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
  Purpose

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).


Condition Intervention
Spastic Diplegic Cerebral Palsy
Other: Stationary Cycling

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatric Endurance and Limb Strengthening (PEDALS)

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Gross Motor Function Measure-66 (GMFM) [ Time Frame: Basline and Post Intervention ] [ Designated as safety issue: No ]
    Describes gross motor function in children with cerebral palsy.

  • 600 Yard Walk-Run Test [ Time Frame: Baseline and Post Intervention ] [ Designated as safety issue: No ]
    Timed test to show how rapidly the subject can walk or run 600 yards.

  • 30 Second Walk Test [ Time Frame: Basline and Post Intervention ] [ Designated as safety issue: No ]
    Timed test to measure the distance a subject walks in 30 seconds.

  • Knee Flexor and Knee Extensor Torque [ Time Frame: Basline and Post Intervention ] [ Designated as safety issue: No ]
    Measures strength of the knee flexors and extensor muscles.

  • Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Basline and Post Intervention ] [ Designated as safety issue: No ]
    Questionnaire that assesses quality of life

  • Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: Basline and Post Intervention ] [ Designated as safety issue: No ]
    Questionnaire that assesses health related quality of life


Secondary Outcome Measures:
  • Gait Analysis will be performed on a subset of the children enrolled. [ Time Frame: Basline and Post Intervention ] [ Designated as safety issue: No ]
    Analyses changes in walking


Enrollment: 64
Study Start Date: September 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00401154

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Physical Therapy Clinical Research Network
Investigators
Principal Investigator: Eileen Fowler, PT, PhD University of California at Los Angeles
  More Information

No publications provided by University of Southern California

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sharon K. DeMuth, Assistant Professor of Clinical Physical Therapy, University of Southern California
ClinicalTrials.gov Identifier: NCT00401154     History of Changes
Other Study ID Numbers: HS-025023-CR001
Study First Received: November 15, 2006
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Spastic Diplegia
Cerebral Palsy
Children
Adolescents
Strengthening
Endurance

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 25, 2015