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

NCT ID: NCT00401154

Last Updated: 2014-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2006-03-31

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).

Conditions

Spastic Diplegic Cerebral Palsy

Keywords

Spastic Diplegia; Cerebral Palsy; Children; Adolescents; Strengthening; Endurance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Stationary Cycling

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

Group Type: EXPERIMENTAL

Stationary Cycling

Intervention Type: OTHER

Use of a stationary bicycle for exercise

Interventions

Stationary Cycling

Use of a stationary bicycle for exercise

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Physical Therapy Clinical Research Network

NETWORK

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Sharon K. DeMuth

Assistant Professor of Clinical Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eileen Fowler, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California at Los Angeles

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22582760 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20093327 (View on PubMed)

Other Identifiers

HS-025023-CR001

Identifier Type: -

Identifier Source: org_study_id