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

NCT00401154 | Completed DMC

• 1 other identifier: HS-025023-CR001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Gross Motor Function Measure-66 (GMFM)

  Describes gross motor function in children with cerebral palsy.

  Basline and Post Intervention

• 600 Yard Walk-Run Test

  Timed test to show how rapidly the subject can walk or run 600 yards.

  Baseline and Post Intervention

• 30 Second Walk Test

  Timed test to measure the distance a subject walks in 30 seconds.

  Basline and Post Intervention

• Knee Flexor and Knee Extensor Torque

  Measures strength of the knee flexors and extensor muscles.

  Basline and Post Intervention

• Pediatric Quality of Life Inventory (PedsQL)

  Questionnaire that assesses quality of life

  Basline and Post Intervention

• Pediatric Outcomes Data Collection Instrument (PODCI)

  Questionnaire that assesses health related quality of life

  Basline and Post Intervention

Secondary Outcomes (1)

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

  Basline and Post Intervention

Study Arms (1)

Intervention Stationary Cycling

EXPERIMENTAL

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

Other: Stationary Cycling

Interventions

Stationary Cycling OTHER

Use of a stationary bicycle for exercise

Intervention Stationary Cycling

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Physical Therapy Clinical Research Network: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (2)

• 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.

  PMID: 22582760 DERIVED

• 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.

  PMID: 20093327 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Eileen Fowler, PT, PhD

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Physical Therapy

Study Record Dates

• First Submitted: November 15, 2006
• First Posted: November 17, 2006
• Study Start: September 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

US (1)