Cerebral PalsyNCT00472914
Use of EMG to Assess Clinical Hypertonia
An observational study of Cerebral Palsy and Hypertonia, run by University of Southern California at 1 site in United States.
Trial summary
A handheld surface electromyography device will be tested by clinicians on children with limb hypertonia, and inter-rater reliability will be assessed with and without the device. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Hypertonia, Spasticity
- What is being tested?
- portable surface electromyography
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2007
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6-18
- hypertonia in at least one limb due to spasticity
Who cannot join
- any condition that would increase the risk of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initial Assessment of the Use of Surface Electromyography as a Tool for Clinical Evaluation of Hypertonia in Children
A handheld surface electromyography device will be tested by clinicians on children with limb hypertonia, and inter-rater reliability will be assessed with and without the device.
Read the detailed description
Hypothesis:
Qualitative surface EMG measurement during passive movement will increase the inter-rater reliability of clinicians for diagnosis of spasticity and dystonia in children with hypertonia.
Specific Aims:
- Develop a handheld surface EMG device with auditory output that can be used similarly to a stethoscope to listen non-invasively to the activity of muscles.
- Provide clinicians at 5 different institutions with a device to test for 2 months in their own clinics.
- Bring all 5 clinicians to Stanford University for a single-day exercise in which each clinician will examine 10 children with hypertonia. Each clinician will rate the children without using the device, and then again with the device. Intra-class correlations and kappa statistics will be used to assess whether the use of the device leads to improved inter-rater reliability.
- Conditions
- Cerebral Palsy, Hypertonia, Spasticity, Dystonia, Rigidity
- Being tested
- portable surface electromyography
- Keywords
- Hypertonia, Childhood
- Medical subject headings
- Cerebral Palsy, Muscle Hypertonia, Muscle Spasticity, Dystonia, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portable surface electromyographyDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startJan 2007
- Study completionMar 2007
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.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 14 participants
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terence Sanger, University of Southern California
- Investigators
- Terence D Sanger, Md, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472914
- Sponsor's protocol ID
- EMG auditory
- Status last verified
- May 2014
- First submitted
- 11 May 2007
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Assessment of the Use of Surface Electromyography as a Tool for Clinical Evaluation of Hypertonia in Children
- ClinicalTrials.gov ID
- NCT00472914
- Acronym / sponsor ID
- EMG auditory
- Conditions
- Cerebral Palsy, Hypertonia, Spasticity, Dystonia, Rigidity
- Keywords
- Hypertonia, Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Mar 2007 (actual)
- First posted
- 14 May 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.
A handheld surface electromyography device will be tested by clinicians on children with limb hypertonia, and inter-rater reliability will be assessed with and without the device.
Detailed description
Hypothesis:
Qualitative surface EMG measurement during passive movement will increase the inter-rater reliability of clinicians for diagnosis of spasticity and dystonia in children with hypertonia.
Specific Aims:
- Develop a handheld surface EMG device with auditory output that can be used similarly to a stethoscope to listen non-invasively to the activity of muscles.
- Provide clinicians at 5 different institutions with a device to test for 2 months in their own clinics.
- Bring all 5 clinicians to Stanford University for a single-day exercise in which each clinician will examine 10 children with hypertonia. Each clinician will rate the children without using the device, and then again with the device. Intra-class correlations and kappa statistics will be used to assess whether the use of the device leads to improved inter-rater reliability.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 6-18
- hypertonia in at least one limb due to spasticity
Key exclusion criteria (1 listed)
- any condition that would increase the risk of participation
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 |
|---|---|---|
| portable surface electromyography | Device | – |
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 23 May 2014.
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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.
Terence D Sanger, Md, PhD principal investigator
Stanford University
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 and Hypertonia, 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 2 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 23 May 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.
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 23 May 2014.