Spastic Diplegic Cerebral PalsyPEDALSNCT00401154
Study of a Stationary Cycling Intervention for Children With Spastic Diplegic Cerebral Palsy
A study testing Stationary Cycling in people with Spastic Diplegic Cerebral Palsy, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy
- What is being tested?
- Stationary Cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Pediatric Endurance and Limb Strengthening (PEDALS)
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
- Being tested
- Stationary Cycling
- Keywords
- Spastic Diplegia, Cerebral Palsy, Children, Adolescents, Strengthening, Endurance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stationary CyclingOther
Use of a stationary bicycle for exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention Stationary Cycling | Experimental | Subjects receiving the intervention performed stationary cycling 3 times a week for 30 sessions over 12 weeks. Receives: Other: Stationary Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-66 (GMFM)
Describes gross motor function in children with cerebral palsy.
Measured: Basline and Post Intervention
600 Yard Walk-Run Test
Timed test to show how rapidly the subject can walk or run 600 yards.
Measured: Baseline and Post Intervention
30 Second Walk Test
Timed test to measure the distance a subject walks in 30 seconds.
Measured: Basline and Post Intervention
Knee Flexor and Knee Extensor Torque
Measures strength of the knee flexors and extensor muscles.
Measured: Basline and Post Intervention
Pediatric Quality of Life Inventory (PedsQL)
Questionnaire that assesses quality of life
Measured: Basline and Post Intervention
Pediatric Outcomes Data Collection Instrument (PODCI)
Questionnaire that assesses health related quality of life
Measured: Basline and Post Intervention
Secondary outcomes (1)
Gait Analysis will be performed on a subset of the children enrolled.
Analyses changes in walking
Measured: Basline and Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startSep 2003
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spastic Diplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Physical Therapy Clinical Research Network
- Responsible party
- Principal investigator, Sharon K. DeMuth, University of Southern California
- Investigators
- Eileen Fowler, PT, PhD, Principal investigator, University of California at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401154
- Sponsor's protocol ID
- HS-025023-CR001
- Acronym
- PEDALS
- Status last verified
- Dec 2014
- First submitted
- 15 Nov 2006
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22582760Fowler 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.
PubMed 20093327
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Endurance and Limb Strengthening (PEDALS)
- ClinicalTrials.gov ID
- NCT00401154
- Acronym / sponsor ID
- PEDALS / HS-025023-CR001
- Conditions
- Spastic Diplegic Cerebral Palsy
- Keywords
- Spastic Diplegia, Cerebral Palsy, Children, Adolescents, Strengthening, Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Physical Therapy Clinical Research Network
- Study start
- Sep 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 17 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Stationary Cycling | Experimental | Other: Stationary CyclingSubjects receiving the intervention performed stationary cycling 3 times a week for 30 sessions over 12 weeks. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stationary CyclingUse of a stationary bicycle for exercise | Other | Intervention Stationary Cycling |
Primary outcome
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
1 secondary outcome
Gait Analysis will be performed on a subset of the children enrolled.
Time frame: Basline and Post Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Derived from this study: PubMed 22582760Demuth 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.
- Derived from this study: PubMed 20093327Fowler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen Fowler, PT, PhD principal investigator
University of California at Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stationary Cycling in people with Spastic Diplegic Cerebral Palsy, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure-66 (GMFM) (time frame: Basline and Post Intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00401154, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.