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

Study Overview
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Brief Summary
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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).

Official Title
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Pediatric Endurance and Limb Strengthening (PEDALS)

Conditions
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Spastic Diplegic Cerebral Palsy

Intervention / Treatment
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* Other: Stationary Cycling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Stationary Cycling<br>Subjects receiving the intervention performed stationary cycling 3 times a week for 30 sessions over 12 weeks. | Other: Stationary Cycling<br>* Use of a stationary bicycle for exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measure-66 (GMFM) | Describes gross motor function in children with cerebral palsy. | Basline and Post Intervention | 
| 600 Yard Walk-Run Test | Timed test to show how rapidly the subject can walk or run 600 yards. | Baseline and Post Intervention | 
| 30 Second Walk Test | Timed test to measure the distance a subject walks in 30 seconds. | Basline and Post Intervention | 
| Knee Flexor and Knee Extensor Torque | Measures strength of the knee flexors and extensor muscles. | Basline and Post Intervention | 
| Pediatric Quality of Life Inventory (PedsQL) | Questionnaire that assesses quality of life | Basline and Post Intervention | 
| Pediatric Outcomes Data Collection Instrument (PODCI) | Questionnaire that assesses health related quality of life | Basline and Post Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Analysis will be performed on a subset of the children enrolled. | Analyses changes in walking | Basline and Post Intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spastic Diplegia, Cerebral Palsy, Children, Adolescents, Strengthening, Endurance