Cerebral PalsyNCT00504049
Wavelet Analysis of Electromyography (EMG) in Cerebral Palsy
An observational study of Cerebral Palsy, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
Several methods exist to evaluate motor function in the child with cerebral palsy and are used to assess the outcome of a clinical intervention. However, these scales are not directed towards measuring the changes in muscle activity patterns that can result from the intervention. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2009
- Phase
- Observational
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with spastic, diplegic cerebral palsy
Who may be able to join
- A diagnosis of spastic diplegic CP
- Must be ambulatory without the use of orthotics
- Between a GMFCS Level I and Level III
- Between the ages of 7 and 13 years
- Cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees)
- Seizure-free or seizure controlled
Show all 10Show fewer
- Has visuoperceptual skills and cognitive/communication skills sufficient to follow multiple step commands and to attend to tasks associated with data collection
- Must be greater than 1 year post-surgery to the lower extremities
- Must be greater then 6 months botulinum toxin injection
- Passive range of motion in lower extremity joints must be greater than 10 degrees of flexion contracture at the hips as measured by the Thomas Test, at least 20 degrees of hip abduction bilaterally, less than 5 degrees of knee flexion contracture, popliteal angle less than 45 degrees, and at least 0 degrees of ankle dorsiflexion with the knee extended while the foot is in varus
Who cannot join
- Children who do not meet the inclusion criteria will not be considered for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Philadelphia, Pennsylvania, 19140
About this study
Official title: Wavelet Analysis of Surface EMG in Cerebral Palsy
Several methods exist to evaluate motor function in the child with cerebral palsy and are used to assess the outcome of a clinical intervention. However, these scales are not directed towards measuring the changes in muscle activity patterns that can result from the intervention. For example, there are classification scales aimed at measuring motor function and functional abilities, and indices of gait function. These scores, while providing a way to quantify function and mechanics, do not directly measure muscle activation characteristics. Therefore, these tests may be insensitive to how the intervention has directly affected muscle function, which is usually the focus of the intervention (i.e. botulinum toxin, functional electrical stimulation, dorsal rhizotomy). Muscle biopsies and motor evoked potentials can provide information about the muscle activation characteristics, however, they are invasive and there are concerns about using these techniques on the pediatric population and/or the practicality of clinical implementation, especially since they do not provide insight into how the muscle behaves during a functional task. One method that can be used to provide insight into muscle activity in a non-invasive and clinically meaningful manner is the use of surface electromyography (sEMG). Surface EMG is typically a routine part of clinical assessment and the evaluation of motor impairment in CP. However, the analysis of the data has been limited in most cases to examination of signal amplitude or differences in muscle onset and offset timing.
The long-term goal of this research is to develop an analysis method for sEMG that can be used during functional tasks for treatment planning, diagnostic, assessment purposes in CP. This is to be accomplished through the use of the continuous wavelet transform (CWT). By developing an assessment method based on muscle activity, it is believed that a clinically viable measurement tool can be devised that will provide a level of insight into the effects of an intervention on muscle pathophysiology that is not currently available. The first step in progressing towards this long-term goal is to determine the variability and range of expected time-frequency patterns that can be expressed in a given population (i.e., cerebral palsy) during the execution of a meaningful task (gait), and relate the time-frequency information back to more standard assessments
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Electromyography, Wavelet Analysis
- Medical subject headings
- Cerebral Palsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startMar 2007
- Study completionMar 2009
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Richard T Lauer, PhD, Principal investigator, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504049
- Sponsor's protocol ID
- 1R03NS048875-01A2
- Status last verified
- Jan 2009
- First submitted
- 17 Jul 2007
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wavelet Analysis of Surface EMG in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00504049
- Acronym / sponsor ID
- 1R03NS048875-01A2
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Electromyography, Wavelet Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2007
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Jul 2007 (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.
Several methods exist to evaluate motor function in the child with cerebral palsy and are used to assess the outcome of a clinical intervention. However, these scales are not directed towards measuring the changes in muscle activity patterns that can result from the intervention. For example, there are classification scales aimed at measuring motor function and functional abilities, and indices of gait function. These scores, while providing a way to quantify function and mechanics, do not directly measure muscle activation characteristics. Therefore, these tests may be insensitive to how the intervention has directly affected muscle function, which is usually the focus of the intervention (i.e. botulinum toxin, functional electrical stimulation, dorsal rhizotomy). Muscle biopsies and motor evoked potentials can provide information about the muscle activation characteristics, however, they are invasive and there are concerns about using these techniques on the pediatric population and/or the practicality of clinical implementation, especially since they do not provide insight into how the muscle behaves during a functional task. One method that can be used to provide insight into muscle activity in a non-invasive and clinically meaningful manner is the use of surface electromyography (sEMG). Surface EMG is typically a routine part of clinical assessment and the evaluation of motor impairment in CP. However, the analysis of the data has been limited in most cases to examination of signal amplitude or differences in muscle onset and offset timing.
The long-term goal of this research is to develop an analysis method for sEMG that can be used during functional tasks for treatment planning, diagnostic, assessment purposes in CP. This is to be accomplished through the use of the continuous wavelet transform (CWT). By developing an assessment method based on muscle activity, it is believed that a clinically viable measurement tool can be devised that will provide a level of insight into the effects of an intervention on muscle pathophysiology that is not currently available. The first step in progressing towards this long-term goal is to determine the variability and range of expected time-frequency patterns that can be expressed in a given population (i.e., cerebral palsy) during the execution of a meaningful task (gait), and relate the time-frequency information back to more standard assessments
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with spastic, diplegic cerebral palsy
Key inclusion criteria (10 listed)
- A diagnosis of spastic diplegic CP
- Must be ambulatory without the use of orthotics
- Between a GMFCS Level I and Level III
- Between the ages of 7 and 13 years
- Cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees)
Key exclusion criteria (1 listed)
- Children who do not meet the inclusion criteria will not be considered for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 22 Jul 2010.
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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.
Richard T Lauer, PhD principal investigator
Shriners Hospitals for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Shriners Hospitals for Children 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 10 inclusion and 1 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 22 Jul 2010. 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.
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 22 Jul 2010; AzTrials last refreshed its copy on 7 Nov 2026.