Cerebral PalsyPhase 1/2NCT01086670
Physical, Functional and Neural Effects of Two Lower Extremity Exercise Protocols in Children With Cerebral Palsy
A Phase 1/2 study testing Physical Exercise in people with Cerebral Palsy and Children, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs and causes difficulty with leg movement and walking. Research has shown that exercise can help those with CP learn to move their arms better, but more research is needed to determine whether exercise programs can improve… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cerebral Palsy, Children, Adolescents
- What is being tested?
- Physical Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2010to 9 May 2016
- Phase
- Phase 1/2
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For those without CP (healthy volunteers)
- Must be between the ages of 5-17, inclusive
- Must be in good general health
- Must be able to understand and comply with the requirements of the study
- For those with CP
- Must be between the ages of 5-17, inclusive
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- Have a diagnosis of spastic bilateral cerebral palsy
- Documentation on previous MRI of peri-ventricular white matter injury
- Able to walk at least 20 feet without stopping and without the need for assistance by another person. A hand-held assistive device (e.g. cane, walker) may be used if necessary.
- Be able to understand and comply with the requirements of the study
- Availability of an adult who agrees to be primarily responsible for completing the reporting requirements for the study and supervising the exercise program
Who cannot join
- For those without CP (healthy volunteers)
- 1. Have a history of musculoskeletal or neurological injury or disorder or general medical condition that would affect the use of the legs or limit the ability to safely perform motor testing
- For those with CP:
- Receiving oral or intrathecal baclofen, which may depress neural plasticity, at the time of enrollment or during the study period
- Had surgery to the lower extremities in the past year or any major surgery within the past 6 months
- Presence of any major medical illness that would limit the ability to safely tolerate the exercise program
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- Requiring or desiring to have botulinum toxin injections within four months before or at any time during the study period.
- Requiring the use of a device that provides support of the pelvis when walking (e.g. gait trainer)
- If choosing to participate in the exercise program, cannot be currently using an exercise machine or start using one during the study period.
- ADDITIONAL EXCLUSION CRITERIA FOR THOSE HAVING A MRI:
- Pregnancy: For any female of childbearing potential who is not pregnant, a pregnancy test will be done.
- A ventriculo-peritoneal shunt
- Claustrophobia
- Metal fragments, wires or implants in the brain or in any part of the skin or body
- Excessive startle reaction to or fear of loud noises
- Inability to remain still and quiet for up to five minutes at a time
- Inability to be off levodopa for at least 24 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Physical, Functional and Neural Effects of Two Lower Extremity Exercise Programs in Children With Cerebral Palsy
Background:
- Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs and causes difficulty with leg movement and walking. Research has shown that exercise can help those with CP learn to move their arms better, but more research is needed to determine whether exercise programs can improve leg movements in people with CP.
- Walking on a treadmill with the help of a physical therapist has improved the treatment outcomes of some individuals with spinal cord injuries. Many children with CP already have physical therapy but still have trouble with walking and leg coordination. Two other kinds of exercise machines, a stationary bicycle and an elliptical machine, used in the home, may be able to help children with CP walk better and move their legs better.
Read more
Objectives:
- To see how children with cerebral palsy (CP) move their legs differently from children without CP.
- To see if an exercise program can improve leg coordination in children with CP.
Eligibility:
- Children between 5 and 17 years of age who either have spastic diplegia CP or are healthy volunteers.
Design:
- Children who are able and willing will have magnetic resonance imaging (MRI) scans at the start and the end of the study.
- During Part I of the study, participants will demonstrate their leg and muscle function with the following tests:
- Measurement of leg size and movement
- Combined camera motion study and electrical impulse evaluation to assess how well the participant walks (with or without an assistive device, as needed)
- Leg movement tests on an exercise bicycle and elliptical machine
- Tests of leg muscle strength, stiffness, and effectiveness
- Ultrasound scans of leg muscle
- Parents of participants will complete computer-based questionnaires about their child s motor abilities.
- A smaller group of participants will continue to Part II of the study, which involves regular exercise of 20 minutes a day, 5 days a week, for 3 months, on a stationary bicycle or elliptical trainer. Half of the group will start this exercise program immediately after the first part of the study, while the other half will wait 3 months before beginning the exercise program.
- During Part II, participants will return to the clinical center for two more sets of the tests and evaluations performed in Part I.
Read the detailed description
Objectives:
Our primary objectives are to: 1) characterize and compare lower extremity motor coordination in children with cerebral palsy (CP) across mobility levels and to children without CP; and 2) evaluate the effects of two home-based exercise programs on motor coordination, as well as other physical, functional and neurological outcomes in children with CP. We hypothesize children with CP will exhibit significant coordination deficits compared to those without CP and that each exercise program will lead to significant improvements in outcomes.
Study Population:
Objective 1 will include 60 ambulatory children with spastic diplegic CP (20 in each of three mobility levels) and 20 children without CP within the same age range. Forty (40) children with CP will participate in Objective 2; 20 in each exercise group.
Design:
In Objective 1, the multiple measures taken at a single point in time will be compared across the three CP and the control groups. Children with CP from Objective 1 will be invited consecutively to participate in the exercise program (Objective 2), until enrollment is complete. Participation in Objective 2 lasts for 6 months. Subjects will be randomly assigned to use one of two novel lower extremity exercise devices: a motor-assisted cycle or an elliptical trainer. Children will exercise for 20 minutes, 5 days a week for 12 consecutive weeks. The major goal of each is to increase the ability to cycle or step at a rapid pace (the target goal is 40 RPM), with resistance added once speed goals are attained and thereafter progressed gradually. The timing of the exercise period (immediate vs. delayed for 3 months) will also be randomly assigned allowing assessors to be masked to group assignment.
Outcome Measures:
The primary outcome is the difference (Objective 1) or pre to post-exercise change (Objective 2) in coordination as measured by the fastest active (voluntary) cadence with each device. Additional coordination measures include cadence at free speed, variability in cadence, and EMG reciprocation vs. synchronization. Selective Control Assessment for the Lower extremity (SCALE), strength and spasticity tests and ultrasound measures of muscle size will be assessed at each time point. These will be compared across groups and before and after the two exercise programs. Functional outcomes include gait speed and two validated computer-based questionnaires. Neural outcomes include selected measures of gray and white matter connectivity as assessed with fcMRI and DTI, respectively.
- Conditions
- Cerebral Palsy, Children, Adolescents
- Being tested
- Physical Exercise
- Keywords
- Coordination, Neuroimaging, Motion Analysis, Locomotor
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseOther
Children will be assigned either an elliptical machine or cycle to take home. Each exercise will be performed for 20 minutes per day, 5 days per week for a period of 12 consecutive weeks, or 60 sessions in all. To avoid excessive fatigue or over-training effects, children are asked to adhere to this exact schedule and not to exercise more than this. Children are asked to complete as many of the sessions as they can. To allow for sick days or vacation during the program, the duration of the training can be extended up to 2 more weeks if needed to try to complete all 60 sessions. Compliance (percent sessions completed) will be correlated with outcomes in the statistical analyses.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Subjects will be randomly assigned to use one of two novel lower extremity exercise devices: a motor-assisted cycle or an elliptical trainer. Receives: Other: Physical Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coordination as measured by fast cadence during device and walking
Cadence is the number of device cycles or gait cycles performed in a minute.
Measured: per test, 3 months post test, 3 months follow up
Secondary outcomes (1)
3D Motion Capture of walking, cycling and elliptical, Surface electromyography, Selective Control Assessment of Lower Extremities, Physical examination, Muscle Ultrasound. strength and spasticity, Questionnaires, Magnetic Resonance Imaging
Tests will be presented in the same order at each assessment, with the 3D motion assessments of the cycling and steppingperformed first since these involve collection of the primary outcome measure, cadence.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study start30 Mar 2010
- Primary completion12 Jan 2015
- Study completion9 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Diane L Damiano, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086670
- Sponsor's protocol ID
- 100073
- Other IDs
- 10-CC-0073
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2010
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical, Functional and Neural Effects of Two Lower Extremity Exercise Programs in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01086670
- Acronym / sponsor ID
- 100073
- Conditions
- Cerebral Palsy, Children, Adolescents
- Keywords
- Coordination, Neuroimaging, Motion Analysis, Locomotor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 30 Mar 2010 (actual)
- Primary completion
- 12 Jan 2015 (actual)
- Study completion
- 9 May 2016 (actual)
- First posted
- 15 Mar 2010 (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.
Background:
- Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs and causes difficulty with leg movement and walking. Research has shown that exercise can help those with CP learn to move their arms better, but more research is needed to determine whether exercise programs can improve leg movements in people with CP.
- Walking on a treadmill with the help of a physical therapist has improved the treatment outcomes of some individuals with spinal cord injuries. Many children with CP already have physical therapy but still have trouble with walking and leg coordination. Two other kinds of exercise machines, a stationary bicycle and an elliptical machine, used in the home, may be able to help children with CP walk better and move their legs better.
Objectives:
- To see how children with cerebral palsy (CP) move their legs differently from children without CP.
- To see if an exercise program can improve leg coordination in children with CP.
Eligibility:
- Children between 5 and 17 years of age who either have spastic diplegia CP or are healthy volunteers.
Design:
- Children who are able and willing will have magnetic resonance imaging (MRI) scans at the start and the end of the study.
- During Part I of the study, participants will demonstrate their leg and muscle function with the following tests:
- Measurement of leg size and movement
- Combined camera motion study and electrical impulse evaluation to assess how well the participant walks (with or without an assistive device, as needed)
- Leg movement tests on an exercise bicycle and elliptical machine
- Tests of leg muscle strength, stiffness, and effectiveness
- Ultrasound scans of leg muscle
- Parents of participants will complete computer-based questionnaires about their child s motor abilities.
- A smaller group of participants will continue to Part II of the study, which involves regular exercise of 20 minutes a day, 5 days a week, for 3 months, on a stationary bicycle or elliptical trainer. Half of the group will start this exercise program immediately after the first part of the study, while the other half will wait 3 months before beginning the exercise program.
- During Part II, participants will return to the clinical center for two more sets of the tests and evaluations performed in Part I.
Detailed description
Objectives:
Our primary objectives are to: 1) characterize and compare lower extremity motor coordination in children with cerebral palsy (CP) across mobility levels and to children without CP; and 2) evaluate the effects of two home-based exercise programs on motor coordination, as well as other physical, functional and neurological outcomes in children with CP. We hypothesize children with CP will exhibit significant coordination deficits compared to those without CP and that each exercise program will lead to significant improvements in outcomes.
Study Population:
Objective 1 will include 60 ambulatory children with spastic diplegic CP (20 in each of three mobility levels) and 20 children without CP within the same age range. Forty (40) children with CP will participate in Objective 2; 20 in each exercise group.
Design:
In Objective 1, the multiple measures taken at a single point in time will be compared across the three CP and the control groups. Children with CP from Objective 1 will be invited consecutively to participate in the exercise program (Objective 2), until enrollment is complete. Participation in Objective 2 lasts for 6 months. Subjects will be randomly assigned to use one of two novel lower extremity exercise devices: a motor-assisted cycle or an elliptical trainer. Children will exercise for 20 minutes, 5 days a week for 12 consecutive weeks. The major goal of each is to increase the ability to cycle or step at a rapid pace (the target goal is 40 RPM), with resistance added once speed goals are attained and thereafter progressed gradually. The timing of the exercise period (immediate vs. delayed for 3 months) will also be randomly assigned allowing assessors to be masked to group assignment.
Outcome Measures:
The primary outcome is the difference (Objective 1) or pre to post-exercise change (Objective 2) in coordination as measured by the fastest active (voluntary) cadence with each device. Additional coordination measures include cadence at free speed, variability in cadence, and EMG reciprocation vs. synchronization. Selective Control Assessment for the Lower extremity (SCALE), strength and spasticity tests and ultrasound measures of muscle size will be assessed at each time point. These will be compared across groups and before and after the two exercise programs. Functional outcomes include gait speed and two validated computer-based questionnaires. Neural outcomes include selected measures of gray and white matter connectivity as assessed with fcMRI and DTI, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Physical ExerciseSubjects will be randomly assigned to use one of two novel lower extremity exercise devices: a motor-assisted cycle or an elliptical trainer. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- For those without CP (healthy volunteers)
- Must be between the ages of 5-17, inclusive
- Must be in good general health
- Must be able to understand and comply with the requirements of the study
- For those with CP
Key exclusion criteria (17 listed)
- For those without CP (healthy volunteers)
- 1. Have a history of musculoskeletal or neurological injury or disorder or general medical condition that would affect the use of the legs or limit the ability to safely perform motor testing
- For those with CP:
- Receiving oral or intrathecal baclofen, which may depress neural plasticity, at the time of enrollment or during the study period
- Had surgery to the lower extremities in the past year or any major surgery within the past 6 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 |
|---|---|---|
| Physical ExerciseChildren will be assigned either an elliptical machine or cycle to take home. Each exercise will be performed for 20 minutes per day, 5 days per week for a period of 12 consecutive weeks, or 60 sessions in all. To avoid excessive fatigue or over-training effects, children are asked to adhere to this exact schedule and not to exercise more than this. Children are asked to complete as many of the sessions as they can. To allow for sick days or vacation during the program, the duration of the training can be extended up to 2 more weeks if needed to try to complete all 60 sessions. Compliance (percent sessions completed) will be correlated with outcomes in the statistical analyses. | Other | 1 |
Primary outcome
Coordination as measured by fast cadence during device and walking
Time frame: per test, 3 months post test, 3 months follow up
Cadence is the number of device cycles or gait cycles performed in a minute.
1 secondary outcome
3D Motion Capture of walking, cycling and elliptical, Surface electromyography, Selective Control Assessment of Lower Extremities, Physical examination, Muscle Ultrasound. strength and spasticity, Questionnaires, Magnetic Resonance Imaging
Time frame: 12 weeks
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 29 Mar 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Diane L Damiano, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Physical Exercise in people with Cerebral Palsy and Children, run by National Institutes of Health Clinical Center (CC) 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 11 inclusion and 17 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 29 Mar 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Coordination as measured by fast cadence during device and walking (time frame: per test, 3 months post test, 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2022.