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

Primary Purpose

Spastic Diplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stationary Cycling
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Diplegic Cerebral Palsy focused on measuring Spastic Diplegia, Cerebral Palsy, Children, Adolescents, Strengthening, Endurance

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Stationary Cycling

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Gait Analysis will be performed on a subset of the children enrolled.
Analyses changes in walking

Full Information

First Posted
November 15, 2006
Last Updated
December 4, 2014
Sponsor
University of Southern California
Collaborators
Physical Therapy Clinical Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT00401154
Brief Title
Study of a Stationary Cycling Intervention for Children With Spastic Diplegic Cerebral Palsy
Acronym
PEDALS
Official Title
Pediatric Endurance and Limb Strengthening (PEDALS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Physical Therapy Clinical Research Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Diplegic Cerebral Palsy
Keywords
Spastic Diplegia, Cerebral Palsy, Children, Adolescents, Strengthening, Endurance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Stationary Cycling
Arm Type
Experimental
Arm Description
Subjects receiving the intervention performed stationary cycling 3 times a week for 30 sessions over 12 weeks.
Intervention Type
Other
Intervention Name(s)
Stationary Cycling
Intervention Description
Use of a stationary bicycle for exercise
Primary Outcome Measure Information:
Title
Gross Motor Function Measure-66 (GMFM)
Description
Describes gross motor function in children with cerebral palsy.
Time Frame
Basline and Post Intervention
Title
600 Yard Walk-Run Test
Description
Timed test to show how rapidly the subject can walk or run 600 yards.
Time Frame
Baseline and Post Intervention
Title
30 Second Walk Test
Description
Timed test to measure the distance a subject walks in 30 seconds.
Time Frame
Basline and Post Intervention
Title
Knee Flexor and Knee Extensor Torque
Description
Measures strength of the knee flexors and extensor muscles.
Time Frame
Basline and Post Intervention
Title
Pediatric Quality of Life Inventory (PedsQL)
Description
Questionnaire that assesses quality of life
Time Frame
Basline and Post Intervention
Title
Pediatric Outcomes Data Collection Instrument (PODCI)
Description
Questionnaire that assesses health related quality of life
Time Frame
Basline and Post Intervention
Secondary Outcome Measure Information:
Title
Gait Analysis will be performed on a subset of the children enrolled.
Description
Analyses changes in walking
Time Frame
Basline and Post Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen Fowler, PT, PhD
Organizational Affiliation
University of California at Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22582760
Citation
Demuth SK, Knutson LM, Fowler EG. The PEDALS stationary cycling intervention and health-related quality of life in children with cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2012 Jul;54(7):654-61. doi: 10.1111/j.1469-8749.2012.04321.x. Epub 2012 May 14.
Results Reference
derived
PubMed Identifier
20093327
Citation
Fowler EG, Knutson LM, Demuth SK, Siebert KL, Simms VD, Sugi MH, Souza RB, Karim R, Azen SP; Physical Therapy Clinical Research Network (PTClinResNet). Pediatric endurance and limb strengthening (PEDALS) for children with cerebral palsy using stationary cycling: a randomized controlled trial. Phys Ther. 2010 Mar;90(3):367-81. doi: 10.2522/ptj.20080364. Epub 2010 Jan 21.
Results Reference
derived

Learn more about this trial

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

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