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

December 4, 2014 updated by: Sharon K. DeMuth, University of Southern California

Pediatric Endurance and Limb Strengthening (PEDALS)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Physical Therapy Clinical Research Network

Investigators

  • Principal Investigator: Eileen Fowler, PT, PhD, University of California at Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

November 15, 2006

First Submitted That Met QC Criteria

November 15, 2006

First Posted (Estimate)

November 17, 2006

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-025023-CR001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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