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

Not Applicable

Completed

• Conditions: Spastic Diplegic Cerebral Palsy
• Interventions: Other: Stationary Cycling

• Registration Number: NCT00401154
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-15
• Study First Posted: 2006-11-17
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Stationary Cycling	Stationary Cycling	Subjects receiving the intervention performed stationary cycling 3 times a week for 30 sessions over 12 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Gait Analysis will be performed on a subset of the children enrolled.	Basline and Post Intervention	Analyses changes in walking

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States