of the children enrolled.Basline and Post InterventionAnalyses changes in walking

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026