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

This study has been completed.

Sponsor:

Collaborator:

Physical Therapy Clinical Research Network

Information provided by (Responsible Party):

Sharon K. DeMuth, University of Southern California

ClinicalTrials.gov Identifier:

NCT00401154

First received: November 15, 2006

Last updated: December 4, 2014

Last verified: December 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

November 15, 2006

Last Updated Date

December 4, 2014

Start Date ^ICMJE

September 2003

Primary Completion Date

March 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Gross Motor Function Measure-66 (GMFM) [ Time Frame: Basline and Post Intervention ]
Describes gross motor function in children with cerebral palsy.
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.
30 Second Walk Test [ Time Frame: Basline and Post Intervention ]
Timed test to measure the distance a subject walks in 30 seconds.
Knee Flexor and Knee Extensor Torque [ Time Frame: Basline and Post Intervention ]
Measures strength of the knee flexors and extensor muscles.
Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Basline and Post Intervention ]
Questionnaire that assesses quality of life
Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: Basline and Post Intervention ]
Questionnaire that assesses health related quality of life

Original Primary Outcome Measures ^ICMJE

All measures will be taken at baseline and followup evaluations, within a two week period after enrollment, and within a two week period after completion of the intervention.
Gross Motor Function Measure (GMFM)
600 Yard Walk-Run Test
30 Second Walk Test
Knee Flexor and Knee Extensor Torque
PedsQL
Pediatric Outcomes Data Collection Instrument (PODCI)

Change History

Complete list of historical versions of study NCT00401154 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Gait Analysis will be performed on a subset of the children enrolled. [ Time Frame: Basline and Post Intervention ]

Analyses changes in walking

Original Secondary Outcome Measures ^ICMJE

Gait Analysis will be performed on a subset of the children enrolled.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Pediatric Endurance and Limb Strengthening (PEDALS)

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Spastic Diplegic Cerebral Palsy

Intervention ^ICMJE

Other: Stationary Cycling

Use of a stationary bicycle for exercise

Study Arms

Experimental: Intervention Stationary Cycling

Subjects receiving the intervention performed stationary cycling 3 times a week for 30 sessions over 12 weeks.

Intervention: Other: Stationary Cycling

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

March 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

7 Years to 18 Years (Child, Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00401154

Other Study ID Numbers ^ICMJE

HS-025023-CR001

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Sharon K. DeMuth, University of Southern California

Study Sponsor ^ICMJE

University of Southern California

Collaborators ^ICMJE

Physical Therapy Clinical Research Network

Investigators ^ICMJE

Principal Investigator:

Eileen Fowler, PT, PhD

University of California at Los Angeles

PRS Account

University of Southern California

Verification Date

December 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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