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

Spastic Diplegic Cerebral Palsy Clinical Trial

— PEDALS  

Official title:

Pediatric Endurance and Limb Strengthening (PEDALS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401154
• Other study ID #: HS-025023-CR001
• Status: Completed
• Phase: N/A
• First received: November 15, 2006
• Last updated: December 4, 2014
• Start date: September 2003
• Est. completion date: March 2006

Study information

• Verified date: December 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spastic Diplegic Cerebral Palsy

Intervention

Other:
• Stationary Cycling
Use of a stationary bicycle for exercise

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Physical Therapy Clinical Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Measure-66 (GMFM)	Describes gross motor function in children with cerebral palsy.	Basline and Post Intervention	No
Primary	600 Yard Walk-Run Test	Timed test to show how rapidly the subject can walk or run 600 yards.	Baseline and Post Intervention	No
Primary	30 Second Walk Test	Timed test to measure the distance a subject walks in 30 seconds.	Basline and Post Intervention	No
Primary	Knee Flexor and Knee Extensor Torque	Measures strength of the knee flexors and extensor muscles.	Basline and Post Intervention	No
Primary	Pediatric Quality of Life Inventory (PedsQL)	Questionnaire that assesses quality of life	Basline and Post Intervention	No
Primary	Pediatric Outcomes Data Collection Instrument (PODCI)	Questionnaire that assesses health related quality of life	Basline and Post Intervention	No
Secondary	Gait Analysis will be performed on a subset of the children enrolled.	Analyses changes in walking	Basline and Post Intervention	No